Australian regulator approves Lincoln Pharmaceuticals’ Gujarat plant for GMP

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 formulation manufactured by the company, a company statement notified.

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, it added.

It also said that 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.

Speaking in this regard, Mahendra Patel, Managing Director, 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 and 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.”