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Results For "ANDA-approvals"

145 News Found

Granules Pharmaceuticals receives ANDA approval for amphetamine mixed salts ER capsules
Drug Approval | January 25, 2023

Granules Pharmaceuticals receives ANDA approval for amphetamine mixed salts ER capsules

Granules now have a total of 53 ANDA approvals from USFDA


USFDA inspections gather pace; Indian pharma companies equipped to handle disruptions
Drug Approval | January 17, 2023

USFDA inspections gather pace; Indian pharma companies equipped to handle disruptions

The top 15 Indian pharma players have continued to experience anaemic growth in the US market over the five years ended FY22


Alembic receives USFDA final approval for Fesoterodine Fumarate Extended-Release Tablets
Drug Approval | January 07, 2023

Alembic receives USFDA final approval for Fesoterodine Fumarate Extended-Release Tablets

Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg, have an estimated market size of US$ 177 million for twelve months ending Sep 2022


Alembic receives USFDA final approval for Fulvestrant Injection
Drug Approval | December 27, 2022

Alembic receives USFDA final approval for Fulvestrant Injection

Fulvestrant Injection, 250 mg/5 mL, has an estimated market size of US $71 million for twelve months ending Sep 2022 according to IQVIA


Alembic Pharmaceuticals receives PAS approval from USFDA for Pregabalin capsules
Drug Approval | December 23, 2022

Alembic Pharmaceuticals receives PAS approval from USFDA for Pregabalin capsules

Pregabalin Capsules have an estimated market size of US $244 million for twelve months ending Sep 2022 according to IQVIA


Alembic receives USFDA final Approval for Desonide Cream
Drug Approval | December 12, 2022

Alembic receives USFDA final Approval for Desonide Cream

Desonide Cream, 0.05%, has an estimated market size of US $12 million for twelve months ending Sep 2022 according to IQVIA


Alembic receives USFDA final approval for Diclofenac Sodium Topical Solution USP
Drug Approval | December 02, 2022

Alembic receives USFDA final approval for Diclofenac Sodium Topical Solution USP

Diclofenac Sodium Topical Solution USP, 2% w/w has an estimated market size of US $512 million for twelve months ending Sep 2022 according to IQVIA


JB Pharma gets USFDA approval for its generic Venlafaxine Extended-Release Tablets
Drug Approval | December 01, 2022

JB Pharma gets USFDA approval for its generic Venlafaxine Extended-Release Tablets

This product is based on Osmotic Controlled Release Oral Delivery System technology


Alembic receives USFDA final approval for Nifedipine Extended-Release Tablets
Drug Approval | November 22, 2022

Alembic receives USFDA final approval for Nifedipine Extended-Release Tablets

Nifedipine Extended-Release Tablets have an estimated market size of US $56 million for twelve months ending September 2022


Alembic receives USFDA final approval for Cyclophosphamide Capsules
Drug Approval | November 14, 2022

Alembic receives USFDA final approval for Cyclophosphamide Capsules

Cyclophosphamide Capsules, 25 mg and 50 mg, have an estimated market size of US$ 8 million for twelve months ending Sep 2022 according to IQVIA.