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Zydus signs patent licensing agreement with Takeda for 'VaultA’ in India
News | July 19, 2024

Zydus signs patent licensing agreement with Takeda for 'VaultA’ in India

The pooled prevalence of GERD in the Indian population is 15.6 %


Kwality Pharmaceuticals receives DIGIMED approval for generic, injectable and OSD
Drug Approval | July 19, 2024

Kwality Pharmaceuticals receives DIGIMED approval for generic, injectable and OSD

Kwality Pharma already has registration of 20 molecules from the units and 20 are under registration


Unichem gets 5 observations from USFDA for Goa formulation facility
Drug Approval | July 17, 2024

Unichem gets 5 observations from USFDA for Goa formulation facility

The inspection closed with five observations which were more of procedural changes with none of these related to data integrity


Mankind Pharma signs agreement with Takeda to commercialize Vonoprazan in India
News | July 17, 2024

Mankind Pharma signs agreement with Takeda to commercialize Vonoprazan in India

Vonoprazan is a potassium-competitive acid blocker (P-CAB) used for the treatment of acid-related disorders


Suven Pharmaceuticals gets Form 483 from with two observations from USFDA for Casper Pharma
Drug Approval | July 14, 2024

Suven Pharmaceuticals gets Form 483 from with two observations from USFDA for Casper Pharma

The company will address these observations within the stipulated timeline


Alembic announces USFDA tentative approval for Selexipag for Injection, 1,800 mcg/vial
Drug Approval | July 14, 2024

Alembic announces USFDA tentative approval for Selexipag for Injection, 1,800 mcg/vial

Selexipag is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension


7th India-Japan medical product regulatory symposium held at New Delhi
Policy | July 14, 2024

7th India-Japan medical product regulatory symposium held at New Delhi

Enhanced collaboration under the Memorandum of Cooperation (MoC) between India and Japan in medical product regulations


Lupin receives EIR from USFDA for its Dabhasa  facility
Drug Approval | July 13, 2024

Lupin receives EIR from USFDA for its Dabhasa facility

The facility is a part of Lupin Manufacturing Solutions


Alembic Pharmaceuticals announces USFDA Final Approval for Bromfenac Ophthalmic Solution, 0.07%
Drug Approval | July 10, 2024

Alembic Pharmaceuticals announces USFDA Final Approval for Bromfenac Ophthalmic Solution, 0.07%

The approved ANDA is therapeutically equivalent to the reference listed drug product