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Results For "approval"

2604 News Found

Orbicular's partner secures tentative U.S. ANDA approval for a generic version of Ozempic
Drug Approval | April 21, 2026

Orbicular's partner secures tentative U.S. ANDA approval for a generic version of Ozempic

OneSource is the contract development and manufacturing organization (CDMO) partner for this product


Rusan Pharma secures Japan PMDA GMP approval for API, FDF facilities
News | April 20, 2026

Rusan Pharma secures Japan PMDA GMP approval for API, FDF facilities

PMDA is regarded among the most stringent regulatory bodies globally


CDSCO reforms cut trial approval timelines by over 50%: DCGI Dr Rajeev Raghuvanshi
Drug Approval | April 14, 2026

CDSCO reforms cut trial approval timelines by over 50%: DCGI Dr Rajeev Raghuvanshi

Outlines 1,500-member internal cadre, digital regulatory system, and faster SEC-led reviews


Shalby Hospitals gets 5-year kidney transplant approval for Ahmedabad Krishna Unit
Hospitals | April 14, 2026

Shalby Hospitals gets 5-year kidney transplant approval for Ahmedabad Krishna Unit

The license is valid for five years, effective from April 9, 2026


Glenmark gets USFDA approval for generic Endometrin vaginal inserts
Drug Approval | April 09, 2026

Glenmark gets USFDA approval for generic Endometrin vaginal inserts

Final approval for progesterone vaginal inserts expands Glenmark’s women’s healthcare portfolio in the US, targeting a market of over $59 million


IndiaAI, CDSCO launch hackathon to accelerate health innovation approvals
Digitisation | April 08, 2026

IndiaAI, CDSCO launch hackathon to accelerate health innovation approvals

AI challenge offers Rs 10 lakh top prize and potential ?50 lakh deployment contract; applications open till April 17


Aurobindo gets USFDA approval for Dapagliflozin with 180-day exclusivity
Drug Approval | April 08, 2026

Aurobindo gets USFDA approval for Dapagliflozin with 180-day exclusivity

Immediate U.S. launch planned for Farxiga®-equivalent diabetes drug; opportunity pegged at $10.2 billion in annual market size


Aurobindo Pharma wins USFDA approval for generic Xigduo XR
Drug Approval | April 08, 2026

Aurobindo Pharma wins USFDA approval for generic Xigduo XR

Immediate U.S. launch planned for dapagliflozin-metformin ER tablets; addressable market estimated at $514 millionannually


Zydus gets USFDA final approval for generic Dapagliflozin with 180-day shared exclusivity
Drug Approval | April 08, 2026

Zydus gets USFDA final approval for generic Dapagliflozin with 180-day shared exclusivity

Immediate opportunity in the $10.2 billion U.S. market as the diabetes therapy will be manufactured at Zydus’ SEZ Ahmedabad facility


Marksans Pharma receives USFDA approval for Benzonatate capsules
Drug Approval | April 02, 2026

Marksans Pharma receives USFDA approval for Benzonatate capsules

Benzonatate is a non-narcotic antitussive that numbs stretch receptors in the respiratory tract