Gland Pharma receives USFDA approval for Angiotensin II Acetate injection
Gland Pharma secures 180-day exclusivity for Angiotensin II Acetate Injection following USFDA approval
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Browsing Tag
Abbreviated New Drug Application (ANDA
What US FDA’s new surprise foreign inspections plan means for India
Pharma companies exporting to the US should now rightly be on guard and start preparing for the inevitable “knock on the factory…
Lupin receives US FDA approval for generic Tolvaptan Tablets
Company secures 180-day marketing exclusivity as first-to-file applicant for bioequivalent to Jynarque
Alembic Pharmaceuticals secures US FDA approval for Pantoprazole Sodium Injection
Regulatory clearance enables Alembic to launch generic equivalent of Protonix I.V. in the US market
IPA questions FAERS data interpretation in the Ohio State University study
The Indian Pharmaceutical Alliance (IPA) states that a higher rate of serious adverse events (SAEs) for drugs manufactured in…
Lupin receives U.S. FDA approval for generic Ipratropium Bromide nasal spray
Approval allows marketing of generic equivalent of Atrovent Nasal Spray in the U.S.
Lupin and Natco secure US FDA approval for generic Bosentan tablets for oral suspension
Natco receives first-to-file exclusivity for Bosentan Tablets for Oral Suspension, 32 mg, in the US market
Lupin receives tentative FDA approval for generic Darunavir combination tablets
It will be manufactured at Lupin’s Nagpur facility in India
Lupin secures FDA approval for generic Emtricitabine and Tenofovir Alafenamide tablets
Lupin to launch generic version of Descovy with 180-day exclusivity, targeting HIV treatment market
Granules Pharmaceuticals gains U.S. FDA approval for Lisdexamfetamine Dimesylate chewable tablets
New approval supports treatment for ADHD and binge eating disorder while addressing critical drug shortages