Biocon Biologics insulins facility in Malaysia receives EU GMP Certification
The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.
The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.
The capital expansion program commenced in June 2022 and is expected to complete in 2024
The integrated capabilities at Unit 2 offer significant operational flexibility, greater efficiency, and varied scope within the same premise
The company has received 1 (ONE) observation on Form 483 with respect to ANDA filed for the product to be manufactured at the said Facility.
Company is investing more than €100 million in the expansion of the Halle site
Facility features LED lighting, solar panels, automation and innovative temperature-controlled systems to maximize efficiency and minimize environmental impact
PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas administered by intravenous injection
The company is preparing the response to the observations, which will be submitted to the USFDA within 15 business days
WHO’s post EUA inspection found deficiencies in Good Manufacturing Practice at the facility
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