Last Updated on December 31, 2023 by The Health Master
Hyderabad: Suven Pharmaceuticals Ltd has announced that the US Food and Drug Administration (USFDA) has completed a pre-approval inspection at the Casper Pharma Private Limited formulations manufacturing facility situated at GMR Hyderabad SEZ, a wholly owned subsidiary of Suven Pharmaceuticals Limited in Hyderabad, India.
The inspection was conducted from July 25th through July 29th, 2022.
The audit is part of the agency’s inspection of three product applications filed and slated to be manufactured at this site.
According to Venkat Jasti, Managing Director of Suven Pharmaceuticals Limited, “We are happy to have completed the audit successfully with Zero observations and at the end of the inspection, no form 483 was issued by USFDA which signifies compliance and conformance to applicable cGMP regulations.”
When an investigator(s) has(have) observed any conditions that, in their opinion, may constitute violations of the Food, Drug, and Cosmetic (FD&C) Act and related Acts, a USFDA Form 483 is issued to firm management at the conclusion of an inspection.
Seven Pharmaceuticals Limited, a company incorporated in November 2018, has become a Wholly Owned Subsidiary of Suven Life Sciences Limited, effective February 2019.
USFDA issues Form 483 for six observations to Granules Pharma
USFDA issues Form 483 for 3 observations to Biocon for Telangana plant
USFDA issues 2 observations to Cipla Indore Plant
USFDA issues 6 observations to Glenmark Baddi Facility
USFDA issues 8 Observations to Panacea Biotec for Baddi Facility
USFDA gives 5 observations to Glenmark Pharma for Goa facility
AYUSH doctors can practise allopathy with own system: High Court
7,700 drug samples declared not of standard quality
USFDA gives nod for Diclofenac Sodium Topical Gel
USFDA gives nod for generic birth control pills
New technology that deactivates COVID-19 virus in just 1 minute
Foreign MBBS holders: Registration only after 2 Years internship: NMC
USFDA gives nod for Belimumab to treat Paediatric Patients
CDSCO issues alert on Blood Purification Device hemoperfusion cartridge
CDSCO gives nod to make generic version of Pfizer’s Covid-19 pill
Latest Notifications regarding Pharmaceuticals
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
