Lincoln Pharma gets Australian health regulator nod for Gujarat plant

The certification will allow us to address the growing needs of patients in the regulated markets and provide affordable and innovative medicines, Patel stated.With the TGA EU certification, the company will expand its business network to 90 plus countries, he said.The company currently exports to 60 plus countries including East and West Africa, Central and Latin America, and Southeast Asia.

Lincoln Pharmaceuticals on Friday said Gujarat-based manufacturing facility has received approval from Australia's medicines and medical devices regulator.

The company's Khatraj (Gujarat) plant has received GMP clearance from Australia's Therapeutic Goods Administration (TGA), the drugmaker said in a statement. The certification will be valid till June 2023, it added.

Lincoln Pharma aims to enter the Australian markets soon with its dermatology, gastro, and pain management products and gradually expand its product portfolio.

The company manufactures wide range of drugs at its Khatraj facility. It produces anti-infectives and products for ailments related to the respiratory system, diabetes, dermatology among others.

The drug firm already received the European Union (EU) GMP certification which allows it to market its products in all 27 member countries.

''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,'' Lincoln Pharmaceuticals Managing Director Mahendra Patel noted.

TGA and EU GMP approvals are the results of stringent quality and compliance norms followed at Lincoln Pharma across all departments, especially the R&D and compliance, he added.

''Over the years, the company has seen good traction in the export business, which is expected to get a 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,'' Patel stated.

With the TGA & EU certification, the company will expand its business network to 90 plus countries, he said.

The company currently exports to 60 plus countries including East and West Africa, Central and Latin America, and Southeast Asia.

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