Vadodara-headquartered Alembic Pharmaceuticals Ltd has informed BSE that the company’s formulation facility Panelav has received Establishment Inspection Report (EIR) from US Food & 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 Panelav 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, Drug and Cosmetic (FD&C) Act and related acts.
Panelav 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 Panelav in Gujarat and in Baddi in Himachal Pradesh.
The Panelav facility already has certifications from international regulatory authorities like MHRA (UK), MCC (South Africa), according to company’s website.