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Tag Archives: USFDA

Glenmark receives tentative ANDA approval for generic Vesicare Tablets

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (USFDA) for Solifenacin Succinate Tablets, 5 mg and 10 mg, the generic version of Vesicare Tablets, 5 mg and 10 mg of Astellas Pharma US Inc. According to IMS Health sales data ... Read More »

Zydus Cadila receives USFDA approval for Levofloxacin Injection

Zydus Cadila has received the final approval from the USFDA to market Levofloxacin Injection, 500 mg/20 mL and 750 mg/30 mL (25 mg/mL). Levofloxacin is used in the treatment of bacterial infections and will be produced at the group’s formulations manufacturing facility at Moraiya, Ahmedabad. This is significant as it ... Read More »

Claris Lifesciences undergoes USFDA audit for Pharmacovigilance

Claris Lifesciences (CLL) along with its wholly owned subsidiary Claris Injectables (CIL) has underwent a successful USFDA Pharmacovigilance (PV) audit from May 29 to May 31 with No Observation (i483s). Claris Lifesciences is engaged in manufacturing of drugs and pharmaceutical products. The Company manufactures and markets products across multiple delivery ... Read More »

Strides Shasun gets USFDA’s nod for Ibuprofen Tablets

Strides Shasun has received approval from the United States Food & Drug Administration (USFDA) for Ibuprofen Tablets USP, 200 mg (OTC). The US market for Ibuprofen Tablets USP 200 mg (OTC) is around $520 Million. The approval further strengthens company’s fast growing global OTC franchise. The product will be marketed ... Read More »

Glenmark receives final approval for generic version of Strattera Capsules

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Atomoxetine Capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg, the generic version of Strattera Capsules, 10 mg, 18 mg, 25 mg, ... Read More »

Strides Shasun completes USFDA inspection at Bangalore facility with 3 observations

Strides Shasun has completed the United States Food & Drug Administration (USFDA) inspection at its Bangalore facility. The company has been issued a Form 483 with 3 observations. None of these observations relate to data integrity and quality control. The company will address these observations comprehensively. Strides Shasun (formerly known ... Read More »

Glenmark receives final approval for generic version of Bystolic Tablets

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Nebivolol Tablets, 2.5 mg, 5 mg, 10 mg and 20 mg, the generic version of Bystolic Tablets, 2.5 mg, 5 mg, 10 mg and 20 mg, of Forest Laboratories, LLC ... Read More »

Zydus Cadila receives final approval for Acamprosate Calcium Tablets

Zydus Cadila has received the final approval from the USFDA to market Acamprosate Calcium Delayed-Release Tablets, 333 mg. This medication is used for maintenance of abstinence from alcohol in patients with alcohol dependence. The drug will be produced at the group’s formulations manufacturing facility at Baddi. The group now has ... Read More »

Lupin gets six observations from USFDA for Indore plant: Report

Lupin has reportedly received 6 USFDA Form 483 observations for its Indore plant. The facility was inspected by the US drug regulator between May 8 and May 19, 2017. Earlier, USFDA has issued eight observations for the company’s Aurangabad unit, which was inspected between April 17 and 26, 2017. Lupin ... Read More »

USFDA accepts Sun Pharma’s application for Tildrakizumab

The US Food and Drug Administration (USFDA) has accepted Sun Pharmaceutical Industries’ Biologics License Application (BLA) for tildrakizumab. The USFDA filing acceptance follows the acceptance of the regulatory filing of tildrakizumab by the European Medicines Agency (EMA) in March 2017. Tildrakizumab is an investigational IL-23p19 inhibitor being evaluated for the ... Read More »