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Results For "compliance"

605 News Found

Aarti Drugs receives EIR from USFDA for Tarapur API facility
Drug Approval | December 26, 2024

Aarti Drugs receives EIR from USFDA for Tarapur API facility

This facility is considered to be in a minimally acceptable state of compliance with regard to current GMP


ANVISA inspection received from Brazil Health Regulatory Agency at Wanbury Tanuku facility
Drug Approval | December 21, 2024

ANVISA inspection received from Brazil Health Regulatory Agency at Wanbury Tanuku facility

The company will receive GMP compliance certificate which will further help to accelerate the business growth across the globe


Rusan Pharma achieves GMP approvals from TGA (Australia) and ANVISA (Brazil) for its manufacturing facility in Kandla SEZ
Drug Approval | December 17, 2024

Rusan Pharma achieves GMP approvals from TGA (Australia) and ANVISA (Brazil) for its manufacturing facility in Kandla SEZ

The TGA approval marks a pivotal step in Rusan Pharma’s expansion into the Australian market


CuraTeQ Biologics receives positive opinion for biosimilar Zefylti
Drug Approval | December 14, 2024

CuraTeQ Biologics receives positive opinion for biosimilar Zefylti

Zefylti will be available as 30 MU/0.5 mL and 48 MU/0.5 mL and is intended for the treatment of neutropenia and the mobilisation of peripheral progenitor cells


Supriya Lifescience expands global footprint with Esketamine Hydrochloride approval
News | December 09, 2024

Supriya Lifescience expands global footprint with Esketamine Hydrochloride approval

Esketamine hydrochloride is a vital drug to be used for treating mental illness and is likely to significantly impact the LATAM market


Granules India update on USFDA inspection at Gagillapur facility
News | December 05, 2024

Granules India update on USFDA inspection at Gagillapur facility

Granules has undertaken a proactive, voluntary and comprehensive remediation plan to address the six form 483 observations raised by the USFDA


Wanbury Q2 FY25 revenue at Rs. 161.2 crore, up 11.6%
News | November 16, 2024

Wanbury Q2 FY25 revenue at Rs. 161.2 crore, up 11.6%

EBITDA for the quarter is Rs. 21.6 crore as against Rs. 18.1 crore in Q2 FY24


NABH integrates FOGSI’S maternal health standards across its certification programs
News | November 15, 2024

NABH integrates FOGSI’S maternal health standards across its certification programs

The MoU signed in 2022 has progressed and culminated in the subsumption of FOGSI-led Manyata initiative’s 20 quality standards across NABH’s Certification programs


Divyesh Maru appointed CFO of Hester Biosciences
People | November 13, 2024

Divyesh Maru appointed CFO of Hester Biosciences

He specializes in financial planning, audit, compliance and ERP implementation, with extensive experience in leading automation and risk management projects