Alembic Pharmaceuticals said one of its dermatology-focused joint ventures, Aleor Dermaceuticals Ltd, received an Inspection Report for its formulation facility at Karakhadi, Gujarat from the United States Food and Drug Administration.
The USFDA had conducted an inspection at the facility from February 4-8.
Alembic holds 60% of Aleor, with Orbicular Pharmaceutical Technologies holding the rest.
The facility had received two observations from the food and drug regulator during the inspection.
The receipt of an Establishment Inspection Report (EIR) is usually considered good news. It means that the company can now use the facility to manufacture items that are meant to be sold in the US.
The Joint Venture between Alembic and Orbicular Pharmaceutical Technologies was formed in April 2016 to develop, manufacture and commercialise dermatology products for worldwide markets.
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.
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.