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.
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
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.
Company is investing more than €100 million in the expansion of the Halle site
The company has received 2 observations on FDA Form 483 with respect to ANDA filed for the product to be manufactured at Indore plant.
This integrated, multi-product facility houses manufacturing suites, analytical testing laboratories and warehousing.
Sanofi will begin to ship their vaccines helping to ensure more people will be immunized
The objective of this Phase 1 study is to determine the safety and tolerability of OLX10212 in patients with advanced AMD at multiple sites in the US.
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