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A Warning Letter Trend Surprise: Good In India, Bad In South Korea

Executive Summary

A comparison of US FDA inspection and warning letter rates find India performs much better than China and South Korea.

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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.

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.

FDA Warns Glenmark Over Temperature Excursions, Gritty Topicals

Firm should have addressed complaints of gritty topicals and compromised container/closures, and its own findings about overheated creams, the US FDA says.

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