Lincoln Pharmaceuticals Limited has received clearance from Australia's medicines and medical devices regulator, Therapeutic Goods Administration (TGA), for its formulations manufacturing facility at Khatraj in Gujarat, which produces tablet, capsule and cream and ointment.
The approval will enable Lincoln to export its pharmaceuticals and healthcare products to the Australian markets.
Lincoln Pharma has already laid out plans for the Australian market with its dermatology, gastro and pain management products. The TGA certification for the plant will be valid till June 2023, the company informed in a regulatory filing.
In May 2020, the company had received European Union (EU) GMP certification from Germany FDA for its manufacturing facility. This granted the company access to the 27-member EU and also to European Economic Area (EEA) countries.
TGA and European Union GMP approval will strengthen the company's presence in the regulated markets.
The company manufactures a wide-range of drugs at its Khatraj facility including anti-infective, respiratory system, gynaecology, dermatology, gastro, pain management, cardio & CNS, anti-bacterial, anti-diabetic and anti-malaria.
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.”
“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,” he added.
The TGA & EU certifications open export market for Lincoln in over 90 countries. It currently exports to over 60 countries in East and West Africa, Central and Latin America and South-East Asia.
The company's export business has grown significantly over the past few years. The share of exports to overall revenues increased to 65 per cent in fiscal 2021 from 11 per cent in fiscal 2013.
Patel added that company expects the next phase of growth to be driven by a strong portfolio in lifestyle and chronic segment especially dermatology, gastro and pain management. Company has a strong presence in the acute segment.
Lincoln Pharma's Khatraj facility has certification from EU-GMP, WHO-GMP and ISO-9001: 2015. Company has developed 600 plus formulations in 15 therapeutic areas, while it has filed over 25 patent applications and so far has been granted seven patents.