Granules India gets USFDA nod for allergy treatment drug Loratadine

"The US Food & Drug Administration (USFDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules India Ltd, for Loratadine tablets USP, 10 mg (OTC)," Granules India said in a filing to BSE.

New Delhi: Granules India on Tuesday said the US health regulator has given its approval to the abbreviated new drug application filed by the drug firm for Loratadine tablets used to treat allergies.

"The US Food & Drug Administration (USFDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules India Ltd, for Loratadine tablets USP, 10 mg (OTC)," Granules India said in a filing to BSE.

The approved ANDA is bioequivalent to the Reference Listed Drug (RLD), Claritin tablets 10 mg by Bayer HealthCare LLC, the filing said.

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The company further said that it intends to commercialise this product "shortly".

Granules India was formed in 1984 as Triton Laboratories. Triton produced Paracetamol API at its Bonthapally factory on the outskirts of Hyderabad. The company manufactures several off-patent drugs, including Paracetamol, Ibuprofen, Metformin and Guaifenesin, on a large scale for customers in the regulated and semi-regulated markets.

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