Lincoln Pharmaceuticals has received approval from Australia's medicines and medical devices regulator - Therapeutic Goods Administration {TGA) for its manufacturing facility in Khatraj, Gujarat.  

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 the German FDA for its manufacturing facility which allows the company to market its products in all the 27 member countries of EU and also provide access to European Economic Area (EEA) countries.

The company manufactures wide range of drugs at its Khatraj facility and includes anti-infective, respiratory, gynaecology, dermatology, gastro, pain management, cardio & CNS, anti-bacterial, anti-diabetic, anti-malaria among others.

Mahendra Patel, Managing Director, Lincoln Pharmaceuticals said, "TGA and EU GMP approval will help expansion in more regulated markets. TGA and EU GMP approvals are a result of stringent quality and compliance norms followed at Lincoln Pharma across all departments especially in 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 begin. The certification will allow us to address the growing needs of patients in the regulated markets and provide affordable and innovative medicines."

The company has made rapid strides in pharma exports. From 11 per cent of the total sales in FY13 to 65 per cent of the total sales in FY21, the company has grown significantly. For FY21, the company’s exports grew by 18.4 per cent to Rs 270 crore.

"For the next phase of growth, the company is building a strong portfolio in lifestyle and chronic segment especially dermatology, gastro and pain management to complement its strong presence in the acute segment. Going forward, we are confident to improve our growing numbers of revenue, margins and profitability in FY22. Our strategic growth initiatives, product and geographical expansion, operational efficiency and debt-free status are likely to maximise value for all stakeholders in the near to medium term," said Patel.