News about "ANDA"

Alembic Pharmaceuticals Receives USFDA Final Approval for Diltiazem Hydrochloride Tablets

Alembic Pharmaceuticals has received final approval from the USFDA for its Diltiazem Hydrochloride Tablets in multiple strengths, a generic version of Cardizem used for managing certain types of angina. The approval adds to the company’s growing US portfolio, bringing its total ANDA count to 230, including 210 final and 20 tentative approvals.

ANDA | 18/11/2025 | By Dineshwori

USFDA Approves Alembic Pharmaceuticals' Sumatriptan Single-Dose Autoinjector

Alembic Pharmaceuticals has received USFDA approval for its Abbreviated New Drug Application (ANDA) for Sumatriptan single-dose autoinjector, deemed therapeutically equivalent to GlaxoSmithKline’s Imitrex STATdose System in 4 mg/0.5 mL and 6 mg/0.5 mL strengths.

ANDA | 10/11/2025 | By Dineshwori

FDA Announces New ANDA Prioritisation Pilot to Support US Generic Drug Manufacturing and Testing

More than half of pharmaceuticals distributed in the US are manufactured overseas. Further, the US is reliant on overseas sources for Active Pharmaceutical Ingredients (APIs). As of 2025, only nine percent of API manufacturers are in the US, compared to 22 percent in China and 44 percent in India.

ANDA | 06/10/2025 | By Dineshwori |  104

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 |  799

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 |  574

Antheia Appoints Richard Sherwin as Head of Commercialization

Antheia Appoints Richard Sherwin as Head of Commercialization

ANDA | 18/08/2023 | By Sudeep Soparkar |  841

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 |  935

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 |  598

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 |  955

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 |  814