Lincoln Pharma gets Australian TGA’s GMP clearance for Khatraj plant

India-based Lincoln Pharmaceuticals (Lincoln Pharma) has received approval from Australia’s medicines and medical devices regulator – Therapeutic Goods Administration (TGA).

TGA granted GMP clearance to the company’s Khatraj, Gujarat manufacturing plant for the three departments — tablet, capsule, and cream & ointment. The approval will cover a wide variety of pharmaceutical formulations manufactured at the facility.

Lincoln Pharmaceuticals plans to enter Australia shortly with its pain management, dermatology, and gastro products. The Indian healthcare company also plans to expand its product portfolio gradually.

The GMP certification from the Therapeutic Goods Administration will remain valid until June 2023.

Lincoln Pharmaceuticals said that the TGA approval and the previously issued European Union (EU) GMP approval will increase its footprint in regulated markets.

The company had received the EU GMP certification for its Khatraj manufacturing plant from German FDA — Federal Institute for Drugs and Medical Devices (BfArM) in May 2020.

At its Khatraj facility, the company produces a variety of drugs, including anti-infective and respiratory system drugs, as well as gastro, pain management, cardio and CNS, antibacterial, antidiabetic, and anti-malaria drugs.

The company will be able to expand its international business network to more than 90 countries with the EU and TGA certifications.

Currently, Lincoln Pharmaceuticals exports to over 60 countries, including those in East and West Africa and Central and Latin America.

Mahendra Patel — Managing Director of Lincoln Pharmaceuticals said: “TGA and EU GMP approval are important stepping stone in the journey of the company and will help to expand its presence in more regulated markets. TGA and EU GMP approvals are result of stringent quality and compliance norms followed at Lincoln Pharma across all departments especially the R&D and compliance.

“Over the years, company has seen good traction in the export business, which is expected to get further boost once TGA & EU operations begins. The certification will allow us to address the growing needs of patients in the regulated markets and provide affordable and innovative medicines.”