Drug Approval | April 18, 2022
Amneal achieves second U.S. biosimilars approval with Alymsys
Marks the second of three biosimilars Amneal expects to receive U.S. approval for in 2022
Marks the second of three biosimilars Amneal expects to receive U.S. approval for in 2022
This partnership allows both companies to become first movers to bridge an inevitable gap with the largest organizations in the pharmaceutical, nutraceutical, cosmetic, and veterinary sectors
This product will be manufactured at Lupin’s Nagpur facility in India
The drug will be manufactured at the group's injectables manufacturing facility at Jarod, Gujarat
The product will be manufactured at Lupin’s facility in Goa, India
An RMAT confers eligibility for accelerated approval and priority review of biologics licensing applications (BLA)
This product is indicated for the short-term treatment of a breathing problem (apnea) in premature infants
Lidocaine and Prilocaine Cream USP, 2.5%/2.5% has an estimated market size of US $ 29 million for twelve months ending Dec. 2021 according to IQVIA
These distinct gut microbial signatures can be used to predict the risk of developing long Covid and diagnose long Covid in patients with persistent symptoms after the acute infection
The site consists of five fermentation "mini-factories" capable of concurrently producing our more than 13 currently scaled and future bio-fermented products
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