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Results For "APL-Healthcare"

9 News Found

APL Healthcare’s Unit-IV classified as VAI by the USFDA
News | March 14, 2026

APL Healthcare’s Unit-IV classified as VAI by the USFDA

This inspection is now closed


Briefs:  APL Healthcare, Biocon, USFDA, Sun Pharma and Clean Fino-Chem
Drug Approval | December 20, 2025

Briefs: APL Healthcare, Biocon, USFDA, Sun Pharma and Clean Fino-Chem

USFDA determines Sun Pharma's Baska facility inspection classification as OAI


Briefs: Caplin Steriles, Zydus  and APL Healthcare
Drug Approval | September 20, 2023

Briefs: Caplin Steriles, Zydus and APL Healthcare

Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients


USFDA completes inspection at APL HealthCare
Drug Approval | January 19, 2023

USFDA completes inspection at APL HealthCare

The company has been issued ‘Form 483’ with two observations


Aurobindo Pharma receives USFDA nod for generic Tofacitinib tablets
Drug Approval | June 05, 2026

Aurobindo Pharma receives USFDA nod for generic Tofacitinib tablets

Approval for generic version of Xeljanz enables immediate launch and strengthens Aurobindo’s U.S. portfolio with its 586th ANDA approval


Aurobindo Pharma wins key FDA nod for $138M US cough drug market entry
Drug Approval | April 20, 2026

Aurobindo Pharma wins key FDA nod for $138M US cough drug market entry

The drug is designed to provide temporary relief from cough caused by throat and bronchial irritation


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


Briefs: Aurobindo Pharma and Granules Pharmaceuticals
Drug Approval | December 20, 2023

Briefs: Aurobindo Pharma and Granules Pharmaceuticals

Granules Pharmaceuticals gets 5 observations from USFDA on completion of GMP inspection