Aurobindo gets API facility approval

By Staff Reporter

- Last updated on GMT

Related tags: Good manufacturing practice, Pharmacology, Us

Indian company Aurobindo Pharma has received UK approval on its
active pharmaceutical ingredient (API) facility in Kazipally.

The Medical Health Regulatory Authority (MHRA) granted a certificate of Good Manufacturing Practice (GMP) for the company's unit-VIII facility, which is situated on the outskirts of Hyderabad. The facility consists of four production blocks, three of which manufacture APIs for anti-retro virals, central nervous system, anti-allergics and cardiovascular system drugs. The facility manufactures zidovudine, the first approved treatment for HIV/AIDS marketed under the brand names Retrovir and Retrovis, and efavirenz, another treatment for HIV sold under the brand names Sustiva and Stocrin. The cGMP certificate will also be recognised by other regulatory agencies around the world. The company is one of the largest producers of APIs in Asia and has more than 100 currently being commercially used. The company also manufacturers generics. Aurobindo's portfolio covers six major therapeutic areas, including antibiotics and gastroenterologics and markets the products in more than 100 countries. The facility has already received successful inspections from the US food and Drug Administration (FDA) and the World Health Organisation (WHO). A facility with cGMP production certification is recognized as having proper equipment, technical expertise, controls and procedures to produce API for human applications. Last year, Aurobindo took over a part of Senor Organics, a small pharmaceutical manufacturer making APIs and intermediates, in a decision to shift the company's focus back to Indian production after looking at China. Senor specialised in piperazine and indole derivatives used in a variety of drugs.

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