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Results For "compliance"

518 News Found

Gland Pharma reports Q3 FY25 revenue at Rs. 1,384 Cr
News | February 04, 2025

Gland Pharma reports Q3 FY25 revenue at Rs. 1,384 Cr

Our Q3 FY25 revenue was at Rs. 1,384.1 crore with an EBITDA of Rs. 360 crore resulting in a 26% EBITDA margin


Lupin announces closure of USFDA inspection at its Somerset facility with zero 483 observations
Drug Approval | February 03, 2025

Lupin announces closure of USFDA inspection at its Somerset facility with zero 483 observations

The inspection was carried out from January 28 to February 1, 2025


CuraTeQ Biologics receives positive opinion for biosimilar Dyrupeg from EMA
News | February 03, 2025

CuraTeQ Biologics receives positive opinion for biosimilar Dyrupeg from EMA

Dyrupeg will be available as 6 mg solution for injection in prefilled syringe and is intended for the reduction in the duration of neutropenia


OneSource receives EIR with VAI classification from USFDA for BLD facility
Drug Approval | January 29, 2025

OneSource receives EIR with VAI classification from USFDA for BLD facility

OneSource operates five cGMP facilities and has a strong track record, with 138 successful regulatory and customer audits to date by all major regulatory bodies


Granules India Q3 FY25 PAT drops 6% to Rs 118 Cr
News | January 27, 2025

Granules India Q3 FY25 PAT drops 6% to Rs 118 Cr

The company said it voluntarily paused production at the Gagillapur plant in September 2024 for risk assessment on account of the USFDA observations


USFDA classifies Biocon Biologics Johor Bahru site, Malaysia as VAI
Drug Approval | January 13, 2025

USFDA classifies Biocon Biologics Johor Bahru site, Malaysia as VAI

Biocon Biologics remains committed to global standards of quality and compliance


ZIM Laboratories and Neuraxpharm granted marketing authorization for Buprenorphine Sublingual Film in Europe
News | January 10, 2025

ZIM Laboratories and Neuraxpharm granted marketing authorization for Buprenorphine Sublingual Film in Europe

According to IQVIA, the European market for Buprenorphine-based opioid dependency treatments in 2023 surpassed USD 355 million annually


Windlas Biotech’s new injectable facility receives GMP certification
News | January 10, 2025

Windlas Biotech’s new injectable facility receives GMP certification

The certification marks a new chapter in Windlas Biotech’s growth trajectory,


Carbogen Amcis successfully completed Swissmedic inspection of its Vionnaz facility
News | January 10, 2025

Carbogen Amcis successfully completed Swissmedic inspection of its Vionnaz facility

The site’s GMP Certification has been successfully renewed


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