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Results For "Alembic"

120 News Found

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


USFDA inspection at Alembic Pharmaceuticals’ facility at Jarod
Drug Approval | December 20, 2022

USFDA inspection at Alembic Pharmaceuticals’ facility at Jarod

None of the observations are related to data integrity and management believes that they are addressable


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 EIR for oncology injectable formulation facility at Panelav
Drug Approval | December 12, 2022

Alembic receives EIR for oncology injectable formulation facility at Panelav

This was a pre-approval inspection to cover our Oncology Injectable drug products for which ANDAs were filed with USFDA


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


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.


Alembic receives USFDA approval for Ketorolac Tromethamine Injection
Drug Approval | November 04, 2022

Alembic receives USFDA approval for Ketorolac Tromethamine Injection

Ketorolac Tromethamine is advised for the short-term management of moderately severe acute pain in adult patients