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Results For "manufacture"

1574 News Found

Lupin gets tentative approval from USFDA for Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution
Drug Approval | October 13, 2023

Lupin gets tentative approval from USFDA for Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution

Lupin is exclusive first-to-file and may be eligible to receive a 180-day exclusivity period at product launch


Evonik introduces the world’s first carbon-fiber reinforced PEEK filament for 3D printed medical implants
News | October 11, 2023

Evonik introduces the world’s first carbon-fiber reinforced PEEK filament for 3D printed medical implants

Alignment of carbon-fiber can be controlled during the 3D printing process


Biocon signs commercialization agreement with Juno Pharmaceuticals in Canada
News | October 09, 2023

Biocon signs commercialization agreement with Juno Pharmaceuticals in Canada

Biocon will be responsible for obtaining regulatory approval for Liraglutide, and thereafter, for the manufacture and supply of the product in the Canadian market


Thermo Fisher Scientific expands St. Louis manufacturing for complex biologic treatments
News | October 09, 2023

Thermo Fisher Scientific expands St. Louis manufacturing for complex biologic treatments

Increased capability to produce medicines for challenging diseases including cancer


Zydus receives final approval from the USFDA for Sugammadex Single-Dose Vial
Drug Approval | October 09, 2023

Zydus receives final approval from the USFDA for Sugammadex Single-Dose Vial

Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide


Lupin receives tentative approval from USFDA for Tolvaptan Tablets
Drug Approval | October 07, 2023

Lupin receives tentative approval from USFDA for Tolvaptan Tablets

Tolvaptan Tablets (RLD Jynarque) had estimated annual sales of USD 287 million in the U.S. (IQVIA MAT August 2023)


Lonza further extends collaboration with major biopharmaceutical partner for manufacturing antibody-drug conjugates
News | October 06, 2023

Lonza further extends collaboration with major biopharmaceutical partner for manufacturing antibody-drug conjugates

The extension builds upon an existing long-term collaboration for end-to-end ADC manufacturing, including payload, monoclonal antibody (mAb) manufacturing and bioconjugation


Marksans Pharma gets USFDA approval for Esomeprazole Magnesium delayed-release capsules
Drug Approval | October 05, 2023

Marksans Pharma gets USFDA approval for Esomeprazole Magnesium delayed-release capsules

This product is bioequivalent to the reference listed drug (RLD), Nexium 24 HR Delayed- Release Capsules, 2.0mg (OTC), of AstraZeneca Pharmaceuticals


Strides receives USFDA approval for Efavirenz, Emtricitabine & Tenofovir Disoproxil Fumurate tablets
Drug Approval | October 05, 2023

Strides receives USFDA approval for Efavirenz, Emtricitabine & Tenofovir Disoproxil Fumurate tablets

The approval adds to a list of products that Strides has approved in this therapeutic category through the PEPFAR pathway taking the total to 15 products


Strides receives USFDA approval for Icosapent Ethyl capsules
Drug Approval | October 04, 2023

Strides receives USFDA approval for Icosapent Ethyl capsules

The product is bioequivalent and therapeutically equivalent to the RLD, Vascepa of Amarin