India 2019 – R&D Highs, Compliance Woes And Other Lows
2019 saw Indian companies advance innovation efforts and build and expand their specialty portfolios and biosimilars businesses. But manufacturing compliance issues weighed down several firms while on another front charges against the Singh brothers of Ranbaxy escalated.
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FDA’s Record-Number GMP Warnings In FY 2019 Included First Of A Kind
Total GMP warnings in FY19 was 98, more than half to US firms. Warning to Dollar Tree “should serve as a reminder that although distributors may not be subject to CGMP requirement themselves, they are responsible for ensuring the drugs they distribute into interstate commerce are not adulterated,” says CDER compliance chief Donald Ashley.
Lupin’s Karkaria On Biosimilars Pushback And Interchangeability
Lupin's biotech president notes push-back by innovator firms against biosimilars in the US parallels that witnessed when small molecule generic competition first emerged, but remains confident that biosimilars will gain traction. The executive also sees little need for separate interchangeability studies.
FDA Holds Zydus Cadila Responsible For ‘Repeat Violations’
The FDA has published details of a warning letter summarizing significant violations of cGMP regulations to Zydus Cadila. The agency called the company’s prior response “insufficient.”