Drug Approval | October 30, 2022
USFDA issues Form 483 for Parawada unit of Laurus Labs
The observation is procedural in nature and the company will address the observation within stipulated timelines.
The observation is procedural in nature and the company will address the observation within stipulated timelines.
Ketorolac Tromethamine Tablets are indicated to relieve moderately severe pain, usually after surgery.
The CRL did not identify any outstanding scientific issues with the product.
Micafungin for Injection had annual sales of US $99 million in the United States according to IQVIA data
The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.
Roflumilast Tablets had annual sales of US $248 million in the United States according to IQVIA data
For the last ten financial years, the company has posted healthy performance with its revenue from operations growing at 15% CAGR and net profit at 23% CAGR
Valbenazine Capsules had annual sales of US $781 million in the United States according to IQVIA data
Availability of pharmaceutical-grade materials with broad API compatibility key to advancing drug delivery solutions
Dr. Reddy’s largest manufacturing facility in Bachupally, Hyderabad, joins Global Lighthouse Network of the World Economic Forum
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