Last Updated on October 10, 2024 by The Health Master
New Delhi: Glenmark Pharmaceuticals Limited has recently announced that the US Food and Drug Administration (USFDA) has issued Form 483 with one observation after an inspection at the company’s formulation manufacturing facility based out of Aurangabad, India.
A USFDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that, in their judgment, may constitute violations of the Food, Drug, and Cosmetic (FD&C) Act and related Acts.
The inspection was held between June 27, 2022, and July 1, 2022.
“The company is committed to undertaking all necessary steps required to address their observation at the earliest.
The Company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe,” the company said in a BSE filing.
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
USFDA gives 10 observations to Sun Pharm
USFDA gives Zero Observations to SMS Lifesciences
USFDA issues 4 Observations to Lupin for Tarapur Facility
NPPA fixes retail prices of 84 drug formulations
9th edition of IP released containing 3,152 Monographs
USFDA gives final approval for Lacosamide Injection
USFDA clears watch-like wearable BP monitoring technology
PCI to introduce One Nation One Cadre guideline for pharmacy across the country
QR code could curb circulation of fake, spurious and substandard medicines
IPGA Telangana organizes National level Symposium on Medical Device Regulation in India
Public Service Commission yet to fill up vacant Drugs Inspector posts
These 4 countries accept Indian Pharmacopoeia (IP) as book of standard
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:
