Granules India gets USFDA’s nod for Loratadine Tablets

24 Dec 2019 Evaluate

The US Food & Drug Administration (USFDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules India, for Loratadine Tablets USP, 10 mg (OTC). The approved ANDA is the bioequivalent to the Reference Listed Drug (RLD), Claritin Tablets 10 mg by Bayer HealthCare LLC. The company intends to commercialise this product shortly.

Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).

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