Briefs: Dr. Reddy's Laboratories and Ami Organics
Dr. Reddy's Laboratories gets Form 483 from USFDA with 4 observations for API facility
Dr. Reddy's Laboratories gets Form 483 from USFDA with 4 observations for API facility
The company is committed to address this observation comprehensively within stipulated time
Wacker Biotech US, a wholly owned subsidiary of Wacker Chemie AG, specializes in the microbial production of pDNA
The Unit currently caters to emerging markets of Latin America and Africa with a variety of dosage forms
Eugia Pharma Specialities receives 7 observations from USFDA for Unit II
FDA has concluded that this inspection is 'closed'
The company will respond to the Warning Letter within the stipulated timelines
The regulator carried out a routine current Good Manufacturing Practices (cGMP) inspection from March 28 to April 4.
The inspection at Unit 1 by the USFDA has been successfully completed, with no observations under Form 483
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