Strides Pharma Science’s step‐down wholly owned subsidiary, Strides Pharma Global Pte, has received approval for Gabapentin Capsules USP, 100 mg, 300 mg, and 400 mg from the United States Food and Drug Administration (USFDA). Gabapentin Capsules is a generic version of Neurontin Capsules of Pfizer. The product received approval in the first cycle of review … Read more
US Food and Drug Administration (USFDA) has issued four minor observations to JB Chemicals & Pharmaceuticals’ solid oral manufacturing facility at Panoli, Gujarat. The company proposes to address these observations within next 15 days. These observations will not have any impact on the current business and will facilitate ANDA of capsule product that is already … Read more
Zydus Cadila has received tentative approval from the US Food and Drug Administration (USFDA) to market Colchicine Tablets USP (US RLD – ColcyrsTM), 0.6 mg. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. This medication is used to prevent or treat attacks of gout (also called gouty arthritis). This condition … Read more
Zydus Cadila has received the final approval from the US Food and Drug Administration (USFDA) to market Clobetasol Propionate Cream, (USRLD Temovate Cream), 0.05%. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. Clobetasol Propionate is a topical (for the skin) steroid used to treat inflammation and itching caused by a … Read more
Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Alogliptin Tablets, 6.25 mg, 12.5 mg and 25mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), NESINA Tablets, 6.25 mg, 12.5 mg and 25mg of Takeda Pharms USA. … Read more
Lupin has received tentative approval for its Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg from the United States Food and Drug Administration (USFDA) to market a generic version of Sunovion Pharmaceuticals Inc.’s (Sunovion) Latuda Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg. Lupin’s Lurasidone … Read more
Glenmark Pharmaceuticals’ subsidiary — Glenmark Pharmaceuticals Inc, USA has been granted final approval by the United States Food and Drug Administration (USFDA) for Hydrocortisone Valerate Cream USP, 0.2%, a generic version of Westcort Cream, 0.2%, of Sun Pharmaceutical Industries Inc. According to IQVIA sales data for the 12-month period ending August 2018, the Westcort Cream, … Read more
