Zim Laboratories’ Nagpur plant receives Australia’s TGA GMP certification

ZIM Laboratories Limited has told the exchanges that it received a Certificate of Good Manufacturing Practice (GMP) Compliance from Australia’s Therapeutic Goods Administration (TGA) for its manufacturing facility at B-21/22, MIDC Area, Kalmeshwar, Nagpur, Maharashtra. The certificate was issued on 15 Oct 2026 and the company announced it on 16 Oct 2026.

The certificate follows an on-site inspection on 18 April and 20 to 21 April 2026. It confirms that the facility complies with the PIC/S Guide to Good Manufacturing Practice for Medicinal Products dated 25 Aug 2023.

It covers the manufacture of non-sterile finished products, both registered and listed therapeutic goods. The scope includes hard capsules, solid unit dosage forms, tablets, granules, powders for suspension, wafers and soluble films.

The company says the certification supports its efforts to develop manufacturing partnerships and pursue opportunities in the Australian market, subject to product-specific regulatory approvals. It adds that the certificate could serve as supporting GMP evidence for regulatory submissions in other countries that accept or rely on TGA inspection outcomes, subject to each country’s requirements.

The certificate is valid until 21 Jun 2028, subject to re-inspections scheduled by the TGA, and specifies that no further conditions apply to the manufacturing operations it covers.

Inference

The GMP certificate confirms that the Nagpur facility meets the manufacturing standard Australia’s regulator applies, and the company says it supports manufacturing partnerships and opportunities in the Australian market. The filing makes this subject to product-specific regulatory approvals, so the certificate does not by itself allow any product to be sold there.

The certificate is valid until 21 Jun 2028, subject to TGA re-inspections. The filing gives no figures on expected orders or revenue from the certification. How much it adds to the company’s business will depend on the partnerships and approvals that follow, which the filing does not describe.