Regulatory Certification Details
Wanbury Limited's manufacturing facility at Tanuku, Andhra Pradesh has received the Good Manufacturing Practice (GMP) Compliance Certificate from Australia's Therapeutic Goods Administration (TGA), the regulatory authority responsible for therapeutic goods in Australia.
The certification follows a successful inspection conducted by the TGA on June 8–9, 2026, which confirmed that the manufacturing facility complies with the applicable Good Manufacturing Practice requirements outlined in the PIC/S Guide to Good Manufacturing Practice for Medicinal Products.
Product Coverage
The certificate covers the manufacturing of six Active Pharmaceutical Ingredients (APIs):
- Metformin Hydrochloride
- Tramadol Hydrochloride
- Sertraline Hydrochloride
- Diphenhydramine Hydrochloride
- Mefenamic Acid
- Paroxetine Hydrochloride Hemihydrate
Certificate Validity and Implications
The certificate was issued on October 28, 2026 and is valid until December 9, 2028, subject to the TGA's applicable re-inspection requirements.
With this approval, the TGA will proceed with issuing GMP clearances to Australian sponsors associated with the manufacturing facility, enabling the necessary regulatory clearances for the supply of the approved APIs to the Australian market.
Strategic Significance
This achievement reinforces Wanbury's focus on building globally compliant manufacturing capabilities and expanding its footprint across international markets. Recognition by Australia's TGA, a stringent regulatory authority, strengthens the company's quality credentials and its ability to serve customers and partners in regulated pharmaceutical markets.
The certification represents a significant milestone in Wanbury's journey towards operational excellence, regulatory compliance and sustainable business growth.
Company Background
Wanbury Limited was established in 1988 and is listed on the National Stock Exchange of India Ltd (Code: WANBURY) and BSE Ltd (Code: 524212). The company has a strong presence in the API global market and domestic branded formulations, with its APIs being exported to over 50 countries and having Pan-India formulation presence.
The company has USFDA & EUGMP approved facilities at Tanuku (Andhra Pradesh) and Patalganga (Maharashtra).
Product Portfolio
The API product portfolio includes Antidiabetic, Antidepressant, Pain management, Antihistamine, Anti-inflammatory, and various other products in pipeline. The company's clients include some of the leading global generic players.
In formulations, the company has a wide presence across major therapeutic categories including cough and cold solutions, gynecology, orthopedics, nutraceuticals, gastrointestinal, anti-inflammatory, and analgesics.