Lincoln Pharmaceuticals receives EU GMP approval

Lincoln Pharmaceuticals has received the European Union (EU) GMP certification from Germany FDA for its manufacturing facility located at Khatraj in Gujarat. The certification will allow the company to market its products in all the 27 member countries of EU and also give access to the European Economic Area (EEA) countries. The company looks to enter the EU markets very soon with its dermatology, gastro and pain management products and gradually expand product portfolio.

The inspection was done by the regulatory agency in December 2019 followed by final approval in May 2020. 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.

Mr. Mahendra Patel, Managing Director, Lincoln Pharmaceuticals Limited, said, “We are very pleased and excited to receive the EU GMP accreditation. This will be an important stepping stone in the journey of the company and will help to expand its presence in more regulated markets. 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, company will expand its business network to 90 plus countries. Company currently exports to 60 plus countries including East & West Africa, Central & Latin America and Southeast Asia and has got many product registrations in these countries and is also awarded with number of global tenders.

Export business has shown remarkable growth in the last few years. Exports have increased to 61% of total sales in FY20 from 11% of total sales in FY11. Company has almost doubled the export turnover in FY20 as compared to FY18. Export of the company stood at Rs. 227 crore in FY 20 as compared to Rs. 197 crore in FY 19, a growth of 15% Y-O-Y.

“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, 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 Mr. Patel.

Lincoln Pharmaceuticals Ltd has developed 300 plus formulations in 15 therapeutic areas and has a strong product/brand portfolio in anti-infective, respiratory system, gynaecology, cardio & CNS, anti-bacterial, anti-diabetic, anti-malaria among others. Company has filled 20 plus patent applications and is awarded five patents. Company’s manufacturing facilities fulfills the cGMP guidelines and abides with WHO, cGMP norms and are certified by WHO GMP and ISO 9001:2015 along with approvals from many Countries. Company have its strong presence in Domestic market with good strength of own field force.