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Results For "approval"

2609 News Found

Alembic receives USFDA final approval for Loteprednol Etabonate and Tobramycin Ophthalmic suspension
News | December 12, 2025

Alembic receives USFDA final approval for Loteprednol Etabonate and Tobramycin Ophthalmic suspension

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb


Caplin Steriles gets FDA final approval for Acetaminophen Injection, infusion bags
News | December 09, 2025

Caplin Steriles gets FDA final approval for Acetaminophen Injection, infusion bags

Acetaminophen Injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older


Lupin receives FDA’s tentative approval for Siponimod tablets
Drug Approval | December 05, 2025

Lupin receives FDA’s tentative approval for Siponimod tablets

Siponimod Tablets is indicated for the treatment of relapsing forms of multiple sclerosis


Senores Pharmaceuticals receives Philippine FDA approval for 10 products
Drug Approval | December 05, 2025

Senores Pharmaceuticals receives Philippine FDA approval for 10 products

Senores Pharmaceuticals is poised to accelerate its presence in the Asia-Pacific region


ZIM Laboratories receives CDSCO approval for Naproxen + Esomeprazole capsules
Drug Approval | December 04, 2025

ZIM Laboratories receives CDSCO approval for Naproxen + Esomeprazole capsules

Grant of Permission to manufacture and market FDC of Naproxen Delayed Release and Esomeprazole capsule (375mg/500mg + 20mg/20mg)


Cleveland Diagnostics’ IsoPSA test for prostate cancer detection gains FDA approval
News | December 03, 2025

Cleveland Diagnostics’ IsoPSA test for prostate cancer detection gains FDA approval

Now a test that offers new precision in prostate cancer detection


Lupin receives FDA approval for biosimilar Armlupeg
Biotech | December 01, 2025

Lupin receives FDA approval for biosimilar Armlupeg

Armlupeg is indicated for decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs


SMS Pharmaceutical's associate company receives FDA approval for reformulated Ranitidine
Drug Approval | November 27, 2025

SMS Pharmaceutical's associate company receives FDA approval for reformulated Ranitidine

The approval by the US FDA comes after extensive safety testing and manufacturing improvements