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512 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


Zydus receives tentative approval from USFDA for Levomilnacipran Extended-Release Capsules
Drug Approval | January 16, 2023

Zydus receives tentative approval from USFDA for Levomilnacipran Extended-Release Capsules

The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India


China, South Korea, and India driving innovation in medical robotics in APAC, says GlobalData
News | January 16, 2023

China, South Korea, and India driving innovation in medical robotics in APAC, says GlobalData

APAC to see a reduction in imported surgical robotics


Zydus receives final approval and 180 days shared exclusivity from USFDA for Brexpiprazole tablets
Drug Approval | January 13, 2023

Zydus receives final approval and 180 days shared exclusivity from USFDA for Brexpiprazole tablets

Brexpiprazole is an atypical antipsychotic indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults


Zydus receives final approval from the USFDA for Febuxostat Tablets
Drug Approval | January 10, 2023

Zydus receives final approval from the USFDA for Febuxostat Tablets

Febuxostat tablets had annual sales of USD 32 million in the United States according to IQVIA data (IQVIA MAT Sept. 2022).


Zydus receives final approval from USFDA for Triazolam Tablets
Drug Approval | December 31, 2022

Zydus receives final approval from USFDA for Triazolam Tablets

Triazolam tablets are used on a short-term basis to treat insomnia (difficulty falling asleep or staying asleep)


Stelis Biopharma’s CDMO partner receives approval for key ANDA from the USFDA
Drug Approval | December 29, 2022

Stelis Biopharma’s CDMO partner receives approval for key ANDA from the USFDA

The current approval is first of the many fillings made by the company's CDMO partners from the flagship facility in Bangalore


Zydus receives final approval and 180 days shared exclusivity from USFDA for Selexipag Tablets
Drug Approval | December 23, 2022

Zydus receives final approval and 180 days shared exclusivity from USFDA for Selexipag Tablets

Selexipag tablet is indicated in adults for the treatment of pulmonary arterial hypertension to delay disease progression and reduce the risk of hospitalization for PAH


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