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 ... 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 ... 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 ... 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 ... 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 ... 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 ... Read More »
Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Azithromycin Oral Suspension 100 mg /5 mL and 200 mg/5 mL. Azithromycin oral suspension, a generic version of Pfizer Inc’s Zithromax oral suspension. The product will be launched in November 2018. Azithromycin ... Read More »
Zydus Cadila has received the final approval from the US Food and Drug Administration (USFDA) to market Exemestane Tablets, (US RLD – AROMASIN Tablets), 25 mg. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. The estimated sale for Exemestane Tablets is $68.6 million. Exemestane belongs ... Read More »
Vivimed Labs’ API manufacturing facility located in Cuernavaca, Mexico has been inspected by the US Food and Drug Administration (USFDA). The inspection was successful and company obtained Establishment Inspection Report (EIR). This was a routine inspection by the USFDA. Vivimed Labs is engaged in providing specialty chemicals and pharmaceuticals products. ... Read More »
Cadila Healthcare’s Biologics manufacturing facility (Zydus Biologics) located at Ahmedabad has received an Establishment Inspection Report (EIR) from US Food and Drug Administration (USFDA) signifying the successful closure of the audit from August 14 to August 24, 2018, with zero 483 observations. Cadila Healthcare is an India-based pharmaceutical company. The ... Read More »
