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Work Procedures of New Drugs Development Department

I. New product information collection

    The development department collects relevant product information based on the overall strategy of the company. Information collection is always a daily task of the development Department.A wealth of relevant information informs product development decisions.Therefore, the development to the Chinese medicine newspaper, "Chinese medicine economic news," the health "as the window of information collection, around the series products of the company set the development of children's strategy of actively collect information about children's cold medicine, in children collect related market information at the same time, further improve the Ed Koch, second-hand material, And keep an eye on what competitors are doing.

Ii. New product screening and proposal

    With the support of sufficient information, the development Department shall conduct product screening by following steps:

    1. Is the product market in line with the company's current strategic vision?

    2. Is the technology of this product perfect at present?Can our existing human resources meet the technical requirements of this product?

    3. Is the market for this product mature?Is our company competent enough to intervene in this market?

    4. Can our company's financial resources meet the cost of product development and early-stage market development?

    To this end, the development department should actively communicate with the company's expert consultants and propose to organize relevant departments of the company to conduct demonstration when necessary.

    After passing the first four steps, the development department will draft the new product proposal and submit it to the general manager.

Three,

    After the proposal is approved by the general manager, the project will be set up.

    At this stage, the responsibility of the Development Department is to coordinate the relationship between the cooperative development units of new products, and the specific affairs are as follows:

    1. Contract.

    2. Advance payment.

    3. Supervised the provision of relevant samples and other matters related to new drug application.

4. Preclinical studies

    The new drugs that have been qualified after the basic improvement of the prescription in the pilot test are entered into the preclinical study.At this stage, the specific business of the development department is to do all related projects except human trials with the cooperative units.Such as: physics and chemistry, pharmacology, toxicology and so on.

Clinical research

    New products qualified for preclinical study enter clinical study period.The main task at this stage is to carry out comprehensive research on the bioavailability, blood drug concentration, metabolic pathway and clinical treatment effect of the new product in accordance with relevant national regulations and designated clinical research hospitals.

6. New drug application

    New drugs qualified for clinical studies shall enter the new drug application period according to the new drug grade of the new product and the requirements of the SDA for new drug approval.At this stage, the focus of the development department is to improve the data of new drug application and approval, and urge relevant departments to handle relevant procedures as soon as possible, until the new drug certificate is obtained.

7. Approve the application for document number

    After the new product gets the certificate of new drug, the focus of the development department at this stage is to apply for approval number.The specific business is as follows:

    1. Apply for relevant forms.

    2. Instruct the process laboratory and production department to further improve the process and lay a good foundation for the next pilot test.

    3, urge relevant departments to handle the approval number.

8. ADR monitoring

    After the official production of the new product with the approval number, the focus of the development department will enter the ADR monitoring period.At this stage, the development department should cooperate with the customer service department of the company to make timely statistics and report the adverse reactions in the use of new products.Communicate with national ADR management department regularly, set up ADR files for new products, and establish a foundation for new product improvement.

Ix. Process improvement and prescription improvement

According to the ADR monitoring results of new products and the latest developments of medical research, the development Department has the right to propose improved process and improved prescription for new products already on the market.


                                           Amity Pharmaceutical Co. LTD


                                           May 18, 2001

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New Drugs Development Application Plan

A new immunological preparation for children - Edyltron (Pinotimod) dispersible tablets

Product design and research

  1. The design idea of Ed Er Qiang

    1. Customer - 0- 12 years old children

There are more than 300 million children aged 0-12 in China, and about 100 million urban children

    1. Customer needs

-- Children aged 0-12 are vulnerable to colds and other bacterial infections.

          -- Easy to take

          -- Good taste and good color (because children have a bitter feeling for white, bright colors can distract children's attention and bring beautiful associations)

    1. The product forms a complementary relationship with the newly listed Aderkang, as an adjuvant therapy for children, the four major diseases of children can be taken, but also for the next development of cough, diarrhea and other new drugs pave the way.Strategically speaking, this new product development is an old market, and there is little risk of market development by increasing the usage.

    2. Design ideas for new products

      1. The general name of the product - Pinomod

      2. Easy to take design - dosage form: dispersive tablet, oral liquid, dry suspended syrup

      3. Product specification??Mm mg (approved for children)

      4. Product channels -- hospitals, clinics (through RX sales)

    3. New product design considerations:

      1. Has Pinomod been approved for?This is the basis on which the product is decided, and of course it can be designed according to other prescriptions.


Original Files Download:

LSC0010CN_New Drugs Development Application Plan

LSC0010EN_New Drugs Development Application Plan

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More work on the R&D of Dispersible Pseudoephedrine Hydrochloride Compound Tablets

Interaction between main drug and excipient

Due to the small amount of newly added colorant and aromatic agent, we adopt the main drug: excipient =20: (the main drug is acetaminophen, pseudoephedrine hydrochloride, chlorpheniramine maleate mixed in the prescribed proportion, the auxiliary material is colorant, aromatic agent mixed in proportion), take a certain amount, according to the experimental method of influencing factors in the guiding principles of drug stability test, The drug was placed in high light (4500±500LX), high temperature (60℃) and high humidity (90±5% relative humidity) for 10 days. HPLC was used to check the content and the changes of related substances before and after placing, and observe the changes of appearance and color and other drug properties.In addition, we conducted parallel control experiments with pure raw materials to distinguish between the change of raw materials themselves and the influence of auxiliary materials.Main drug: excipients = 20:1 Chromatogram: 0 days, strong light 10 days, high temperature 10 days, high humidity 10 days and raw materials: 0 days, strong light 10 days, high temperature 10 days, high humidity 10 days altogether 8 chromatogram.

Humidity: saturated NaCl solution (15.5 ~ 60℃, relative humidity 75±1%)

KNO3Saturated solution (25℃, relative humidity 92.5%)

NaNO2Saturated solution (25 ~ 40℃, relative humidity 64 ~ 61.5%)

  1. Quality study related to substance inspection

    1. Methods HPLC was used

    2. System suitability test and content determination

    3. Destructive experiment

This experiment has been investigated in the original quality research work, and it has been proved that the degradation products and components of the three main drugs can be effectively separated and the separation degree is good after being destroyed by strong light (because the influence factor test shows that the drug is not stable to strong light).

    1. Minimum detection

Because the amount of acetaminophen in the main drug component of this drug is larger than that of the other two main drugs, we chose acetaminophen as the evaluation index.

Precise weighing of acetaminophen reference products were made into each 1mL containing 0.8mg (impurity limit 0.025%), 0.4mg (impurity limit 0.0125%), 0.2mg (impurity limit 0.00625%), 0.02mg (impurity limit 0.000625%) solution, as the test liquid.5mL of each test solution was measured and injected into the liquid chromatograph, and the chromatogram was recorded.At that concentration, the peak height of the main component of the product was observed to be 3 times the baseline noise, and the concentration multiplied by 5ml was the minimum detection limit.(With 1 photo)

    1. Determination method

Take this product, grind it, weigh it accurately and take appropriate amount of fine powder (approximately equivalent to 80mg paracetamol), place it in 25ml measuring bottle, add mobile phase and appropriate amount of shaking to dissolve, dilute to scale, shake well and filter, and take filtrate as test solution.Inject 5μ L of each solution into the liquid chromatograph with precision, and record the total area of impurity peaks in the solution of the test sample compared with the area of each peak, which should not be greater than 2% of the total area of the main drug peak and impurity peak.


In addition, the stability test still needs to provide 22 maps (note that the peak area with a retention time of about 2 minutes should be printed out).

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Some suggestions on modifying prescription and quality standard of Dispersible Pseudoephedrine Hydrochloride Compound Tablets (2002)

1. Some considerations on prescription selection and design

☆ In principle, except for the type and dosage of taste correction agent (sucrose, saccharin sodium), the type and quantity of other auxiliary materials shall not be changed, and the sum of the changed quantity shall not exceed 5%.

Because the original "the guiding principle of the new drug the supplement" (see attachment), if the material change sum not greater than 5% (including add, delete, taste masking agent or use other pigments, pigment taste masking agent replacement), basic can think obvious influence on product quality and performance may not change, declare data requires simple;If the total change of all excipients is more than 10% (including the change of excipients), it can be considered that the quality and performance of the product may have a significant impact on the change, the application data are more requirements, and even need to do the bioavailability equivalent experiment.

  • The choice of flavoring agent

At present, glycoprotein, citric acid and fresh creamer are used as flavoring agents. There should be a screening process of flavoring agent type and dosage.The application of fresh creamer similar to Guozhen seems to be restricted by the state and is not recommended.

  • Citric acid dosage selection

Due to the addition of citric acid can influence of the PH value of the products, which would influence the stability of the products, deal with its dosage (0, 1%, 2%, 3%, according to the prescribed amount) for inspection, the main indicators for traits (taste), content and related substances (attached map 4), both taste, stability, finally determine the final dosage of the drug.

  • The choice of the amount of essence

Crystal modified prescriptions used milk, do not belong to the essence, consider milk may have constraints, suggested that selects the essence of taste masking, the product prescription of the medicine is mainly for the bitter taste, smell, can choose chocolate aroma, masking and correct mint added sweeteners, also can consider to water-soluble lemon essence, but the choice of type, dosage should be according to the experiment.

  • Colorant selection

  • Provide the source of raw materials and quality standard number

Finalize the final prescription of the drug


  1. Some suggestions for quality research work

☆ Negative interference in content determination

Positive control (3 main drugs were prepared in proportion), negative control (all excipients except 3 main drugs were prepared in proportion) and sample content determination were investigated to determine whether excipients interfered with the method. 3 maps should be attached.For specific methods, please refer to Page 2 of no.7.

If there is no interference, the recovery rate should be tested again to determine the feasibility of the method.

  • Other inspection items should be tested in 3 batches according to the original standard, and atlas or data should be attached.

  • Investigation of dissolution degree

Although the original quality standard has not been established after investigation, the change of auxiliary materials should be determined after investigation whether it has an impact on dissolution and how much impact it has. For specific methods, refer to the test data and literature data of dissolution degree attached to no. 10 data.


  1. Stability study data

Three batches of samples need to be inspected, packaged in the market, and tested for accelerated stability (40℃, RH75%) respectively.

June (Assessment time 0, 1, 2, March, June;Assessment indicators: character, disintegration, content determination, related substances) and room temperature samples for 1 year (assessment time 0, 3, 6, 9, 12 months;Assessment indicators: characters, disintegration, content determination, related substances), a total of 3×5×2=30 maps are required.

Note: Determination of relevant substances has been included in the chromatogram.


Attached: Excerpt of guidelines for supplementary Application of new Drugs (chemicals)

2. Revise the prescription of preparation
    The change of preparation prescription includes the change of excipient proportion, specification and type.The newly used excipients should not interact with the main drug, not affect the inspection and determination of the quality standards of the preparation, not affect the pharmacokinetic behavior in vivo, not reduce the efficacy of the product, and not cause new safety problems.
    In view of the large number of dosage forms, the technical requirements for prescription changes in all dosage forms are not listed here.This article mainly discusses oral solid preparation.When the prescription of other preparations is changed, the relevant requirements of this article can be referred to, and according to the characteristics of the preparations, the problems and causes of the original prescription can be explained in detail, and the screening data, quality research data and stability test data of the new prescription can be provided. Pharmacological toxicology test and clinical study should be considered when necessary.
    2.1 Changes that may not significantly affect product quality and performance
    According to the prescription weight percentage, the change range of filler is ±5%, the change range of starch in disintegrant is ±3%, the change range of other is ±1%, the change range of film coating is ±1%, and the total change of all excipients should not be more than 5%.
    Add, delete pigment, taste correction agent or use other pigment, taste correction agent substitute, also belong to this category.The function and characteristics of newly used pigment and taste correction agent should be consistent with the original substance, and should meet the requirements of medicinal use, and should not interfere with the inspection of quality standards.
    The self-test report of three batches of samples and experimental data of influencing factors should be provided.
    2.2 Changes that may affect product quality and performance.
    According to the prescription weight percentage, the change range of filler is ±10%, the change range of starch in disintegrant is ±6%, the change range of other is ±2%, the change range of film coating is ±2%, and the total change of excipients should not be more than 10%.Such changes include changes in the grade of accessories and/or specifications (the type of accessories is not changed).It also includes the change of non-release control excipients, but this change does not cause significant change of drug release rate and mode.
    Detailed prescription screening information should be provided.The sample dissolution curve should be consistent before and after the change of ordinary preparation.The dissolution curves of the samples before and after the change should be compared in three different media. The dissolution media can be water, 0.1N HCl, pH4.5 and pH 6.8 buffer according to pharmacopoeia.The delayed release preparation should be compared with the dissolution curves of the samples in 0.1N HCl (2 h) before and after the change, followed by a PH4.5-7.5 buffer.3 months accelerated test data for three batches of products should be provided.Provide three batches of sample self-inspection report and provincial inspection report.
    Such changes do not require human bioequivalence tests for drugs that treat index width.For drugs with narrow therapeutic indices (see Appendix 3 for details), experimental data on single-dose bioequivalence in humans should be provided;An exemption from the bioequivalence test may be applied if an established in vitro or in vivo association exists.If the experimental results show that the product is not bioequivalent before and after the prescription change, clinical trials should be considered.
    2.3 Changes that have significant impact on product quality and performance
    According to the weight percentage of the prescription, the change of auxiliary materials such as filler agent and disintegrating agent exceeds the scope specified in 2.2, and the total change of auxiliary materials is more than 10%.This change includes the change of excipients for drug release control.
    Detailed prescription screening information should be provided.The quality study should be re-conducted and the dissolution or release curves of the drug preparation should be consistent before and after the change.If a new impurity appears after a prescription change, the toxicity of the impurity should be studied to determine whether the safety of the product is acceptable.Three batches of products should be provided with 6-month accelerated test and room temperature retention sample data. For products with good stability, the expiry date can be determined by referring to the original product.Provide three batches of sample self-inspection report and provincial inspection report.
    Experimental data on the bioequivalence of a single dose in humans should be provided.An exemption from the bioequivalence test may be applied if an established in vitro or in vivo association exists.If the experimental results show that the product is not bioequivalent before and after the prescription change, clinical trials should be conducted.

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Dispersible Pseudoephedrine Hydrochloride Compound Tablets

[Drug name]

General name: Dispersible  Pseudoephedrine  Hydrochloride   Compound   Tablets

Product name: Aiderkang

Dispersible Pseudoephedrine Hydrochloride Compound Tablets

Shuangpu Weima Fensan Pian

This product is a compound preparation, its components are: acetaminophen, pseudoephedrine hydrochloride and chlorpheniramine maleate.

This product is white tablet

[Pharmacology toxicology] Acetaminophen in this product is antipyretic analgesic, pseudoephedrine hydrochloride has the effect of selective contraction of upper respiratory tract blood vessels, chlorphenamine maleate is antihistamine.The synergistic effect of pseudoephedrine hydrochloride and chlorpheniramine maleate enhanced the effect of bronchial smooth muscle relaxation and airway resistance reduction.Can improve cold symptoms.

[Pharmacokinetics] The plasma concentrations of acetaminophen, pseudoephedrine and chlorpheniramine maleate at different times after oral absorption were plotted as a time curve.In order to AUC0—tThe average relative bioavailability of acetaminophen, pseudoephedrine and chlorpheniramine maleate was 95.5±9.5%, 106.6±18.5% and 97.4±22.4%, respectively.

This product is used to treat various symptoms caused by a cold;Fever, headache, arthralgia, sneezing, runny nose, stuffy nose, etc.

[Usage and Dosage] Take orally or disperse with warm water.Children: 2 tablets for ages 2 to 5, 4 tablets for ages 6 to 11;Adults 4 -- 8 tablets each time, 3 -- 4 times a day, the interval of 4 -- 6 hours, children under 2 years old to follow the doctor's advice.

[Adverse reactions] dry mouth, drowsiness and dizziness may occur, which can be recovered by itself after drug withdrawal.

People who are allergic to this product are not allowed.

[Precautions]

1, pregnant women, lactating women and heart disease, hypertension, hyperthyroidism, diabetes, glaucoma, emphysema, prostatic hypertrophy with dysuria and other patients should not take this product.

2. Avoid taking blood pressure medications, antidepressants or alcohol at the same time.

3. People driving motor vehicles or operating machines should not take this product.

Although animal experiments have shown no effect on embryos, pregnant women and lactating women should follow the doctor's advice.

Children under two years of age follow doctor's advice.

[Medication for elderly patients] The dosage and duration of this product shall be adjusted under the guidance of physicians according to the situation.

[Drug interaction] This product enhances the hypoglycemic effect of mesulbulurea and is easy to cause hypoglycemia.

Overdose may cause nausea, vomiting, and occasionally allergic reactions, such as rash, fever, and mucous membrane damage.

Each tablet contains acetaminophen 80mg, pseudoephedrine hydrochloride 7.5mg, chlorpheniramine maleate 0.5mg.

[Storage] Shading, airtight, stored in a cool and dry place.

Package: 12 pieces x 1 plate/box, double aluminum plastic packaging.

[Effective period] tentative two years

[Approval Number]

[Production unit]

Company name: Shanxi Aid Pharmaceutical Co., LTD

Mail editor: 048000

Address: Jincheng Economic and Technological Development Zone

The telephone number is 0356-2122534

Fax number: 0356-2122534

Web site: http://www.aidphar.com

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Beijing **** Children's Pharmaceutical Research InstituteBusiness Plan (Draft 2002)

 Combined with the actual situation of children's drug use, this paper puts forward the medium and long term operation plan of Beijing First Medical Aid Children's Drug Research Institute, please review in advance.

I. Business direction and strategy

      The pharmaceutical industry is an industry with high risk, high income, high technology and high return. At present, there is not a research institute specializing in the research and development of children's drugs in China.We in professional field, will produce good benefit, at the same time due to drug development needs huge investment, the first medical Ed medicines for children research institute is just starting, advice from the first application technology development started to make the transition to technology innovation, medical basic research, finally established the world's leading position, the main reasons are as follows: At present, the lack of dosage forms of children's drugs restricts clinical application and wastes drug resources.Medication for children is common for adults.There is no research and development of children's medicine in China.From the technology application to start with less investment, lower risk, quick effect, easy to the initial accumulation of capital.

Second, the management

      According to the modern enterprise system to form a capable organization team, the implementation of the project manager responsibility system, responsible for profits and losses.We will give full play to the enthusiasm of researchers.

  1. Organizational structure:……

    Original Files Download:

    MAN0005CN_Beijing CMU-AID Pharmaceutical Institiue Business Plan(2002)

    MAN0005CN_Beijing CMU-AID Pharmaceutical Institiue Business Plan(2002)

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Jiuerxin capsule

Product description of Aizhuerxin Capsule

   (I) Product introduction

[Prescription] Panax notoginseng 134G Chuanxiong 335g Danshen 67g

        Safflower 134g Alisma alisma 67g Acanthopanax senticosus plus extract powder 31g

    [Method] The above six flavors, 37 crushed into fine powder, sieve;The volatile oil was extracted from ligusticum chuanxiong, and the distilled aqueous solution was collected by another device.Liquid and safflower, salvia miltiorrhiza, alisma, add water decoction twice, the first 3 hours, the second 2 hours, merging decoction, filtration, the filtrate and the distillation of aqueous solution to merge, condensed into concrete, drying, crushing, and notoginseng powder, acanthopanax extract powder blending, injection rhizoma ligustici wallichii volatile oil, blending, seal for 2 hours, encapsule, made 500 grains, quick.

   [Properties] This product is capsule, the content is brownish yellow, fragrant, bitter, astringent after sweet.

    (1) Take the content of this product about 0.5g, add 10ml ethanol, heat reflux for 30 minutes, cool, filter, take 2ml filtrate, add sodium nitrite solution (1 20) 0.3ml and 10% aluminum nitrate solution 0.3ml, shake well, place for 3 minutes, add sodium hydroxide solution (0.1mol/L) 2ml, that is, reddish brown.

   (2) Take 1g of the content of this product, add petroleum ether (60~90℃) 10ml, soak for 6 hours, shake constantly, filter, take 1ml of filtrate, steam dry, residue add 1ml methanol to dissolve, add 2~3 drops of 2% nitrobenzoic acid methanol solution and 2 drops of potassium hydroxide saturated methanol solution, purple red.

   (3) the contents about 2 g amount of this product, methanol 20 ml, dipping 30 minutes, all the vibration wave, filtration, the filtrate zhenggan 10 ml of water dissolution, filtration, the filtrate extracted with ether twice, each time 10 ml, abandon to ether liquid, reoccupy n-butyl alcohol extract three times, each time 5 ml, combination of n-butyl alcohol extract, boiled, add 1 ml methanol dissolved, greatly as the solution.Let's take 37 R1, methanol was added to prepare a solution containing 2.5mg per 1mL as the reference solution.According to thin layer chromatography (Page 57 of Appendix), 5μ L of the above two solutions were absorbed, respectively, on the same silica gel G thin layer plate, the upper solution of N-butanol-ethyl acetate water (4-1:5) was used as the developing agent, unfolded, dried, and sprayed with sulfuric acid solution (1 10), at 105℃ for about 10 minutes.In the chromatogram of the tested substance, spots of the same color appeared at the corresponding position of the chromatogram of the reference substance.

    (4) take 0.5g of the content of the product, add anhydrous ethanol to reflux for 30 minutes, cool, filter, take 2ml of filtrate, put in a 25ml measuring cup, add anhydrous ethanol to the scale, spectrophotometry (appendix 51 page) determination, the maximum absorption at 281nm wavelength.

   [Inspection] It should comply with the relevant provisions under the capsule item (Appendix 16 page).

   [Functions and Indications] Invigorate blood circulation, remove blood stasis and give birth to new life.For coronary heart disease, gelatinous pain.

   [Usage and Dosage] Take orally, 2-4 tablets at a time, 3 times a day.

   [Specification] 0.45g per tablet.

   Storage To seal.

Acanthopanax extractives powder is acanthopanax extractives (p. 458), dried and crushed.

   [Precautions] This product is not suitable for blood deficiency without blood stasis, pregnant women should use with caution.


Original Files Download:

LSC0006_CN_Aidphar_Jiuerxin Capsule

LSC0006_EN_Aidphar_Jiuerxin Capsule

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A brief introduction to the Folide Project (1999)

I. Project name, construction unit and location: 6

1. Project name: Folide

2. Construction unit: Shanxi Qifanshan Pharmaceutical Co., LTD

3. Construction site: 1 Xinhua Street, Gaoping City, Shanxi Province

Ii. Market Situation:

1. Main uses and application fields of the product:

1. The main use of Freid tablets: antitussive and expectorant.

2. Applicable scope: acute and chronic bronchitis, pneumonia, tuberculosis, pharyngitis and cough and expectoration caused by cold, facing a broad consumer group of all ages and all income levels.

2. Comparison of like products:

① Compared with Traditional Chinese medicine: symptomatic treatment, accurate efficacy, accurate dose and wide application.

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LSC0005_CN_Qifoshan_Folide_Project Introduction

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Introduction of Shanxi Qifanshan Pharmaceutical Co., LTD (1999)

Shanxi Seven Foshan pharmaceutical Co., Ltd. is a set of production, development, marketing as one of the modern new pharmaceutical enterprises, is located in the southeast of Shanxi Province. In history, the famous "Changping Battle" in Gaoping city, the ancestors of the Chinese nation - Yandi, Yandi ling is 10 kilometers away from the city. (According to the research is earlier than the Yandi Mausoleum in Hunan province, central Radio 2 reported). Only two hours away from Zhengzhou International Airport, convenient transportation, advantageous geographical location. Gaoping city is one of the key coal-producing city in China, known as the "coal and smelting of the township" reputation, coal smelting industry has always been the city's main economic pillar, along with our country's reform and opening- up and the establishment of the socialist market economy, the single product structure, low content of science and technology, single industrial structure of resource-based economy too influenced by the market, more and more not adapt to the request of the construction of economic city. In 1996, the municipal party Committee and the municipal government made a strategic decision to adjust the industrial structure and set up seven Foshan Pharmaceutical Co., LTD.

Since the establishment, leaders of governments at all levels give high attention and key support. Wu Jieping, vice chairman of the National People's Congress, inscribed the name of the company; Zhang Wenkang, minister of the Ministry of Health, who is busy with his work, gave encouragement with the inscription "serve the people's health and serve the modernization construction". Provincial party committee and provincial government leaders visited the company for many times. The leadership's concern and support greatly encouraged all the staff.

At present, the first phase of solid preparation workshop of Foshan Pharmaceutical Company has been put into operation in December 1998. The workshop is designed and built according to the national GMP standard, with an annual production capacity of one billion tablets. The liquid preparation workshop will be purified and put into operation in 2000. The company has 143 employees, 30% of whom have college education or above, and 100% of the greening and hardening area of the factory.

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LSC0004_CN_Qifoshan_Pharmaceutical_Company Brochure

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Folide Integrated Marketing Promotion Strategy (1999)

I. Strategic issues and opportunities:1. Marketing environmentProblem point: western medicine cough more without a high brand name;National drug classification management affects channel selection and poor brand image.Opportunity point: Facing the coming OTC market consumption, it provides an opportunity to establish the Folide brand. 2. Buyer status Problem: Folide is a new drug on the market and the market has just started. Consumers are not aware of the harm of addiction and are not familiar with the concept of codeine, so the purchase rate is low. Opportunity point: The efficacy of Folide is small (special formula), safe and convenient, to meet the needs of consumers. 3. Product statusProblem point: high degree of homogeneity Opportunity: Formula features: cough and expectorant, good synergis-tic effect, codeine-free, no addiction, small side effects, safe and conve-nient (OTC). 4. Competitive situationProblem: Lizhu carle, can dimei positioning, slightly stronger function, Shanghai Meiyu capsule, product growth will face the resistance of traditional Chinese medicine and the above three drugs. Opportunities: poor brand image, not outstanding and not containing codeine, provides opportunities for Friede brand positioning. 5. Propagation conditionsProblem points: Kangbei kexing film's perceptual guidance rational appeal, new features;Juzhi syrup highlights four major functions, which affect the spread (surface) of Frede to a certain extent.Opportunities: Strive for innovation and integrated communication. TV ads only make functional appeals;Brand image advertising. SP strengthens terminal promotion and strengthens thrust……

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LSC0003_CN_Qifoshan_Pharmaceutical_Folide_Promotion_Startegy

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Long-Term Development Strategy of Qifoshan Pharmaceutical (1999)

The development strategy is a programmatic document that guides the development of the company. To formulate it, you must be familiar withthe international and domestic macroeconomic situation; you must understand the national industry guidance policy; and it must be based on a fullinvestigation of the market. Especially for my country's pharmaceutical industry market, the policy is relatively familiar. Seven Foshan Pharmaceutical'sPlanning Department has been conducting a survey of second-hand data since March 1998, and has looked up a lot of valuable data. At the same time, I visited the company's advisory committee, combined with the market research conducted in recent months, and considered the company's developmentneeds. A preliminary development strategy report was prepared and submitted to the company’s board of directors for review and recommendations.

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LSC0002_CN_Qifoshan_Pharmaceutical_Long_Term_Strategy

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Investment Study on Qifoshan Pharmaceutical (1999)

###### Co., Ltd. is a well-known listed coal chemical company in the country.

By optimizing the capital mix and adjusting the product structure, the two pillar industries of coal and chemical have been formed a good performance. As Chinese participation in WTO approaches, ## Company will be facing more tense domestic and international markets competition. As a coal-based listed company, from the perspective of sustainable development analysis, it is believed that coal companies Industry investment volume is high, Whereas capital turnover is slow, and resources are depleted; at the same time, nuclear energy, water energy, and natural gas

Increased competition for resources. Therefore, ## company must be adjusted as soon as possible from a strategic point of view: advance to the high-tech direction

The company, on the path of sustainable development, is looking for new economic growth points. The company changed its name in 1999 as "###### Co., Ltd." which indicates that ## has taken an important step in strategic adjustment.

In 1999, ## actively explores to find new economic growth points and prepares to invest in Qifoshan Pharmaceutical Co., Ltd., involved in the pharmaceutical industry.

The pharmaceutical industry is a sunrise industry in the past century. As long as people’s lives never stop, there are people and illnesses

There is also a market demand for disease. From the perspective of sustainable development, the pharmaceutical market is considered to be a huge potential.

The current medical industry is a high-tech, high-investment, high-risk, and high-return business. Qifoshan Pharmaceutical is a pharmaceutical company with a scale production volume in the city, with completed hardware and equipments, in line with GMP design requirements

For Qifoshan Pharmaceutical, the product structure is reasonable, the market potential is large, but the liquidity is scarce, ## and Qifoshan Pharmaceutical can make up for each other to make use of its own advantages and explore a new path for ## to find new economic growth points.

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