Drug Approval | July 30, 2024
Dr. Reddy's receives positive CHMP opinion from EMA for its proposed Rituximab biosimilar
Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance
Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance
Shelter Pharma Limited secured an order from Berlin International Medical Co D3Cure 50 ml x 30000 pcs
Eugia Pharma Specialities receives 7 observations from USFDA for Unit II
The inspection at Unit 1 by the USFDA has been successfully completed, with no observations under Form 483
The GMP facility is equipped with state of art machinery for the needs of Global commercial requirements
This integrated, multi-product facility houses manufacturing suites, analytical testing laboratories and warehousing.
The applicants will only have to get their Good Manufacturing Practices certification validated every five years to retain their licence
The company has already embarked upon significant expansion in Turkey
The GMP certificate is valid for three years until April 2024.
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