Drug Approval | July 08, 2022
Dr. Reddy's Laboratories updates on PAI of formulations facility
The company has been issued a Form 483 with two observations which the company will address within the stipulated timeline.
The company has been issued a Form 483 with two observations which the company will address within the stipulated timeline.
This GMP and Pre-Approval Inspection is part of the routine business operations and the company shall submit to US FDA within the stipulated timeline
The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
These medicines have low risk of hypoglycemia, provide beta cell protection, offer cardio-renal benefits and are safe for patients with kidney or liver conditions and senior citizens
Site Enhances New Modality CRDMO Platform Capacity for Customers
Medicfibers in collaboration with AIIMS New Delhi, has developed an antimicrobial solution Viroclog that when applied as a coating on textiles, provides long-lasting protection against HAI by reducing virus, bacteria, fungi survival on fabric
The new facility will be delivered through an investment of approximately CHF 500 million and is expected to be completed in 2026
This is the 142nd ANDA (including 8 tentative approvals received) out of Eugia Pharma Specialty Group (EPSG) facilities, manufacturing both oral and sterile specialty products.
It includes both public and private health facilities including hospitals, clinics, diagnostic laboratories, and imaging centers
Company is investing more than €100 million in the expansion of the Halle site
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