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Results For "USFDA"

1202 News Found

Zydus’ SEZ II, Ahmedabad plant clears USFDA inspection with nil observations
Drug Approval | August 16, 2025

Zydus’ SEZ II, Ahmedabad plant clears USFDA inspection with nil observations

The inspection concluded with NIL observations


Indoco Remedies receives final USFDA approval for rivaroxaban tablets
Drug Approval | August 13, 2025

Indoco Remedies receives final USFDA approval for rivaroxaban tablets

Rivaroxaban is used to treat venous thromboembolism


Zydus receives final approval from USFDA for Diltiazem Hydrochloride Tablets USP
Drug Approval | August 11, 2025

Zydus receives final approval from USFDA for Diltiazem Hydrochloride Tablets USP

Diltiazem works by relaxing blood vessels, which reduces the workload on the heart and increases blood and oxygen supply to the heart muscle


Zydus receives final approval from USFDA for Prucalopride Tablets
Drug Approval | August 09, 2025

Zydus receives final approval from USFDA for Prucalopride Tablets

Prucalopride is prescribed for chronic idiopathic constipation


Alembic Pharmaceuticals announces USFDA final approval for Carbamazepine ER Tablets USP
Drug Approval | July 27, 2025

Alembic Pharmaceuticals announces USFDA final approval for Carbamazepine ER Tablets USP

Carbamazepine Extended-Release Tablets are indicated for use as an anticonvulsant drug


NATCO Pharma API unit in Mekaguda receives EIR from USFDA
Drug Approval | July 24, 2025

NATCO Pharma API unit in Mekaguda receives EIR from USFDA

The company received one observation in the Form-483


Lupin receives USFDA approvals for Liraglutide and Glucagon injectable products
Drug Approval | July 24, 2025

Lupin receives USFDA approvals for Liraglutide and Glucagon injectable products

Both these products will be manufactured at Lupin’s Injectable facility at Nagpur, India


Zydus receives tentative approval from USFDA for Ibrutinib tablets
Drug Approval | July 24, 2025

Zydus receives tentative approval from USFDA for Ibrutinib tablets

Ibrutinib tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad


Lupin receives Form 483 with 4 observations from USFDA for Pithampur unit-2
Drug Approval | July 18, 2025

Lupin receives Form 483 with 4 observations from USFDA for Pithampur unit-2

The company is addressing these observations comprehensively


Shilpa Medicare receives EIR from USFDA for Unit VI, Bengaluru
Drug Approval | July 17, 2025

Shilpa Medicare receives EIR from USFDA for Unit VI, Bengaluru

This facility is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms