After EU, Lincoln Pharma gets Australian approval for plant

India-based Lincoln Pharmaceuticals Ltd said it is looking forward to entering the Australian market, after Australia’s medicines and medical devices regulator – Therapeutic Goods Administration {TGA) – approved the company’s primary manufacturing plant in Khatraj, Gujarat.

The approval, said the medicine manufacturer, has been granted for all three sections, tablets, capsules and creams & ointments.

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

The certification will be valid till June 2023.

“The company looks to enter the Australian markets soon with its dermatology, gastro and pain management products and gradually expand the product portfolio,” Lincoln Pharma said in a statement.

It was in May last year that the company received European Union (EU) GMP certification from Germany FDA for the manufacturing facility. That allowed the company to market its products in all the 27 member countries of EU and also get access to European Economic Area (EEA) countries.

MD Mahendra Patel called the approvals a validation of his company’s “stringent quality and compliance norms, and said exports will get a boost once TGA & EU operations begins.

The company said it will now be able to expand its sales to over 90 countries, from 60 plus countries at present.

Most of its current markets are in East & West Africa, Central & Latin America and Southeast Asia, besides India.

The export business of the company comrpised 65% of its total sales in FY21, up from 11 % of total sales in FY13.

For the year-ended March, exports grew 18.4% to Rs. 270 crore.

Patel said 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.

“Going forward, we are confident to improve our growth 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 maximize value for all stakeholders in the near to medium term,” he claimed.

Lincoln Pharmaceuticals Ltd has been among the faster growing companies in India. Its profits have grown at an average yearly rate of over 20% in the last five years, bolstered by average yearly revenue growth in the higher single digit percentages.

The company has 600 plus formulations in the market, particularly in anti-infective, respiratory system, gynaecology, cardio & CNS, anti-bacterial, ant-diabetic, anti-malaria among others.