Wanbury Limited has received a Good Manufacturing Practice (GMP) Compliance Certificate from Australia’s Therapeutic Goods Administration (TGA) for its manufacturing facility at Tanuku, Andhra Pradesh. The certification follows an inspection conducted by the Australian regulatory authority on June 8 and 9, 2026.
The TGA confirmed that the facility complies with the applicable requirements of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products. The certificate was issued on October 28, 2026, and remains valid until December 9, 2028, subject to the regulator’s re-inspection requirements.
The approval covers the manufacture of six active pharmaceutical ingredients (APIs): Metformin Hydrochloride, Tramadol Hydrochloride, Sertraline Hydrochloride, Diphenhydramine Hydrochloride, Mefenamic Acid and Paroxetine Hydrochloride Hemihydrate.
Following the certification, the TGA will proceed with issuing GMP clearances to Australian sponsors associated with the Tanuku facility. These clearances will support the regulatory process for supplying the approved APIs to the Australian market.
The certification adds to Wanbury’s regulatory approvals and supports its plans to serve customers in international pharmaceutical markets. The company said the recognition reflects its focus on manufacturing standards and compliance with the requirements of regulated markets.
Wanbury has operations in active pharmaceutical ingredients and branded formulations. Its APIs are exported to more than 50 countries, while its formulations business has a pan-India presence. The company serves global generic pharmaceutical manufacturers and domestic healthcare markets.
Established in 1988, Wanbury is listed on the National Stock Exchange of India under the symbol WANBURY and on the BSE under code 524212. It operates manufacturing facilities at Tanuku in Andhra Pradesh and Patalganga in Maharashtra, which have approvals from the US Food and Drug Administration and the European Union’s GMP authorities.
The company’s API portfolio covers therapeutic segments including diabetes management, antidepressants, pain management, antihistamines and anti-inflammatory treatments. It is also developing additional products for its pipeline. In the formulations business, Wanbury has products across cough and cold treatments, gynaecology, orthopaedics, nutraceuticals, gastrointestinal care, anti-inflammatory medicines and analgesics.
The Australian TGA certificate provides another regulatory qualification for the Tanuku facility and is expected to support the company’s engagement with pharmaceutical customers and sponsors seeking compliant API manufacturing and supply arrangements in Australia.
