Two India Firms In Fresh FDA Trouble: Emcure Hit By Warning Letter, Dr Reddy’s Gets 483
Executive Summary
The US regulator has slammed India’s Emcure Pharmaceuticals in a warning letter, accusing the company of slipshod investigation of tests showing microbial contamination and poor supervision, and has also sent a Form 483 containing eight observations to Dr Reddy’s.
You may also be interested in...
Emcure Aims To Split Itself In Half
By the middle of next year, Emcure intends to have demerged its operations in highly developed markets from its activities in India and other emerging markets. The Indian group is seeking private-equity support to grow inorganically in North America and Europe.
The Next New Thing In FDA Inspections: Poor Root Cause Investigations
Data integrity failures are so yesterday. Now it’s all about poor investigations into out-of-specification results.
Generic Price-Fixing Lawsuit Grows As More Companies, Two Executives Named Defendants
US state attorneys general name executives from Mylan and Emcure as defendants, and list may further expand as investigation continues into additional companies and drugs.