About Us
Bakhtar Bioshimi Pharmaceutical Company was established in 1990 in Kermanshah Province, initially covering an area of 5,000 square meters with a built space of approximately 3,000 square meters. As a leading entity in the pharmaceutical sector, the company specializes in providing advanced and innovative solutions in generic medicine, aimed at making cutting-edge medications both affordable and of the highest quality. Our mission is to enhance the quality of life through pioneering health solutions
From its inception, our manufacturing facilities have been designed and upgraded in accordance with international standards, ensuring that we remain compliant with current industry benchmarks. The production area has since expanded to over 12,000 square meters. We now operate two dedicated production lines for solid forms within a Grade D clean room, capable of producing more than 12 million units of tablets and capsules per shift. Additionally, we have established an aseptic production line for the manufacturing of sterile ophthalmic solutions.
Bakhtar Bioshimi Pharmaceutical Company, with over 35 years of dedicated experience in the pharmaceutical industry, is equipped with state-of-the-art machinery and advanced laboratory facilities. We proudly produce more than 150 finished pharmaceutical products, including tablets, capsules, and ophthalmic solutions. Our commitment to innovation drives us to develop creative and effective solutions in the realm of specialized medicines.
One of the key categories of products offered by Bakhtar Bioshimi is anti-viral medications. As the sole major manufacturer of anti-viral products in the region, the company effectively addresses all current treatment protocols for HIV, along with hepatitis B, C, and other viral infections.
Additionally, Bakhtar Bioshimi is recognized as the producer of anti-multiple sclerosis (MS) medications, within dedicated manufacturing lines for higher potency compounds.
To meet our quality objectives, Bakhtar Bioshimi Pharmaceutical Company has established a comprehensive quality management system in accordance with the principles of Good Manufacturing Practices (GMP) as outlined by the WHO, FDA, EMA, and PIC/S standards. This system empowers us to produce and deliver pharmaceutical products of the highest quality, demonstrating clinically favorable effectiveness.
We take great pride in being the first Iranian pharmaceutical manufacturer to participate in the WHO Prequalification of Medicines Program specifically for anti-HIV products. Our production facilities have undergone comprehensive inspections and evaluations by experts from the WHO.
Additionally, our company has successfully navigated numerous external audits, including an assessment conducted by Médecins Sans Frontières (Doctors Without Borders) in France, which has granted us the approval to supply the essential medicines required by their organization.
Sister Companies
Quality Control
Quality control laboratories with dedicated and dexterous staff are able to perform all tests in compliance with the latest version of pharmacopoeia and guidelines. Likewise our Laboratory management system is based on GLP regulations & standard ISO 17025: 2005.
The lab is accredited by Ministry of Health and Medical Education and awarded in 2014 from MOH. In this laboratory all of experiments regarding approval of pharmaceutical raw materials and packaging material have been carried out. In addition, Identification of each container of every consignment is made beside its approval test. The lab is equipped with the HPLC systems, GC, Karl Fischer, IR and other equipment and materials needed to perform the tests.
Culture media preparation & incubation in this laboratory are equipped with dedicated clean rooms. Microbial tests are performed on all raw materials and stages of intermediate products as well as finished product. In purposes of validations and verification, tests are applied on samples from production areas and machinery. The lab has two autoclave, incubator, colony counter and also media types and microbial strains which are needed based on international standards.
It has been one of the best equipped laboratories in our factory for monitoring the stability of our products in the long term and Accelerated condition and also retained sample. Chemical and physical tests for the approval of the stability of products have been conducted up to 1 year after the expiry date on the schedule in accordance with the standards rules.
This laboratory by using various systems will carry out experiments on potable water and all produced purified waters in the company as well as waste water before and after treatment according to international references. These tests consist of measuring conductivity, TDS, pH, hardness, heavy metals, TOC, anionic and cationic compounds and BOD/COD analysis.
In purpose of approval of chemical and physical specifications, all products (liquids and solids) are tested in intermediate and finished stages according to international references and intended specification. In case of approval by this lab, the products might pass out the production stage. Tests performed by the laboratory include all the physical tests such as hardness, disintegration time, diameter and thickness, pH, viscosity, osmolarity, density and physicochemical tests such as uniformity of dosage forms contents, dissolution tests and assays.
In this laboratory all intermediate products according to defined specification for avoidance of any deviation during production frequently tested and evaluated. Tests are performed depending on the product type. The various products are sampled and tested every 5 to 15 minutes. The samples are taken from mixing, granulation, tablet process, capsule filing, blistering, cartoning, tablet coating, and mixing and Filing of drops.
Research & Development
Is a paramount section in ensuring the future of the BB Pharmaco. This unit with recruiting qualified and experienced staffs, advanced equipment in addition providing new formulation and analyzing methods is moving forward to developing diverse high qualified products and responding the new markets. Some of the tasks in this section are mentioned below:
- 1. Formulating new products
- 2. Scale up the production processes for new products
- 3. Leading and monitoring the validation process for the manufacturing of new products
- 4. Promotion of research collaboration and technology to achieve superior technology
Providing new pharmaceutical formulations in stages including feasibility studies, scientific research in references, pre-formulation, formulation and analysis are implemented and evaluation, preparation and compilation of documents which are required to manufacturing new products are provided. In research and development, stability studies, safety and bio-equivalence assessment is also carried out. Some of the tasks in this section are mentioned below:
