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
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 provides anticipated impact to second quarter 2022 financial results due to recently completed business development transactions
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.
The company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe.
Submission seeks approval for the treatment of COVID-19 in both vaccinated and unvaccinated individuals at high risk
The award was presented to her during a virtual ceremony on the occasion of 8th International Day of Yoga on 21st June 2022.
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