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605 News Found

Lupin receives USFDA nod for Famotidine injection
Drug Approval | May 15, 2026

Lupin receives USFDA nod for Famotidine injection

Famotidine Injection USP is a generic version of Pepcid injection to be manufactured at its Nagpur facility for the U.S. market


Alembic Pharma receives USFDA tentative approval for Darolutamide tablets
Drug Approval | May 15, 2026

Alembic Pharma receives USFDA tentative approval for Darolutamide tablets

Darolutamide Tablets, 300 mg, had an estimated market size of US$ 3,155 million in the United States


JB Chemicals reports muted Q4 FY26 as integration resets business
News | May 12, 2026

JB Chemicals reports muted Q4 FY26 as integration resets business

The CDMO segment saw a 22% decline in Q4 due to a strong base in the prior year


Caplin Steriles receives USFDA approval for Calcium Gluconate Injection
Drug Approval | May 06, 2026

Caplin Steriles receives USFDA approval for Calcium Gluconate Injection

Fresenius Kabi's approved generic therapy addresses acute symptomatic hypocalcemia and targets a US market valued at nearly $71 million


Lupin receives USFDA approval for generic Ravicti oral liquid
Drug Approval | May 05, 2026

Lupin receives USFDA approval for generic Ravicti oral liquid

Approval expands Lupin’s specialty portfolio in the US market for treatment of urea cycle disorders


Dr Reddy’s becomes first to secure Health Canada nod for generic Semaglutide injection
Drug Approval | May 01, 2026

Dr Reddy’s becomes first to secure Health Canada nod for generic Semaglutide injection

Market authorization for generic GLP-1 therapy strengthens company’s diabetes portfolio in Canada


Alembic announces FDA final approval for Fingolimod capsules
Drug Approval | April 27, 2026

Alembic announces FDA final approval for Fingolimod capsules

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Gilenya Capsules, 0.5 mg of Novartis Pharmaceuticals Corporation (Novartis)


Cipla wins USFDA nod for first generic of Ventolin HFA strengthening respiratory push
Drug Approval | April 27, 2026

Cipla wins USFDA nod for first generic of Ventolin HFA strengthening respiratory push

The approval makes Cipla’s product the first AB-rated generic therapeutic equivalent of Ventolin HFA


Cipla’s generic Ventolin HFA secures USFDA approval
Drug Approval | April 23, 2026

Cipla’s generic Ventolin HFA secures USFDA approval

Approval for Albuterol Sulfate inhalation aerosol enables Cipla Limited to enter the $1.5 billion U.S. albuterol market