Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 2

Results For "BSE"

1043 News Found

Granules’ packaging facility in US completes FDA inspection with zero observations
News | December 05, 2025

Granules’ packaging facility in US completes FDA inspection with zero observations

Granules Consumer Health serves as Granules’ front-end division for OTC products in the US


Lupin receives 7 observations from USFDA for Goa manufacturing facility
Drug Approval | November 24, 2025

Lupin receives 7 observations from USFDA for Goa manufacturing facility

Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe


Shilpa Medicare receives 8 observations from USFDA for Unit 4 at Jadcherla
Drug Approval | November 24, 2025

Shilpa Medicare receives 8 observations from USFDA for Unit 4 at Jadcherla

The Unit is approved by major regulators like EMA, Europe; Health Canada, Anvisa, Brazil and TGA, Australia


Aurobindo Pharma gets 9 observations from USFDA for Unit 2 of Eugia Pharma Specialities
News | November 15, 2025

Aurobindo Pharma gets 9 observations from USFDA for Unit 2 of Eugia Pharma Specialities

The observations are procedural in nature and will be responded to within the stipulated time


Lupin Bioresearch Center receives zero observations from USFDA
Drug Approval | November 08, 2025

Lupin Bioresearch Center receives zero observations from USFDA

A bio-analytical Remote Regulatory Assessment was also conducted from October 30 to November 7, 2025, and concluded with no observations


Biocon gets 1 USFDA observation for Cranbury site
Drug Approval | October 14, 2025

Biocon gets 1 USFDA observation for Cranbury site

The Cranbury facility represents a strategic advancement of the company's operations in the Unted States


FDA completes inspection of Indoco’s API manufacturing facility at Patalganga with zero observations
Drug Approval | September 19, 2025

FDA completes inspection of Indoco’s API manufacturing facility at Patalganga with zero observations

The inspection concluded with zero form 483 observations


Zydus Lifesciences gets 4 USFDA observations for Jarod Injectable facility
News | September 06, 2025

Zydus Lifesciences gets 4 USFDA observations for Jarod Injectable facility

Zydus will work closely with the USFDA to address and resolve the observations in an expeditious manner