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Results For "Contract-development-and-manufacturing-organization"

97 News Found

USFDA conducts PAI and GMP inspection of Piramal Pharma's Sellersville facility
Drug Approval | January 16, 2023

USFDA conducts PAI and GMP inspection of Piramal Pharma's Sellersville facility

The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations


Stelis Biopharma’s CDMO partner receives approval for key ANDA from the USFDA
Drug Approval | December 29, 2022

Stelis Biopharma’s CDMO partner receives approval for key ANDA from the USFDA

The current approval is first of the many fillings made by the company's CDMO partners from the flagship facility in Bangalore


China aims to lead next bio revolution in advanced biologics, says GlobalData
News | December 15, 2022

China aims to lead next bio revolution in advanced biologics, says GlobalData

China is now focusing on establishing volume and enhancing capabilities for innovative high value drug production


Evonik and Phathom Pharmaceuticals partner to produce novel acid-blocker vonoprazan
News | October 13, 2022

Evonik and Phathom Pharmaceuticals partner to produce novel acid-blocker vonoprazan

Agreement strengthens Evonik’s track record as leading contract development and manufacturing organization (CDMO)


Piramal Pharma Solutions launches ADCelerate
News | October 13, 2022

Piramal Pharma Solutions launches ADCelerate

ADCelerate delivers Phase I appropriate antibody-drug conjugate (ADC) drug substance and drug product for Investigational New Drug (IND) submission


Dipharma receives regulatory authorization for the new line at Its cGMP pilot plant
Drug Approval | October 09, 2022

Dipharma receives regulatory authorization for the new line at Its cGMP pilot plant

The company increases its efficiency and is able to face the growing demand for its services.


SIRIO appoints Lonza’s Sara Lesina as General Manager in Europe
People | September 08, 2022

SIRIO appoints Lonza’s Sara Lesina as General Manager in Europe

Her appointment further strengthens the CDMO’s strategy to become the nutraceutical R&D hub for brands looking for agile partners with large scientific and development resources


Stelis Biopharma’s flagship facility receives EIR from USFDA
Drug Approval | September 01, 2022

Stelis Biopharma’s flagship facility receives EIR from USFDA

The integrated capabilities at Unit 2 offer significant operational flexibility, greater efficiency, and varied scope within the same premise


Ube to buy API Corp. from Mitsubishi Chemical
News | August 09, 2022

Ube to buy API Corp. from Mitsubishi Chemical

APIC is a contract development and manufacturing organization (CDMO) that offers a wide range of services such as synthetic route design, pilot manufacturing, investigational medical manufacturing, and commercial production, by making full use of integrated processes that combine organic synthesis technologies and biotechnologies it has cultivated over many years


Thermo Fisher to expand dry powder media manufacturing facility in New York
News | August 05, 2022

Thermo Fisher to expand dry powder media manufacturing facility in New York

With this expansion, the Grand Island site provides redundant capacity to support global supply of media and further extends the site’s capabilities to produce the high-quality technology and materials needed for the development and commercial manufacturing of vaccines and biologic therapies