Lincoln Pharma’s Khatraj facility receives approval from Australian Regulator, TGA
The company looks to enter the Australian markets soon with its dermatology, gastro and pain management products and gradually expand its product portfolio
Lincoln Pharmaceuticals has received approval from Australia’s medicines and medical devices regulator – Therapeutic Goods Administration (TGA). The company’s manufacturing facility in Khatraj, Gujarat received the GMP clearance from TGA for all three departments tablet, capsule and cream and ointment, which will cover a wide range of pharmaceutical formulations manufactured by the company. The company looks to enter the Australian markets soon with its dermatology, gastro and pain management products and gradually expand its product portfolio. The certification will be valid till June 2023.
TGA and EU GMP approval will strengthen the company’s presence in the regulated markets. In May 2020, the company had received European Union (EU) GMP certification from Germany FDA for its manufacturing facility which allows the company to market its products in all the 27 member countries of the EU and also give access to the European Economic Area (EEA) countries
The company manufactures a wide range of drugs at its Khatraj facility and includes anti-infective, respiratory system, gynaecology, dermatology, gastro, pain management, cardio and CNS, anti-bacterial, anti-diabetic, anti-malaria among others.
Mahendra Patel, MD, Lincoln Pharmaceuticals, said, “TGA and EU GMP approval are important stepping stones in the journey of the company and will help to expand its presence in more regulated markets. TGA and EU GMP approvals are the result of stringent quality and compliance norms followed at Lincoln Pharma across all departments, especially the R&D and compliance. Over the years, the company has seen good traction in the export business, which is expected to get a further boost once TGA & EU operations commence. The certification will allow us to address the growing needs of patients in the regulated markets and provide affordable and innovative medicines.”
