NEWS
- Pharma & Biotech News #PharmaBuzz
- Weekly News Recap #Phispers
- Recent Product Approvals #GreenLight
- Quality Compliance Alerts #Warning!
- All News #Library
DRUGS & DEVELOPMENTS
MARKET INTEL by PharmaCompass
Create content with us, ask us
By PharmaCompass
2019-04-04
Impressions: 67 Article
In compliance, there was good news from Indoco Remedies which received clearance from the FDA for its sterile manufacturing facility (plant II) located in Goa, India. The site had received a warning letter in March 2017.
The facility manufactures finished dose pharmaceuticals and had been inspected by the FDA between November 14 and 21, 2018. The November inspection led to Indoco receiving two observations, which Indoco Remedies said at the time were “minor” in nature and none of them were a repeat observation.
Several pending abbreviated new drug applications (ANDAs) from this facility will now be approved, the company said.
Jubilant’s Nanjangud facility classified as OAI: After a warning letter issued few weeks back to its Roorkee (India) finished dosage form manufacturing facility, there is more bad news for Jubilant Life Sciences. The company’s API facility located at Nanjangud, Mysore, was classified by the USFDA as ‘Official Action Indicated’. An OAI implies that regulatory and/or administrative actions will be recommended, and that the FDA may withhold approval of any pending applications or supplements in which this facility is listed.
The company’s API facility in Nanjangud was inspected between December 10 and 18, 2018 and had received a Form 483 with 12 observations.
The inspection of the Nanjangud site, which produces many APIs including valsartan, raised concerns over the failure to identify the root cause of genotoxic and other impurities in their APIs. FDA inspectors found the analytical methods and cleaning procedures followed at the site to be deficient. FDA also raised cross contamination concerns after it uncovered dirty non-dedicated equipment and found that the building and facilities were not adequately maintained.
No data integrity observations found at Cipla’s units: Indian drug major Cipla announced it had received eight good manufacturing practices observations from the US health regulator after inspection of three units at its Kurkumbh plant in Maharashtra from March 11, 2019 to March 20, 2019.
In their recently posted BSE filing, Cipla said: “There are no data integrity (DI) observations.”
The stock exchange filing also reports that the company received 10 observations pertaining to the pre-approval inspection (PAI) for a novel technology product slated for approval beyond 2024. Cipla stated that these observations are product specific, while GMP observations relate to the manufacturing and quality processes.
The PharmaCompass Newsletter – Sign Up, Stay Ahead
Feedback, help us to improve. Click here
Image Credit : #Phisper Infographic by SCORR MARKETING & PharmaCompass is licensed under CC BY 2.0
“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”
