Lupin Gains Approval from FDA for Valbenazine Capsules
Lupin Ltd. has received approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Valbenazine Capsules.
ANDA | 09/04/2024 | By Aishwarya | 239
Marksans receives USFDA approval for Guaifenesin Extended-Release Tablets (OTC)
Marksans receives USFDA approval for Guaifenesin Extended-Release Tablets (OTC)
ANDA | 23/08/2023 | By Sudeep Soparkar | 312
Antheia Appoints Richard Sherwin as Head of Commercialization
Antheia Appoints Richard Sherwin as Head of Commercialization
ANDA | 18/08/2023 | By Sudeep Soparkar | 326
NATCO receives final approval for Tipiracil Hydrochloride and Trifluridine for the US market
NATCO receives final approval for Tipiracil Hydrochloride and Trifluridine for the US market
ANDA | 19/06/2023 | By Sudeep Soparkar | 547
Granules India Ltd received ANDA Approval for Metoprolol Succinate ER Tablets
Granules India Limited today, announced that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Metoprolol Succinate Extended-Release Tablets USP, 25 mg, 50 mg, 100 mg and 200 mg.
ANDA | 14/06/2023 | By Sudeep Soparkar | 234
Nexus Pharmaceuticals receives FDA inspection of pharma manufacturing facility in Wisconsin
The Pleasant Prairie facility, which spans more than 84,000 square feet, is equipped with state-of-the-art isolator technology and adheres to the highest current good manufacturing practice (CGMP) standards
ANDA | 08/05/2023 | By Sudeep Soparkar | 486
Indoco receives EIR for its manufacturing facility in Goa
Indoco expects the change in compliance status to pave the way for approvals of ANDAs submitted from this site
ANDA | 04/05/2023 | By Sudeep Soparkar | 454
Granules India receives ANDA Approval for Losartan Potassium tabs
Granules now have a total of 54 ANDA approvals from the US FDA
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ANDA | 27/02/2023 | By Sudeep Soparkar | 471
Alembic Pharma's oncology injectable formulation facility at Panelav bags EIR from US FDA
The company had also started receiving ANDA approval for manufacturing at this facility
ANDA | 13/12/2022 | By Sudeep Soparkar | 566
Zydus Lifesciences bags US FDA approval to treat myxedema coma
The drug will be manufactured at the group's injectable manufacturing facility in Jarod, near Vadodara<br />
ANDA | 28/11/2022 | By Sudeep Soparkar | 336
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