Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 213

Results For "NDA"

3709 News Found

LPU organizes conference on welfare of global community
News | November 27, 2022

LPU organizes conference on welfare of global community

Joint Drugs Controller (India) Dr PBN Prasad shared his views about working during harsh COVID-19 pandemic days


AstraZeneca receives import and market permission from CDSCO for Dapagliflozin
Drug Approval | November 26, 2022

AstraZeneca receives import and market permission from CDSCO for Dapagliflozin

The receipt of this permission paves way for the launch of Dapagliflozin (Forxiga) tablets of 10 mg in India for the specified additional/expanded indication, subject to the receipt of related statutory approvals


CPHI Frankfurt 2022: Global pharma confidence hits record high in CPHI Pharma Index
News | November 26, 2022

CPHI Frankfurt 2022: Global pharma confidence hits record high in CPHI Pharma Index

In fact, the overall CPHI Pharma Index – a collateralised metric of all major ranking categories – has risen by more than 8%, the largest year-on-year gain in the survey’s six year history


USFDA inspects Lupin's Mandideep Unit-1 facility
News | November 25, 2022

USFDA inspects Lupin's Mandideep Unit-1 facility

The inspection of the facility resulted in issuance of a Form-483 with eight observations each for the Drug Product facility and API facility at the site


USFDA issues warning letter to Glenmark's Goa manufacturing facility
News | November 24, 2022

USFDA issues warning letter to Glenmark's Goa manufacturing facility

The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility


Zydus receives final approval from USFDA for Famotidine Injection
News | November 24, 2022

Zydus receives final approval from USFDA for Famotidine Injection

Famotidine Injection is indicated to treat ulcers of the stomach and intestines and to prevent intestinal ulcers from coming back after they have healed


Evive enters license agreement with Acrotech Biopharma to commercialize Ryzneuta in US
News | November 24, 2022

Evive enters license agreement with Acrotech Biopharma to commercialize Ryzneuta in US

Ryzneuta is a novel dimeric G- CSF long-acting fusion protein without pegylation. The Biologics License Application (BLA) of Ryzneuta is currently under late-stage review by the US FDA for Chemotherapy-Induced Neutropenia (CIN)


Ministry of Ayush announces setting up of Academic Chair at Western Sydney University
News | November 23, 2022

Ministry of Ayush announces setting up of Academic Chair at Western Sydney University

It will undertake academic and collaborative research activities in Ayurveda, including herbal medicine and yoga, as well as design academic standards, short-term/medium-term courses, and educational guidelines


USFDA grants priority review of BLA for dengue vaccine TAK-003
Drug Approval | November 23, 2022

USFDA grants priority review of BLA for dengue vaccine TAK-003

If approved, TAK-003 has the potential to become an important dengue prevention option for healthcare providers


Alembic receives USFDA final approval for Nifedipine Extended-Release Tablets
Drug Approval | November 22, 2022

Alembic receives USFDA final approval for Nifedipine Extended-Release Tablets

Nifedipine Extended-Release Tablets have an estimated market size of US $56 million for twelve months ending September 2022