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Results For "Aurobindo-Pharma-Ltd"

26 News Found

Aurobindo Pharma Ltd gets 6 observations from USFDA for Unit VII
News | May 11, 2022

Aurobindo Pharma Ltd gets 6 observations from USFDA for Unit VII

The unit is an oral manufacturing facility at Jedcherla, Hyderabad


Apitoria Pharma receives 5 observations from USFDA for API facility
Drug Approval | August 31, 2025

Apitoria Pharma receives 5 observations from USFDA for API facility

At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported


CuraTeQ Biologics receives approval for biosimilar Dazublys from UK's MHRA
News | August 26, 2025

CuraTeQ Biologics receives approval for biosimilar Dazublys from UK's MHRA

Earlier in July 2025, Dazublys has received the marketing authorisation in the European Union from the European Commission


Briefs: Lyfius Pharma and Aurobindo Pharma
News | July 01, 2025

Briefs: Lyfius Pharma and Aurobindo Pharma

Lyfius Pharma restarts operations at Penicillin-G manufacturing facility


Aurobindo Pharma Q4 PAT falls marginally to Rs. 903 Cr
News | May 27, 2025

Aurobindo Pharma Q4 PAT falls marginally to Rs. 903 Cr

During the quarter, US formulations revenue increased by 13.5 per cent YoY to Rs. 4,072 crore


Briefs: Zydus and CuraTeQ Biologics
Drug Approval | May 14, 2025

Briefs: Zydus and CuraTeQ Biologics

CuraTeQ Biologics receives approval for biosimilar Zefylti from UK’s MHRA


CuraTeQ Biologics completes Phase 1 Pharmacokinetics study of biosimilar Denosumab
News | April 09, 2025

CuraTeQ Biologics completes Phase 1 Pharmacokinetics study of biosimilar Denosumab

This study enrolled a total of 204 healthy volunteers into three groups to compare BP16 with the reference products, Prolia, obtained from both the EU and US markets


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


Apitoria Pharma gets Form 483 with 10 observations from USFDA
Drug Approval | October 01, 2024

Apitoria Pharma gets Form 483 with 10 observations from USFDA

The observations are of procedural in nature and will be responded to within the stipulated time