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Results For "US-FDA"

374 News Found

Glenmark Pharma reports Q4 FY25 PAT at Rs. 346.6 Cr
News | May 24, 2025

Glenmark Pharma reports Q4 FY25 PAT at Rs. 346.6 Cr

Adjusted Profit After Tax (PAT) for the year ended March 31, 2025 was at Rs. 1,389.4 crore


Lupin receives EIR from USFDA for its injectable facility in Nagpur
Drug Approval | April 17, 2025

Lupin receives EIR from USFDA for its injectable facility in Nagpur

The EIR was issued following an inspection of the facility conducted from June 10 to June 13, 2024


Briefs: Dr. Agarwal's Eye Hospital and Apitoria Pharma
News | March 20, 2025

Briefs: Dr. Agarwal's Eye Hospital and Apitoria Pharma

Apitoria Pharma’s API manufacturing facility classified as VAI by USFDA


Briefs: Zydus, Alkem Laboratories, Alkem Medtech and Relonchem
Drug Approval | March 19, 2025

Briefs: Zydus, Alkem Laboratories, Alkem Medtech and Relonchem

Alkem Medtech to acquire 100% stake of Bombay Ortho


USFDA issues Form 483 with 3 observations to Gland Pharma's Sterile APIs unit
Drug Approval | February 27, 2025

USFDA issues Form 483 with 3 observations to Gland Pharma's Sterile APIs unit

The observations issued are neither repeated observations nor related to data integrity


USFDA classifies Aurobindo Pharma Inc's warehouse as OAI
Drug Approval | February 21, 2025

USFDA classifies Aurobindo Pharma Inc's warehouse as OAI

The USFDA has determined the inspection classification status of this warehousing facility as 'Official Action Indicated


Wockhardt’s Zaynich achieves highest-ever efficacy meeting superiority in a global, pivotal, registration- enabling Phase III study
Clinical Trials | February 03, 2025

Wockhardt’s Zaynich achieves highest-ever efficacy meeting superiority in a global, pivotal, registration- enabling Phase III study

Such combined efficacy (achieving clinical cure and microbiologic cure) of Zaynich is highest ever among all the FDA-approved novel antibiotics developed in the last more than 10 years


Lupin receives EIR from USFDA for Pithampur Unit-1 Facility with VAI Classification
Drug Approval | January 09, 2025

Lupin receives EIR from USFDA for Pithampur Unit-1 Facility with VAI Classification

The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection of the facility from September 16 to September 27, 2024