Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 19

Results For "USFDA-approval"

201 News Found

Aarti Drugs posts Q1 FY26 PAT higher at Rs. 54 Cr
News | July 21, 2025

Aarti Drugs posts Q1 FY26 PAT higher at Rs. 54 Cr

During Q1FY26, the company incurred Capex of ~Rs. 48.5 crores mainly towards capacity expansion, backward integration and finished formulation R&D


Panacea Biotec reaches settlement with Apotex
News | July 12, 2025

Panacea Biotec reaches settlement with Apotex

Apotex will also pay US$ 2.5 million upon receipt of final USFDA approval of the ANDA that is the subject of the Collaboration Agreement for Paclitaxel Protein-Bound Particles for Injectable Suspension


UFlex introduces FSSAI compliant single-pellet solution for food packaging
Packaging | June 20, 2025

UFlex introduces FSSAI compliant single-pellet solution for food packaging

UFlex is the first and only Indian company to receive USFDA approval for its technology and capacity to recycle all three materials


FDA approves Merck’s enflonsia for prevention of RSV in infants
Drug Approval | June 12, 2025

FDA approves Merck’s enflonsia for prevention of RSV in infants

Enflosina is a long-acting monoclonal antibody that provides direct protection for up to 5 months


Granules strengthens ADHD portfolio with FDA approval for Lisdexamfetamine Dimesylate capsules
Drug Approval | January 31, 2025

Granules strengthens ADHD portfolio with FDA approval for Lisdexamfetamine Dimesylate capsules

Lisdexamfetamine Dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder in adults and pediatric patients aged six years and older


USFDA inspection of Shilpa Medicare Unit VI at Bengaluru
Drug Approval | November 02, 2024

USFDA inspection of Shilpa Medicare Unit VI at Bengaluru

The inspection concluded with the issuance of Form 483 with four observations which are procedural in nature


Briefs: Zydus Lifesciences and Divi's Laboratories
Drug Approval | July 22, 2024

Briefs: Zydus Lifesciences and Divi's Laboratories

Zydus receives final approval from USFDA for its NDA Zituvimeta, extended-release tablets


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


Aurobindo to launch HIV triple combination product for children living with HIV in low and middle-income countries
News | August 17, 2023

Aurobindo to launch HIV triple combination product for children living with HIV in low and middle-income countries

Aurobindo's product is already filed with the Drugs Controller General of India (DCGI) and is expected to be approved soon