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973 News Found

Natco Pharma receives 8 observations from USFDA for Pharma Division at Kothur
Drug Approval | October 23, 2023

Natco Pharma receives 8 observations from USFDA for Pharma Division at Kothur

The company is confident of addressing all the observations within the stipulated time


Dr Reddy's Bachupally biologics facility gets USFDA Form 483 with 9 observations
Drug Approval | October 14, 2023

Dr Reddy's Bachupally biologics facility gets USFDA Form 483 with 9 observations

The USFDA inspectors issued the observations after a product pre-approval inspection of the biologics facility in Bachupally


Gland Pharma receives 2 observations under 483 for Pashamylaram facility
News | August 28, 2023

Gland Pharma receives 2 observations under 483 for Pashamylaram facility

The company is committed to address the observations and will submit its response to US FDA within the stipulated time


Lupin's Mandideep Unit-2 facility completes USFDA inspection with no observations
Drug Approval | August 16, 2023

Lupin's Mandideep Unit-2 facility completes USFDA inspection with no observations

The inspection was conducted from August 7 to August 11, 2023 and concluded without any observations.


Granules Pharmaceuticals successfully completes USFDA post marketing adverse drug experience inspection with zero observations
Drug Approval | August 05, 2023

Granules Pharmaceuticals successfully completes USFDA post marketing adverse drug experience inspection with zero observations

The inspection was conducted at Granules Pharmaceuticals Inc. (GPI) from July 31, 2023 to August 03, 2023


Aurobindo Pharma gets 3 observations from USFDA for Unit 3 at Bachupally Village
Drug Approval | July 24, 2023

Aurobindo Pharma gets 3 observations from USFDA for Unit 3 at Bachupally Village

Aurobindo will respond to the US FDA within the stipulated timelines


Ipca Laboratories receives 8 observations from USFDA
Drug Approval | June 24, 2023

Ipca Laboratories receives 8 observations from USFDA

The company will submit its comprehensive response on these observations to the USFDA


Hikal announces USFDA audit with zero observations
Drug Approval | May 16, 2023

Hikal announces USFDA audit with zero observations

This latest audit re-emphasizes Hikal's commitment towards maintaining the best in class quality, compliance and regulatory standards across our manufacturing sites


Ipca Laboratories gets 3 observations for Piparia, Silvassa unit
Drug Approval | April 27, 2023

Ipca Laboratories gets 3 observations for Piparia, Silvassa unit

The company will submit its comprehensive response on these observations to the US FDA within the stipulated time