High manufacturing, quality, and safety standards are instrumental to Petrovax Pharm’s successful operation. For 20 years, the company has been developing and manufacturing efficacious, and safe innovative pharmaceuticals and vaccines for the benefit of human health and improvement of living standards.

The company’s manufacturing complex in Moscow region is one of the most advanced and high-tech biopharmaceutical facilities in Russia. The facility was built and operates in full compliance with the Russian and international Good Manufacturing Practice (GMP) and ISO 9001 standards.

From the outset, the facility aimed at the use of the cutting-edge vaccine and immunobiologicals manufacturing technologies with observance of all applicable environmental safety regulations. Presently, the facility operates in accordance with measures aimed at providing for safe conditions in terms of human activities and health.

The facility manufactures finished dosage forms in ampoules, vials, prefilled syringes, and plastic containers. The facility capacity provides for manufacturing more than 160 million doses of immunobiological products a year.

Petrovax Pharm is one of the first Russian facilities issued European, Iranian, and Russian GMP certificates.

Ideal aseptic conditions, clear area zoning, and automated product manufacturing are fundamentals of the pharmaceutical facility operations. Actions of each employee can be tracked and assessed in real time. Qualification of all utility systems, and the entire list of validation activities — from clean rooms to manufacturing and packaging processes — are performed on an annual basis. The raw and other materials are accepted from approved vendors only.

All Petrovax Pharm’s products go through a full lifecycle from molecule development to finished dosage form. Preclinical and clinical product studies are conducted in strict compliance with the applicable legislation, Russian, and international requirements. Quality control of pharmaceuticals and vaccines produced is provided for at all stages from raw material sampling to finished product control. Petrovax Pharm’s in-house Quality Unit currently has more than 90 employees.

For many years, the company has had a quality management system (QMC) in place confirmed by an ISO:9001 certificate.

High manufacturing standards provide for the implementation of international projects, and full-cycle manufacturing technology transfer to Russia. Therefore, such world leaders as Pfizer, Abbott, Boehringer Ingelheim etc. cooperate and launch joint projects with Petrovax Pharm.

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