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Results For "FDA-inspection"

111 News Found

Shilpa Medicare Hyderabad facility receives US FDA clearance
News | September 23, 2022

Shilpa Medicare Hyderabad facility receives US FDA clearance

The facility is identified as a testing laboratory in numerous ANDAs filed by Shilpa Medicare Limited and its agreed parties


Cipla receives EIR for Indore plant, Aurbindo for Raleigh
News | September 23, 2022

Cipla receives EIR for Indore plant, Aurbindo for Raleigh

The plant at Raleigh, North Carolina, USA owned by Aurolife Pharma has received an establishment inspection report (EIR)


Glenmark receives OAI from USFDA for Goa facility
News | August 28, 2022

Glenmark receives OAI from USFDA for Goa facility

Glenmark continues to cooperate with the US FDA and is committed to undertake all necessary steps required to address their observations at the earliest.


Cipla receives 6 observations from USFDA for Goa facility
Drug Approval | August 28, 2022

Cipla receives 6 observations from USFDA for Goa facility

There are no data integrity (DI) observations.


Glenmark  receives OAI communication from US FDA
Drug Approval | August 24, 2022

Glenmark receives OAI communication from US FDA

The company continues to cooperate with the US FDA and is committed to undertake all necessary steps required to address their observations at the earliest


Briefs: Marksans Pharma and Alkem
News | June 22, 2022

Briefs: Marksans Pharma and Alkem

The US FDA had conducted an inspection of Alkem Laboratories Limited's manufacturing facility located at St. Louis, USA.


USFDA concludes inspection of Shilpa Medicare with four observations
News | May 02, 2022

USFDA concludes inspection of Shilpa Medicare with four observations

The inspection was triggered by Shilpa's submission of applications for four ANDA's to seek approval to use this site as an alternate testing laboratory


Suven Pharmaceuticals acquires Casper Pharma for Rs 155 crore
News | April 05, 2022

Suven Pharmaceuticals acquires Casper Pharma for Rs 155 crore

Casper Pharma is a Hyderabad based SEZ company engaged in the formulations business. Post-purchase of shares, the target entity would become a wholly-owned subsidiary of SPL


Limited impact of short-term disruptions, growth momentum to continue in FY 23
News | March 03, 2022

Limited impact of short-term disruptions, growth momentum to continue in FY 23

Large players are adequately capitalised to make bigger investments to adjust for the ongoing fundamental shift in market opportunities


Promising prospects for Indian pharma: CLSA
News | September 17, 2021

Promising prospects for Indian pharma: CLSA

CLSA, a capital market and investment group organised an Investors’ Forum where five Indian pharma companies participated. Excerpts from the report