Drug Approval | April 18, 2022
SonoScape receives USFDA 510(k) clearance for HD-550 Endoscopy system
The HD-550 endoscopy system has been available outside of the USA since 2019
The HD-550 endoscopy system has been available outside of the USA since 2019
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
Through the contract, the company will supply two key GMP intermediates for one of the 'patented drugs' of the innovator pharmaceutical customer
The minister exhorted the pharmaceutical sector to prepare a plan for the next 25 years
Under the agreement, Univar Solutions customers in Brazil and Mexico will have access to Ashland's binders and disintegrants for solid dosage forms, matrix formers for modulated release drugs and coatings for regular and modulated release solid dosage forms
The product will be manufactured at Lupin’s facility in Goa, India
The US $600 million acquisition will see Juniper Biologics offer the world's first cell-mediated gene therapy to an estimated 300 million patients in Asia Pacific, Middle East and Africa
An RMAT confers eligibility for accelerated approval and priority review of biologics licensing applications (BLA)
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