Bafna Pharma gets a nod from Australian regulators

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Announcement Corporate
Last Updated : Jan 21 2013 | 4:48 AM IST

Receives TGA approval for manufacturing Prescription and Non-Prescription products

As a part of its expansion plans, Bafna Pharmaceuticals, (BSE Code: 532989) Chennai-based pharma company engaged in the business of manufacturing of pharmaceutical formulations of Betalactum and Non–Betalactum received the Australian Therapeutic Goods Administration (TGA) approval on manufacturing of both Prescription and Non-Prescription products in the Australian market. In a yet another milestone achieved, the dosage of prescription and non-prescription could be in forms of Tablets, Caplets & Hard Gelatine Capsules. The usage of such products could be in Therapeutic category and there are no limitations with the exception of sterile products and Beta Lactums.

Commenting on the approval, Mr. Bafna Mahaveer Chand, Chairman and MD of Bafna Pharma said, “The TGA process is among the most prestigious and we take immense pride in receiving the approval. This will further boost our plans for expanding in the Australian market and provide momentum to our already expanding business worldwide”.

Following this development, Bafna Pharma, is now amongst the few Indian Pharma Companies to get the TGA approval. Through this achievement the company foresees huge profit in the long term business in Australia.

About Bafna Pharmaceuticals Ltd:
The company has 80 products registered in UK, Sri Lanka, Ukraine, Lao, Ghana, Ethiopia, Philippians and Nigeria. The company has two manufacturing facilities. A WHO-GMP certified manufacturing facility in Madhavaram, which is a 100 percent Export oriented Unit (EOU) and an EU GMP (UK MHRA) facility at Grantlyon, Chennai. Recently the company received the Good Manufacturing Practices (GMP) approval from Ethiopia’s Drug Administration and Control Authority (DACA) for its non-betalactam facility.

The company in the month of April 2010 inaugurated its Research and Development (Formulation) (FR&D) facility, a pilot plant in Chennai. The company has secured ISO 9001: 2008 Certificate of Registration for Manufacture and Export of Pharmaceutical products. Bafna Pharma has also received EU GMP Compliances from (MHRA) Medicines and Healthcare products Regulatory Agency, U.K. This accreditation has made Bafna Pharmaceuticals the 35th facility to achieve this key recognition in India and has opened the gates for exploring markets of European Union.

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First Published: Sep 07 2010 | 7:04 PM IST

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