Paving way for its foray into the European Union (EU) markets, Ahmedabad-based Lincoln Pharmaceuticals Limited has received the EU good manufacturing practice (GMP) certification from Germany's food and drugs authority (FDA) for its Khatraj plant here.
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. With this, Lincoln Pharma looks to enter the EU markets very soon with its dermatology, gastro and pain management products and gradually expand product portfolio.
The certification came after an inspection conducted in December 2019 by the regulator. Lincoln Pharma manufactures anti-infective, respiratory system, gynaecology, dermatology, gastro, pain management, cardio & CNS, anti-bacterial, anti-diabetic and anti-malaria drugs, among others at its Khatraj plant in Ahmedabad.
The nod will help the company expand its presence in more regulated markets, said Mahendra Patel, managing director of Lincoln Pharmaceuticals Limited. The approval is valid for all three departments including tablets, capsule and cream & ointment, covering a wide range of pharmaceutical formulation manufactured by the company.
As part of 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.
With the EU certification, Lincoln Pharma company will expand its business network to 90 plus countries. The company currently exports to 60 plus countries including East & West Africa, Central & Latin America and Southeast Asia, having bagged many product registrations in these countries and also awarded with number of global tenders.
The company's export business has grown significantly over the last few years, rising to 61 per cent of total sales in FY 2019-20, up from 11 per cent in FY'11. The company has almost doubled its export turnover in FY'20 as compared to FY18, clocking 15 per cent year-on-year (YoY) growth in export at Rs. 227 crore in FY 20 as compared to Rs 197 crore in FY'19.
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.
Meanwhile, the company has filed 20 plus patent applications and awarded five patents.
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