Lincoln Pharma gets EU GMP nod for Khatraj facility

Lincoln Pharmaceuticals Ltd has received the European Union (EU) GMP certification from Germany FDA for its manufacturing facility located at Khatraj in Gujarat.

The certification will unlock greater market access for the company and allow it to sell its products in all the 27 member countries of EU and also give access to the European Economic Area (EEA) countries.

Company looks to enter the EU markets very soon with its dermatology, gastro and pain management products and gradually expand product portfolio, a statement said here.

The inspection was done by the regulatory agency in December 2019 followed by final approval in May.

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

Mahendra Patel, Managing Director, said, “The approval is valid for all three departments Tablet, Capsule and Cream & Ointment, which will cover wide range of Pharmaceutical Formulation manufactured by the company. EU GMP approval is the result of stringent quality and compliance norms followed at Lincoln Pharma across all departments especially the R&D and compliance. The certification will allow us to address the growing needs of patients in the EU markets and provide affordable and innovative medicines.”

With the EU certification in place, the company will expand its business network to over 90 countries. Company currently exports to more than 60 countries including East & West Africa, Central & Latin America and South-East Asia and has got many product registrations in these countries.

Company’s export business has shown sustained increase over the past decade with its share in total sales for 2019-20 going up to 61 per cent from 11 per cent in fiscal 2010-11.

“Over the years, company has seen good traction in the export business, which is expected to get further boost once EU operations begins. 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 acute segment. Strategic growth initiatives, EU approval, new product approvals, better margin products along with operational efficiency are likely to contribute healthy growth and maximise value for all stakeholders in the near to medium term,” said Patel.