The Legacy of Dr. Abidi Pharmaceuticals

Medication Quality

The quality of a manufactured medication is not limited merely to its raw materials.

Factors Influencing Medication Quality

Raw Material & Packaging

In pharmaceutical manufacturing, the quality of raw materials and packaging is of utmost importance. Raw materials comprise the Active Pharmaceutical Ingredient (API) and excipients. The API is the active component responsible for preventing, controlling, or treating a disease. Excipients are added to the API to formulate the dosage form and facilitate drug dissolution and absorption.
Material quality, packaging format, the number of units per package tailored to patient compliance, stability studies on packaging under controlled temperature and humidity conditions, and all related analytical testing are conducted to ensure the medication is packaged with the highest quality and maintains its efficacy over time.
Our standards for selecting API suppliers far exceed pharmacopeial requirements (the reference for raw material and product control), and we enforce stringent quality controls on all incoming materials.

Formulation, Manufacturing Processes, & Analysis

Our R&D team consists of seasoned experts who select cutting-edge, globally recognized medications for development. During the formulation phase, Bioequivalence studies are conducted to ensure absolute therapeutic equivalence with international branded counterparts. To enforce strict quality control, we continuously invest in modernizing our analytical laboratories.

Manufacturing Area

Utilizing appropriate materials for ceilings, floors, and walls, decontaminating environments and equipment from human or non-human factors, and optimizing equipment layout are among the measures taken to optimize the manufacturing Area. Based on the latest Good Manufacturing Practice (GMP) standards and through consultation with reputable European firms, we have renovated our manufacturing facilities and continuously maintain them in compliance with global standards.

Equipment & Utilities

Manufacturing equipment and utilities play a crucial role in producing high-quality medications. Through continuous capital investment in the newest and most advanced machinery, Dr. Abidi Pharmaceuticals consistently equips and upgrades its production lines. Furthermore, by strictly adhering to Standard Operating Procedures (SOPs) for operating and maintaining the cleanliness of these machines, we prevent potential issues during the preparation and packaging stages. Other initiatives by Dr. Abidi Pharmaceuticals to improve the production environment include:

Implementing Building Management Systems (BMS) for manufacturing areas to enable automated pressure control and reduce human error.
Strict compliance with material and personnel flow requirements.
Adherence to GMP guidelines in project design and execution.
Installation of a Pharmaceutical Water Purification System utilizing Thermo-Compression technology—the first of its kind in Iran.

Quality Assurance (QA) & Quality Control (QC)

We have implemented all QA systems in strict accordance with GMP principles. All rooms where medications are exposed must be monitored for temperature, humidity, pressure differentials, and HVAC systems, classifying them as certified “Cleanrooms.” We also guarantee quality in the design, installation, commissioning, and operation of equipment, utilities, and cleanrooms. For machinery in direct contact with medications, we utilize specific, validated cleaning procedures when switching from one product to another. At Abidi, in addition to general standards approved by the IFDA (Iran Food and Drug Administration), we benchmark our procedures against stringent international guidelines.

Human Capital

A highly motivated and proficient workforce is the key driver of quality at Dr. Abidi. We are deeply committed to investing in the continuous training of our human capital, often utilizing international consultants. Furthermore, through rigorous periodic medical examinations, we consistently safeguard their health, hygiene, and safety.

Quality Policy

Quality Certifications

Backed by over 80 years of distinguished experience, Dr. Abidi proudly holds prestigious national and international quality certifications. Each credential represents a chapter in our ongoing commitment to continuous quality monitoring and impactful investment in public health.

GMP Certificate from the Iran Food and Drug Administration (IFDA)

ISO Certifications across 5 Standards

Sanofi Approval for Under-License Manufacturing

AstraZeneca Approval for Under-License Manufacturing

Synthon Approval for the Manufacturing of Specialty Medications

Quality FAQs

1Do medications containing the exact same Active Pharmaceutical Ingredient (API) share the same quality when manufactured by different pharmaceutical companies?

No. Factors such as production facility conditions and equipment, human resources, formulation, the quality of Active Pharmaceutical Ingredients (APIs) and excipients, as well as manufacturing and packaging procedures, can all impact the quality and efficacy of medications. Therefore, recognizing that production quality varies among different pharmaceutical companies can assist patients and healthcare professionals in choosing better medications.

2What constitutes a counterfeit or fake medication, and how can one obtain high-quality medicines?

Medications that are not manufactured or imported in accordance with the regulations of the Iran Food and Drug Administration (IFDA) are considered counterfeit or smuggled. Purchasing from legal and authorized channels (pharmacies) is the safest method to obtain medications. Furthermore, at the time of purchase, attention must be paid to the presence of a 2D barcode or an authenticity label containing validation information. Dr. Abidi Pharmaceuticals is a pioneer in implementing the 2D barcode system across all its manufactured products.

3Is there a regulatory body or organization that certifies the quality of a medication?

Yes. Generally, Iran Food and Drug Administration (IFDA) under the Ministry of Health and Medical Education is the authority responsible for overseeing pharmaceutical quality. At Dr. Abidi Pharmaceuticals, alongside strict compliance with IFDA regulations, rigorous audits are conducted by inspectors from multinational pharmaceutical companies—such as Sanofi and others—to ensure the uncompromising quality of our manufactured medications.

4How can one report a medication’s lack of quality or its adverse side effects?

For any information regarding proper administration, side effects, drug interactions, and more, individuals can reach out via the contact details provided in the Patient Information Leaflet (PIL). Alternatively, these issues can be reported directly to the treating physician or the pharmacist-in-charge at the pharmacy.

Adverse Drug Reaction (ADR) Reporting

5Where are the raw materials sourced from, and how is the quality of these Active Pharmaceutical Ingredients (APIs) ensured?

Pharmaceutical raw materials are procured from reputable sources whose production lines have been previously audited and approved by representatives of the IFDA and Dr. Abidi Pharmaceuticals. These suppliers often hold GMP certifications from the U.S. FDA or European Medicines regulatory authorities. It is worth noting that before entering the manufacturing process, these materials undergo rigorous evaluation and approval by Dr. Abidi Pharmaceuticals’ Quality Control (QC) laboratories.

6Does the quality of the materials used in a medication affect the occurrence of adverse side effects?

Predominantly, a drug’s side effects stem from the inherent properties of its Active Pharmaceutical Ingredient (API). However, certain adverse reactions can arise from a failure to adhere to the eight core quality principles: facilities and workspace, equipment and machinery, human resources, Health, Safety, and Environment (HSE), materials and formulation, control and monitoring, methods and processes, as well as validation and qualification. Equipped with a robust Quality Management System (QMS), Dr. Abidi Pharmaceuticals meticulously complies with all quality principles to minimize any adverse effects associated with quality deviations.

7What standards must be observed during pharmaceutical manufacturing?

Generally, producing high-quality medications requires mandatory adherence to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and Good Storage Practices (GSP), which are formulated based on the regulations of the IFDA and international regulatory bodies. By adhering to these standards, Dr. Abidi Pharmaceuticals has successfully obtained GMP certificates for various production lines, as well as an accredited control laboratory certificate from the IFDA. Furthermore, our GMP compliance level has been audited and approved by prestigious multinational companies (Sanofi, AstraZeneca, Novartis).

8Is there a difference in quality between an imported medicine and one manufactured domestically under license from a foreign company?

No. At Dr. Abidi Pharmaceuticals, all licensed medications are produced with the exact same quality as their imported counterparts. This is because the raw materials, along with all manufacturing and quality control procedures, are meticulously transferred and implemented directly from the originator company. This quality alignment is continuously evaluated and verified through periodic quality audits conducted by inspectors from the partner foreign companies.

9What procedures are followed if there is a need to verify the quality of a specific production batch?

Should the need arise to verify the quality of a specific production batch (lot), our first step isand halt its distribution until its quality status is thoroughly confirmed. Subsequently, we investigate the specific quality factor that may have been compromised. Utilizing our fully equipped laboratories, we conduct targeted quality testing on randomized samples from the batch. If the medication is proven to be non-compliant, a full product recall for that specific batch is initiated, followed by safe destruction in accordance with legal protocols. Conversely, if high quality is verified, the distribution process resumes normally.

10What tests or research are conducted to demonstrate the high quality of a medication?

Following the production of a specific batch and prior to its release from the manufacturing warehouse, random samples are drawn for rigorous evaluation. In Dr. Abidi’s advanced Quality Control (QC) laboratories, these samples undergo dissolution testing in simulated gastric or intestinal environments, where the released concentration of the active ingredient and other substances is precisely measured. If a batch fails to pass these stringent quality tests, it is quarantined and subsequently destroyed following legal procedures. Only batches that successfully pass all analytical tests are granted release authorization for distribution to authorized healthcare centers. Furthermore, Dr. Abidi Pharmaceuticals actively welcomes and supports clinical research projects involving our manufactured medications. Numerous national universities have conducted clinical studies in collaboration with us, and many research projects are currently underway—all of which clinically demonstrate our utmost confidence in the quality of our products.