USFDA inspects Shilpa Medicare’s bio-analytical laboratory in Hyderabad

This newly set up Centre for bio-analytical testing has already received European Regulatory Authority clearance recently

Shilpa Medicare Analytical Services Division gets VAI status from USFDA after GMP inspection

This is the second US FDA GMP inspection of this facility within one year

Shilpa Medicare gets 2 minor observations from USFDA for Unit VII, Analytical Services Division

The company will be submitting the responses to US FDA observations within stipulated timeline

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

PIB: Quality control of Ayush drugs

Biocon Biologics receives EU GMP Certification for its in Bengaluru

This integrated, multi-product facility houses manufacturing suites, analytical testing laboratories and warehousing.

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