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Contents Brief Introduction of Aburaihan Company

Organization Policy

Organization Chart

Qualified Human Resource

Production Department

Engineering Department

Sanitation and Environment Protection

Documentation

Quality Assurance Department

Quality Control Department

R & D Department

Marketing Department

Sales & Export

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GENERAL INFORMATION ON THE MANUFACTURER

* Contact information on the manufacturer

Aburaihan Pharmaceutical Co.

No.1 Hojrebne Oday Avenue, Tehran pars Crossroads, Tehran, I.R.IRAN

P.O. Box 16765-1568

Tehran, Iran

24 hour contact Telephone No: 77 70 71 73-6 & 77 88 23 57

Fax No.: 77702066

E-mail address: info@aburaihan.com

URL Address: www.aburaihan.com

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Brief Introduction of Aburaihan Co. Aburaihan Pharmaceutical Company is one of the major

manufacturers of human and veterinary products in

I.R.Iran.

Owing to its more than 48 years experience, it plays a great

role in the improvement of pharmaceutical industry in

I.R.Iran.

Aburaihan Pharmaceutical Company was established in

1965 under the ownership of the German Schering

Company named "Berlimed of I.R.Iran". In 1981, the

Company renamed as " Aburaihan Pharmaceutical

Company” (Private joint-stock), and finally turned into

public joint-stock Company in 1981.

Aburaihan has the manufacturing license of medicinal

products from the ministry of Health in I.R.Iran. Also,

some products are being manufactured under the license of

some other European Pharmaceutical Companies.

The pharmaceutical products of Aburaihan are categorized in two main categories:

• Human products

• Veterinary products

Aburaihan Pharmaceutical Company in order to produce is Human and Veterinary

products, along with supplying raw materials from reputable manufacturers and the

exact consideration of cGMP laws and WHO standards for manufacturing and

controlling medicine, as well as based on USP, BP, and EP international standards

produce the best medicine products with desirable clinical effectiveness.

The management of Aburaihan Pharmaceutical Co. announces itself commitment to

integration management systems (IMS) in its policy and also emphasize on customer

satisfaction, the company order to the managers of units to transfer this important

matter to their personnel.

Integrated Management System (IMS) at Aburaihan Pharmaceutical Company is based

on International Standards ISO 9001:2000 (Quality Management), ISO 14001:2004

(Environment Management) and OHSAS 18001 (Occupational Health and Safety

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Management System) which is established with related certificate from RWTÜV of

Germany.

► ISO 9001:2008 Certificate from RWTÜV CERT

Certificate No.: 44100 085785

► ISO 14001:2004 Certificate from RWTÜV CERT

Certificate No.: 44104 085785

► OHSAS 18001:2007 Certificate from RWTÜV CERT

Certificate No.: 04116 050321

► Integrated Management System (IMS) Certificate from RWTÜV system GMBH

Certificates No.: 44100 085785

44104 085785

04116 050321

Quality Risk Management (QRM) This company has the Quality Risk Management system which is a process for the

assessment, control, communication, and review of risks to the quality of the drug

product across the product lifecycle.

Risk managements activities are performed by some experts from Production, Technical

& Engineering, QC and QA department.

PREMISES AND EQUIPMENT

Factory: 9850 m2

Production areas: 5927 m2

Warehouses: 1651 m2

Utilities and servicing areas: 4235 m2

Aburaihan Pharmaceutical Company is

subgroup of Daroupakhsh Holding Co. and

Daroupakhsh Holding Co. is working under

guard of TPICO (Tamin Pharmaceutical

Investment Company).

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Organization Policy Aburaihan Pharmaceutical Company in order to achieve its goals and enhance quality

and customer orientation, environment maintenance and also providing Health and

Safety for the society pay attention to the following cases to follow the all cGMP

regulations and also incorporating Integrated Management System (IMS) based on

international standards including ISO 9001-2008, ISO 14001-2004 OHSAS 18001-2007.

1. General and constant effort to access the defined goals for products, activities and

organizational services leading up to attract domestic and foreign customer's

satisfaction and continued improvement.

2. Ensure the implementation of all regulations of cGMP for all production process.

3. Achievement of Quality goals, development of variety and to increase value of

products with maintenance of product qualification.

4. To improve executive methods and use of suitable production equipments in order to

maintain and enhance products qualification and increase the benefits.

5. Entering to foreign markets to show products.

6. Creating suitable background for performing team work, to raise sharing of

motivation and technical knowledge for personnel to access the company's goals.

7. Carrying out all activities based on state, country's laws and regulations, and written

laws in ABURAIHAN Pharmaceutical Company.

8. Implementation of Environmental Management Systems in order to prevent the

pollution with respect to National and International Standards.

9. Environmental protection in respect of society & considering to the sustainable

development

10. Optimal Consumption Management of energy & resource as environmentally friendly

industry.

11. Performing Occupational health and safety management systems with respect to

Occupational health and safety regulations to reduce risks and hazards.

It's necessary that all company's managers inform their subdivision colleagues and

personnel, contractors and other interested groups about the written company's policy.

They determine require, targets to defined framework of policy and practical methods in

order to their objectives.

Management's representative Dr. Abdolreza Soleimanifar

Managing Director Dr. Akbar Mansouri

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Organization Chart

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Qualified Human Resource Aburaihan Pharmaceutical Company with a

knowing and choosing perspective has

employed experience, responsible and obligate

personnel for its long term goals. This

company has started its activities with 90

personnel in 1970. At present, the company has

414 employees that they are working to

improve company's goals and activities.

Company's scientific staff are consist of 115

experts, 2 Physicians, 3 Veterinaries and 12

pharmacist that they are doing their activities based on expertise, obliged and foresight.

Training The employee training curriculum is based on the job functions and responsibilities.

Employees will be trained by the quality assurance and training departments, head of the

departments, and experts who have drafted the procedures and guidelines. Professional

development, GMP and ISO training sessions are conducted by the consultants and

reputable training organizations.

The employee training curriculum will be controlled and monitored by the Human

Resource Management and training departments. Classroom training sessions will be

conducted when there is a new procedure or the documents have been revised. The new

procedure or revisions will be screened by the quality assurance department for version

controls and compliance to the internal standards and other external ISO and GMP

standards.

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Production Department Aburaihan Pharmaceutical Company's products are divided to two types of Human and

Veterinary products.

Human's medicine is consist of solid products (types of uncoated tablets, film coated

tablets and capsules); Injection (types of water base and oil base ampoules and vials,

suspensions and some lyophilized products which will be added as soon as possible),

Semi-Solid products (types of Suppositories, Ointments, Cream and Gel).

Veterinary products department started in 1991 and now this department produces 29

numbers of Veterinary products that will be added 4 new medicines to other products in

2012. There are 3 parts in this department such as Ointment, Cream and Sterile Injection

products.

The plant is designed to produce oral solid dosage forms as well as Ointments, Creams,

Suppositories and Sterile Injectable products.

The general production stages of each product group are:

• Receipt of raw materials and sampling

• Interim storage of raw materials

• Weighing

• Manufacturing

• Packaging

• Storage of finished product

• Distribute

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When the batches are finished, they will

be transferred to the warehouse and will

be stored until there is an order for these

products. The status of all products in the

warehouse is indicated by the computer

generated labels of on-hold, under-

testing, rejected and released products.

When the batches are finished, they will be

transferred to the warehouse and will be

stored until there is an order for these

products. The status of all products in the

warehouse is indicated by the computer

generated labels of on-hold, under-testing,

rejected and released products.

Sterile products are manufactured and

packaged in separate and enclosed areas and

under supervision of qualified persons

trained in microbiology. The classification of

production rooms are based on grade A, B,

C, and D as follows:

Formulation of products takes place in an

environmental where a minimum of grade C

condition is maintained. Parenteral products

are filled in an aseptic area with at least a

grade B environment. Non-parenteral are filled in a grade C environment before

terminal sterilization. At Aburaihan Pharmaceutical Company Human's injectable

medicine department is consist of two section, Oily Sterile production and Aqueous

Sterile production.

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Production Output Aburaihan Pharmaceutical Company's production department will determine its rate of

production based on society's demand and its undertakings in relation to public health.

The following is Aburaihan's production capability in a year:

Product Category Standard Capacity; No. Year (million)

Ampoule 36

Tablet (All Types) 1400

Capsule 100

Cream / Ointment / Gel 15

Suppository 180

Veterinary Product 5

Grand Total 1.736

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Engineering Department The engineering department is responsible for maintenance and servicing of all machines

and instruments used in the production lines.

Sanitation and Environment production The hygiene program at Aburaihan encompasses the clothing requirements, all personnel

and visitors who have access to the manufacturing, laboratories, and warehouse areas.

Personnel who work in the sterile areas undergo special gowning and sanitation

trainings.

The hazardous and toxic materials such as Hormones and Steroids materials are stored

in a special area in the raw material warehouse. Other sensitive materials are in he

warehouse under room temperature or refrigerated depending on the storage condition

of materials received in the warehouse. The material safety data sheets are available for

all products.

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Documentation Production of all pharmaceuticals is done as per the Master Production Documents, Data

sheets for in-process testing and checks, and SOP’s. Master production records includes

the specification for raw material, packaging material, packaged dosage form, master

formula, sampling procedure and critical processing related SOPs. All these documents

are cross referenced and linked in order to have better control over the production

process and activates. All GMP documents are reviewed and maintained as per the

GMP requirements. The production batch records have cover sheets in which describes

what kind of documents should be in the batch records. Electronic copies of all

documents are stored in the computer data base. Equipment specifications are kept with

the machines and controlled by the production, engineering, and quality assurance

departments. Specifications for disposables and cleaning materials are kept in the

production and quality control areas. The original copies of all standard operating

procedures are kept in the quality assurance department and controlled copies are sent to

the production, warehouse, and laboratory areas.

Quality Assurance Department The Quality Assurance department is controlling all aspects of manufacturing through

the quality systems such as Product Certifications, complaint and recalls management,

Self- inspection and Internal Audits, and change control. For all these systems qualified

individuals are organizing the quality meetings to assess the product releases/rejects,

complaints and recalls, and changes in the production lines and procedures.

Quality Control Department The Quality Control department at

Aburaihan is consists of Analytical,

Microbiological, precision instrumentation,

and In-Process testing unit. All chemical,

microbiological, and physical testing of raw

materials, In-Process material, and finished

products are done as per the in-house

methods and/or other standards, such as

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USP, other pharmacopeias depending on the products. The analytical lab is equipped

with very sophisticated instrument such as HPLC, GC, FTIR, KF, and TOC.

The In-Process testing unit is responsible for taking sample from raw material, semi-

finished products and fully finished products for chemical and physical testing as

directed in the master production records for every product.

Sterility testing, particulate matter, and microbial testing are done in the microbiology

laboratory. The product test methods are qualified by the chemists before performing

any analysis.

Research and Develop Department The Research and Development (R&D) team at Aburaihan develops new drug

formulations to improve customer’s demand and their point of view in order to promote

the high quality products, add to existing formulations and delineate new processes using

new product adding strategy.

From pre-formulation studies to point batches and commercial scale ups with process

validation, we can also handle the entire gamut of actives leading up to finished dossier

and DMF compilation. Aburaihan Pharmaceutical Company’s R&D department for

gaining of company’s long term goals doing their activities with perfect expertise and

scientific staff that they are consist of pharmacists and chemists, use of software and

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hardware facilities resources and scientific references, documented and confirmed types

of systems and research modern equipments.

Marketing Department The company's marketing philosophy is based on customer satisfaction belief, and

through a continuing focus on strategic planning, launching technologically advanced

products & innovative marketing approach, Aburaihan is successfully extracting a

remarkable growth from year to year.

Aburaihan Pharmaceutical Company believes that customer's satisfaction and trust are

its original investment and also believes that this matter can only be accomplished

through honesty, obliged and taking responsibility. In this regard, company's marketing

unit try to reach and promote this goals.

There is service customer management in marketing development which proceeds with

company's goals through marketing planning and organization, data collection, data

analysis, marketing opportunities analysis. One of the activities of marketing unit is

holding instruction classes and several communicative-scientific seminars for inside

personnel and visitors, take part in exhibition and its scientific richness for customer

survey and service, customer retention and customer training.

Sales & Export Department Aburaihan Pharmaceutical Company is considered among the top rank pharmaceutical

manufacturing units of I.R.Iran. It holds first rank in hormone drugs in I.R.Iran. It

domestic sales increase at least 20% annually.

Aburaihan Pharmaceutical Company has emerged as an important player in the I.R.Iran

health sector by providing latest medicines of international standards for major diseases,

priced with due consideration to the end consumer.

Aburaihan Pharmaceutical Company has a network of 36 distributing center via 2 main

distributing Co., named Daroupakhsh Co. & Hejrat Co., working nationwide and

ensuring the availability of Aburaihan Pharmaceutical Company products for the ailing

humanity and having professional field force of more than 40 people to continuously

update and persuade the prescribes of I.R.Iran.

Aburaihan Pharmaceutical Company believes that the customer is the King.

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Apart from conventional exports our doors are open for. The Aburaihan Pharmaceutical Company’s products are competitive and in supply at international markets .Because the company’s raw material of products are provided from the best and most reputable resources in the world and production process controls and analyses stage by stage. At present, some of company‘s products are presented and registered is some countries such as Uzbekistan, Tajikistan, Ukraine, Afghanistan, Uganda, Iraq and etc. Aburaihan Pharmaceutical Company’s constant effort is based on qualification, honesty, service customer in order to reach more to international markets is to be continued. Customized packaging and portfolio management of products are available in exporting countries according to demographic requirements.