Lincoln Pharmaceuticals Ltd receives approval from Australian Regulator, TGA

Lincoln Pharmaceuticals Ltd receives approval from Australian Regulator, TGA


  • Post By : Kumar Jeetendra

  • Source:

  • Date: 09 Oct,2021

Ahmedabad, October 8, 2021: Lincoln Pharmaceuticals Limited, one of India’s leading healthcare companies has received approval from Australia’s medicines and medical devices regulator – Therapeutic Goods Administration (TGA). Company’s manufacturing facility in Khatraj, Gujarat received the GMP clearance from TGA for all three departments Tablet, Capsule and Cream & Ointment, which will cover a wide range of Pharmaceutical Formulation manufactured by the Company. Company looks to enter the Australian markets soon with its dermatology, gastro and pain management products and gradually expand its product portfolio. The certification will be valid till June 2023.

TGA and EU GMP approval will strengthen the company’s presence in the regulated markets. In May 2020, company had received European Union (EU) GMP certification from Germany FDA for its manufacturing facility which allows the company to market its products in all the 27 member countries of EU and also give access to European Economic Area (EEA) countries

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, “TGA and EU GMP approval are important stepping stones in the journey of the company and will help to expand its presence in more regulated markets. TGA and EU GMP approvals are the result of stringent quality and compliance norms followed at Lincoln Pharma across all departments, especially the R&D and compliance. Over the years, the company has seen good traction in the export business, which is expected to get further boost once TGA & EU operations commence. The certification will allow us to address the growing needs of patients in the regulated markets and provide affordable and innovative medicines.”

With the TGA & EU certification, the 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 a number of global tenders.
Export business of the company has shown remarkable growth in the last few years and had increased to 65% of total sales in FY21 from 11% of total sales in FY13. Company currently exports to 60 plus countries including East & West Africa, Central & Latin America and Southeast Asia. For the FY21, exports grew 18.4% to Rs. 270 crore.
“For the next phase of growth, the company is building a strong portfolio in the 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 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 maximise value for all stakeholders in the near to medium term,” said Mr. Patel.
Over the last 5 years, Lincoln Pharmaceuticals Ltd has delivered a robust 20% plus CAGR in profits and higher single digit growth in sales. The liquidity position of the company is on a strong foundation, supported by healthy cash accruals, no term debt and healthy return ratios. Backed by improvement in the company’s financial risk profile, steady growth in scale & margins, healthy profitability, rating agency ICRA has upgraded the company’s long-term and short-term bank facilities to A and A1 respectively.
Lincoln Pharma has a state-of-the-art manufacturing facility unit at Khatraj in Ahmedabad, Gujarat, complying with stringent international quality and compliance norms and certified by EUGMP, WHO-GMP and ISO-9001: 2015. Company has developed 600 plus formulations in 15 therapeutic areas and has a strong product/brand portfolio in anti-infective, respiratory system, gynaecology, cardio & CNS, anti-bacterial, ant-diabetic, anti-malaria among others. Company has filed 25 plus patent applications and is awarded with seven patents. Company has a strong presence in the domestic market nationally with a dedicated field force of over 600 personnel who cater to more than 30,000 doctors, chemists across the country.

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