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Granules India’s arm gets USFDA’s nod for Colchicine Tablets

06 Feb 2020 Evaluate

Granules India’s wholly owned foreign subsidiary -- Granules Pharmaceuticals, Inc., has received approval from US Food & Drug Administration (USFDA) for the Abbreviated New Drug Application (ANDA) for Colchicine Tablets USP, 0.6 mg. It is bioequivalent to the reference listed drug product (RLD), Colcrys Tablets, 0.6 mg, of Takeda Pharmaceuticals USA, Inc. Colchicine Tablets are used for treatment of Familial Mediterranean Fever (FMF).

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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Company Name CMP
Sun Pharma. Inds. 1766.45
Dr. Reddys Labs. 1193.70
Cipla 1310.10
Lupin 1954.15
Zydus Lifesciences 1117.80
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