TGA GMP Certification of Compliance granted for the Kalmeshwar manufacturing facility
Australia's TGA has granted a Certificate of GMP Compliance for the company's manufacturing facility at Kalmeshwar, Nagpur.
By ScoutQuest · · 2 min read
- Certificate Issued
- 15 October 2026
- Certificate Valid Until
- 21 June 2028
- Scope Covered
- non-sterile finished products - tablets, capsules, granules, wafers, soluble films
TGA GMP certification for the Nagpur facility
Australia's Therapeutic Goods Administration (TGA) has granted ZIM Laboratories Limited a Certificate of Good Manufacturing Practice (GMP) Compliance for its manufacturing facility at B-21/22, MIDC Area, Kalmeshwar, Nagpur, Maharashtra.
Key details of the certificate
- The certificate was issued on 15 October 2026.
- It follows an on-site inspection conducted on 18 April and 20-21 April 2026.
- It confirms the facility complies with the requirements of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products dated 25 August 2023.
- The certificate is valid until 21 June 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.
What 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.
What the company says it means
- It supports the company's efforts to develop manufacturing partnerships and pursue opportunities in the Australian market, subject to applicable product-specific regulatory approvals.
- It 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 company describes the breadth of the certified dosage forms as providing a foundation for engaging with partners across a range of pharmaceutical product requirements.
How a retail investor can read this
This is a regulatory approval for the manufacturing site. The company states it supports its efforts to develop manufacturing partnerships and pursue opportunities in Australia, and that product-specific regulatory approvals apply for those opportunities. The certificate is valid until 21 June 2028, with re-inspections as scheduled by the TGA.
About the company
ZIM Laboratories Limited describes itself as a research-driven pharmaceutical company that develops, manufactures and supplies differentiated generic products in oral solid dosage forms across key therapeutic segments, with in-house R&D capabilities offering drug delivery solutions using proprietary technology platforms. It is listed on the National Stock Exchange of India Limited (NSE) and BSE Limited.
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