Last Updated on July 13, 2024 by The Health Master
USFDA
Cipla Ltd. a leading global pharmaceutical company, has received a positive outcome following a recent inspection by the United States Food and Drug Administration (USFDA) at its manufacturing facility located in Kurkumbh, Maharashtra, India.
Voluntary Action Indicated (VAI)
In a filing with the Bombay Stock Exchange (BSE), Cipla announced that the USFDA classified the inspection as a Voluntary Action Indicated (VAI).
This designation signifies that while the USFDA may have identified certain areas for improvement, the agency deems them non-critical and does not plan to recommend any regulatory or administrative action against the company.
Addressing Observations for Continued Compliance
Earlier reports indicated that Cipla received one Form 483, a document issued by the USFDA to communicate potential observations during an inspection.
The company has assured investors and stakeholders that it is actively working to address the observation and will submit a comprehensive response to the USFDA within the stipulated timeframe.
About Cipla
Founded in 1935, Cipla is a well-established pharmaceutical company with a strong focus on:
- Agile and Sustainable Growth: The company prioritizes responsible business practices while achieving consistent growth.
- Complex Generics Expertise: Cipla holds a leading position in developing and manufacturing complex generic drugs.
- Strategic Market Focus: The company has a deep presence in key markets like India, South Africa, North America, and other regulated and emerging regions.
- Robust Product Portfolio: Cipla offers a diverse range of products across therapeutic segments like respiratory, antivirals, urology, cardiology, and more.
- Manufacturing Excellence: With 47 manufacturing sites globally, Cipla utilizes cutting-edge technology to produce over 50 dosage forms and 1500+ products, catering to over 80 markets worldwide.
This positive outcome from the USFDA inspection reinforces Cipla’s commitment to maintaining the highest standards of quality and compliance in its manufacturing practices.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
USFDA inspection concluded with positive report at Alkem
USFDA issues positive EIR to Lupin Limited
USFDA issues Form 483 with 4 observations to Biocon
USFDA issues Form 483 with 6 observations to Cipla for Goa facility
Stricter Regulations on Schedule G Drug Ads in India
Gist of the draft notification: Compounding of Offences under the Drugs and Cosmetics Act
Govt Considers Price Control on Nutraceuticals in India
Maharashtra FDA conducts raids at three different locations in Vasai
Telangana DCA seizes illegally stocked and overpriced medicines
USFDA approval granted for this chronic heart failure treatment drug
PCI frames new Regulations in accordance with Jan Vishwas Act
USFDA declines to approve this weekly Insulin
Excipients: Need to enforce stringent Regulatory Standards for quality
Indian Regulators Cracks Down with Mandatory Barcodes on Top Brands
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:
