Nesher Pharma's Generic Doxycycline Hyclate Receives Approval in the US
Granules India Limited announced today that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Potassium Chloride Extended-Release Capsules USP, 8 mEq (600 mg) and 10 mEq (750 mg). It is bioequivalent to the reference listed drug product (RLD), Micro-K Extended-Release Capsules, 8 mEq and 10 mEq, of Nesher Pharmaceuticals (USA) LLC. The product would be manufactured at our Hyderabad facility and is expected to be launched shortly.
Nesher Pharms` Generic Acetaminophen;Butalbital;Caffeine Receives Approval In US
The cleaning procedures are so poor at a Zydus Cadila plant in India that the FDA says a sampling found 10 different tablet products that were cross-contaminated with API residue from another drug during production.
Nesher Pharms` Generic Amphetamine Aspartate;Amphetamine Sulfate;Dextroamphetamine Saccharate;Dextroamphetamine Sulfate Receives Approval In US
Indian Pharmaceutical companies and their subsidiaries have established strong presence in US during last couple of years with higher ANDA approvals. The loss of patent exclusivity and cost cutting measures adopted by several nations pushed the demand for generic segment. Indian pharma companies enhanced their investments in research and development (R&D) and successfully received higher approvals from US FDA during last decade. Out of total 5,350 ANDA approvals between 2009 to 2018, Indian companies have secured 34.4% of these approvals and received total 1,842 ANDA final approvals. Further, out of total 1,310 tentative approvals, Indian companies grab 500 tentative approvals from US FDA which worked out to over 38.2%.
Nesher Pharms' Generic Amphetamine Aspartate;Amphetamine Sulfate;Dextroamphetamine Saccharate;Dextroamphetamine Sulfate Receives Tentative Approval in US
Nesher Pharms's Generic Amphetamine Aspartate;Amphetamine Sulfate;Dextroamphetamine Saccharate;Dextroamphetamine Sulfate Receives Tentative Approval in US
Nesher Pharms`s Generic Busulfan Receives Approval In US
Nesher Pharm’s Generic Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Receives Approval In US