Briefs: Ami Organics and Dr. Reddy’s Laboratories
Drug Approval

Briefs: Ami Organics and Dr. Reddy’s Laboratories

Ami informs that PMDA Japan has issued Inspection Result Report declaring the Sachin facility as a Good Manufacturing Practices (GMP) compliant.

  • By IPP Bureau | September 09, 2024

Ami Organics

Ami Organics has informed about completion of Good Manufacturing Practices (GMP) inspection conducted by Pharmaceutical and Medical Devices Agency, Japan (PMDA) at Ami Organics Limited’s manufacturing facility - Unit, Sachin, Surat. Ami informs that PMDA Japan has issued Inspection Result Report declaring the Sachin facility as a Good Manufacturing Practices (GMP) compliant.

Dr. Reddy’s Laboratories

United States Food & Drug Administration (USFDA) has conducted inspection at Dr. Reddy’s Laboratories Limited API manufacturing facility (CTO-6) in Srikakulam, Andhra Pradesh. The company has received the Establishment Inspection Report (EIR). The USFDA has classified the inspection as Voluntary Action Indicated (VAI) and concluded that the inspection is "closed" under 21 CFR.

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