Alembic Pharma’s Panelav unit receives Establishment Inspection Report from USFDA

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Vadodara-headquartered Alembic Pharmaceuticals Ltd has informed BSE that the company’s formulation facility has received (EIR) from US & Drug Administration (USFDA) for the inspection carried out by them in March, 2016.

 

US accounts for nearly 80-85 per cent of Alembic’s international formulations business. The company’s unit had received minor observations from the (as a Form 483) from the US drug regulator in March this year.

 

A Form 483 is issued to a company after an inspection is completed and investigators have observed any condition which (in their judgement) may constitute violations of the Food, (FD&C) Act and related acts.

 

makes formulations for the regulated markets and has a capacity to manufacture seven billion tablets and capsules per year. The formulations business accounts for nearly 86 per cent of its revenues.

 

The share of international business is around 50 per cent in its turnover. The company has manufacturing facilities at Vadodara and in and in Baddi in Himachal Pradesh.

 

The facility already has certifications from international regulatory authorities like MHRA (UK), MCC (South Africa), according to company’s website.