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Results For "process"

1577 News Found

US FDA accepts supplemental new drug application for Jardiance for adults with chronic kidney disease
News | January 23, 2023

US FDA accepts supplemental new drug application for Jardiance for adults with chronic kidney disease

The supplemental New Drug Application is based on results from the landmark EMPA-KIDNEY phase III trial


Cipla launches Cippoint
News | January 18, 2023

Cipla launches Cippoint

Point-of-Care solution to facilitate clinicians in quick and effective decision making


USFDA inspections gather pace; Indian pharma companies equipped to handle disruptions
Drug Approval | January 17, 2023

USFDA inspections gather pace; Indian pharma companies equipped to handle disruptions

The top 15 Indian pharma players have continued to experience anaemic growth in the US market over the five years ended FY22


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


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


Quantumzyme and BEC Chemicals to collaborate for green chemistry development
News | January 14, 2023

Quantumzyme and BEC Chemicals to collaborate for green chemistry development

This will give either party customers access enzyme expertise and assets, resulting in cost-effective, green processing for API manufacturing.


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


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).


Suburban Diagnostics unveils Reference Laboratory in Mumbai
Clinical Trials | January 09, 2023

Suburban Diagnostics unveils Reference Laboratory in Mumbai

The lab is also the first private lab in West India to have built its Mycobacteriology, Mycology, and Molecular Biology departments within a separate Bio Safety Level - 3 (BSL3) bio-containment lab