Date: 16 October 2026

Press Release Summary

ZIM Laboratories Limited has received a Certificate of Good Manufacturing Practice (GMP) Compliance from Australia's Therapeutic Goods Administration (TGA) for its manufacturing facility located at B-21/22, MIDC Area, Kalmeshwar, Nagpur, Maharashtra.

The certification was issued on 15 October 2026 following an on-site inspection conducted on 18 April and 20-21 April 2026. It confirms that the facility complies with the requirements of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products dated 25 August 2023.

Certification Scope and Details

  • Coverage: Manufacture of non-sterile finished products across both registered and listed therapeutic goods categories
  • Dosage Forms: Hard capsules, solid unit dosage forms, tablets, granules, powders for suspension, wafers, and soluble films
  • Validity: The certificate is valid until 21 June 2028
  • Conditions: No further conditions apply to the manufacturing operations covered
  • Maintenance: Subject to re-inspections being conducted as scheduled by the TGA

Strategic Implications

  • Supports the Company's efforts to develop manufacturing partnerships in the Australian market
  • Enables pursuit of opportunities in Australia, subject to applicable product-specific regulatory approvals
  • Expected to strengthen the Company's credentials in Rest of World (RoW) markets
  • Provides supporting GMP evidence for regulatory submissions in countries that accept or rely on TGA inspection outcomes
  • Reinforces ZIM's commitment to manufacturing quality, regulatory compliance, and reliable supply
  • Provides foundation for engaging with partners across a range of pharmaceutical product requirements

Company Background

ZIM Laboratories Limited is a research-driven pharmaceutical company that develops, manufactures, and supplies differentiated generic products in oral solid dosage forms across key therapeutic segments. The Company has state-of-the-art in-house R&D capabilities and is listed on both the National Stock Exchange of India Limited (NSE) and BSE Limited.