Granules India gets nod for paracetamol tablets in USA

Pharmaceutical manufacturer Granules India Ltd said that it has received approval from the United States Food and Drug Administration to sell a bioequivalent version of Johnson & Johnson’s Tylenol tablets.

Acetaminophen Extended Release tablets, also known as Paracetamol, are used primarily for temporary pain management, including arthritis relief.

It will be sold in doses of 650 mg.

“With a capacity of over 24,000 metric tonnes per year of Acetaminophen and finished dosage capacity of more than 18 billion units/year, we are confident that we will ensure supply security to our customers which will support us to capture our target market share”, said Krishna Prasad Chigurupati, Chairman & Managing Director, Granules India.

Headquartered in Hyderabad, Granules India Ltd manufactures tablets, Pharmaceutical Formulation Intermediates (PFIs) and Active Pharmaceutical Ingredients (APIs) which are distributed in over 74 countries.

Granules manufactures several off-patent drugs, including Paracetamol, Ibuprofen, Metformin and Guaifenesin, on a large scale for customers in the regulated and semi-regulated markets.

Established in 1984, Granules has its offices in 60 countries. It has offices in India, the US and the United Kingdom and eight manufacturing facilities, including 6 in India and one each in the United States and China.