News about "ANDA"

Lupin Gains Approval from FDA for Valbenazine Capsules

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)

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

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

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 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

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 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 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

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

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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