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1783 News Found

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


Vaishali Pharma signs partnership agreement with Jark Pharma
News | December 22, 2022

Vaishali Pharma signs partnership agreement with Jark Pharma

As per the agreement, NSE-listed Vaishali Pharma Limited will take over the entire domestic and international marketing of Jark Pharma’s portfolio of quality based ayurvedic products


Glenmark Pharmaceuticals receives ANDA approval for Nicardipine Hydrochloride Capsules
Drug Approval | December 20, 2022

Glenmark Pharmaceuticals receives ANDA approval for Nicardipine Hydrochloride Capsules

According to IQVIA sales data for the 12-month period ending October 2022, the Cardene Capsules, 20 mg and 30 mg market achieved annual sales of approximately US $10.9 million


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


Astellas, Seagen and Merck announce FDA acceptance of sBLA for PADCEV for urothelial cancer
Drug Approval | December 20, 2022

Astellas, Seagen and Merck announce FDA acceptance of sBLA for PADCEV for urothelial cancer

This combination has the potential to be the first treatment option combining an antibody-drug conjugate plus an immunotherapy in this treatment setting


Briefs: Jubilant Pharmova and Apollo Hospitals Enterprise
News | December 15, 2022

Briefs: Jubilant Pharmova and Apollo Hospitals Enterprise

The company will submit an action plan on the observations and will engage with US FDA for next steps.


Kerala Ayurveda receives US patent for its herbal formulation
News | December 15, 2022

Kerala Ayurveda receives US patent for its herbal formulation

The patent also covers the efficacy of the herbal composition in the management of metabolic syndrome disorders


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


Zydus receives USFDA approval to market Silodosin and Pregabalin capsules
Drug Approval | December 12, 2022

Zydus receives USFDA approval to market Silodosin and Pregabalin capsules

Silodosin capsules treat signs and symptoms of an enlarged prostate gland