Biocon passes US-FDA inspection at Vishakapatanam plant

Biocon said the plant inspection conducted by the US Food and Drug Administration at its Vishakapatanam plant passed without incident.

“US FDA inspected our Active Pharmaceutical Ingredients (API) manufacturing facility in Wishakhapatnam, Andhra Pradesh from September 11 to 15, 2017 and completed the audit without any observations,” it said.

No form 483 was issued, it added.

Biocon is among the most prestigious pharma companies in India.

It manufactures generic active pharmaceutical ingredients (APIs) that are sold in the developed markets of the United States and Europe.

It also manufactures biosimilar insulins, which are sold in India as branded formulations and in both bulk and formulation forms.

It is one of the few Indian pharma companies that are present in the research space in a strong way.

Located with R&D in Bangalore and API unit in Hyderabad, India, Biocon has two subsidiaries— Syngene and Clinigene.

Biocon’s presence straddles four main therapeutic areas—Diabetology, Cardiology, Nephrology and Oncology.

Syngene International is engaged drug discovery while Clinigene International is in the clinical development space.