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9479 News Found

Lonza completes expansion to Solid Form Services Facility at Bend (US) site
News | January 17, 2023

Lonza completes expansion to Solid Form Services Facility at Bend (US) site

New facility is based at Lonza’s Bend, Oregon (US) site, a Center of Excellence for bioavailability enhancement


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


Zydus receives tentative approval from USFDA for Levomilnacipran Extended-Release Capsules
Drug Approval | January 16, 2023

Zydus receives tentative approval from USFDA for Levomilnacipran Extended-Release Capsules

The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India


Granules India’s Gagillapur facility completes USFDA inspection
Drug Approval | January 16, 2023

Granules India’s Gagillapur facility completes USFDA inspection

The company will respond to these observations within the stipulated time period.


Govt. planning 10,000 Jan Aushadhi Kendras by March 2024
Policy | January 13, 2023

Govt. planning 10,000 Jan Aushadhi Kendras by March 2024

The implementing agency of PMBJP has invited online applications for opening of new Jan Aushadhi Kendras in 651 districts of different States/UTs


Zydus receives final approval and 180 days shared exclusivity from USFDA for Brexpiprazole tablets
Drug Approval | January 13, 2023

Zydus receives final approval and 180 days shared exclusivity from USFDA for Brexpiprazole tablets

Brexpiprazole is an atypical antipsychotic indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults


USFDA inspects Piramal Pharma Lexington facility
Drug Approval | January 12, 2023

USFDA inspects Piramal Pharma Lexington facility

The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines.


Merck named one of America’s Most JUST Companies by JUST Capital and CNBC
News | January 11, 2023

Merck named one of America’s Most JUST Companies by JUST Capital and CNBC

The JUST 100 is the only ranking that recognizes companies doing right by all their stakeholders as defined by the American public.


Lupin and Exeltis announce reimbursement approval of NaMuscla in Spain
News | January 10, 2023

Lupin and Exeltis announce reimbursement approval of NaMuscla in Spain

NDM disorders are a group of rare, inherited neuromuscular disorders with an estimated prevalence of 1 case per 100,000 inhabitants in Spain, and are characterized by the inability to relax muscles following voluntary contraction (myotonia)


Zydus receives final approval from the USFDA for Febuxostat Tablets
Drug Approval | January 10, 2023

Zydus receives final approval from the USFDA for Febuxostat Tablets

Febuxostat tablets had annual sales of USD 32 million in the United States according to IQVIA data (IQVIA MAT Sept. 2022).