Alembic Pharmaceuticals, one of India’s biggest drug makers, received two observations from US FDA officials who inspected its plant at Karkhadi in Gujarat.
Observations, given in Form 483, indicate that the inspectors were not fully satisfied with what they found during the visit.
In a Form 483, the FDA typically outlines conditions or practices at a drug-making unit that may cause the products made there to be in violation of the US agency’s standard production requirements.
The discrepancies that they note are given in writing to the company for rectification.
The inspection at the plant, which makes active pharmaceutical ingredients or the core chemicals used to make medicines — was conducted from January 13 to January 17.
The company did not elaborate on the nature of the observations, whether they were data-integrity related, procedural and so on. It, however, said the checks were part of a ‘scheduled pre-approval inspection’.
A pre-approval inspection is conducted by the FDA before it issues a license to sell a product in the United States to ensure that the manufacturing processes and facilities used to output the product are in compliance with the standards laid down by the FDA.
Headquartered in Vadodara, Gujarat, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.
It is one of the leaders in branded generics in India and has a team of over 5000 marketing professionals in the country.
Alembic has six Formulation and three Active Pharmaceutical Ingredient (API) manufacturing facilities. Of the six Formulation facilities, five facilities are located near Vadodara in Gujarat – three at Panelav and two at Karakhadi and one in Sikkim.
Alembic currently manufactures general oral solids in Panelav, Gujarat and is in the process of putting up Oncology oral solids and Oncology injectable facilities at the same location.