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ZIM Laboratories receives TGA GMP certification for Nagpur facility
Oct-16-2026

ZIM Laboratories has received a Certificate of Good Manufacturing Practice (GMP) Compliance from Australia’s Therapeutic Goods Administration (TGA) for its manufacturing facility at Kalmeshwar, Nagpur, Maharashtra. Issued on October 15, 2026, the certification follows an on-site inspection conducted on April 18 and April 20-21, 2026. The facility complies with the requirements of the PIC/S Guide to GMP for Medicinal Products dated August 25, 2023.

The certification covers the manufacture of non-sterile finished products across both registered and listed therapeutic goods categories. Its scope includes hard capsules, solid unit dosage forms, tablets, granules, powders for suspension, wafers and soluble films. The certification supports the company’s efforts to develop manufacturing partnerships and pursue opportunities in the Australian market, subject to applicable product-specific regulatory approvals.

Alongside supporting the company’s pursuit of opportunities in Australia, the certification is expected to strengthen the company’s credentials in Rest of World (RoW) markets. It can provide supporting GMP evidence for regulatory submissions in countries that accept or rely on TGA inspection outcomes, subject to each jurisdiction’s requirements. The Certificate is valid until June 21, 2028, subject to re-inspections being conducted as scheduled by the TGA. The certificate specifies that no further conditions apply to the manufacturing operations covered.

ZIM Laboratories manufactures, formulates, and distributes drug delivery systems to develop generic pharmaceutical products.

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