Roselabs Bioscience Ltd and Roselabs Polymers Ltd, a part of the Roselabs Group, on Tuesday said they have invested Rs 400 crore in setting up the pre-filled syringe making facility.

The company said that the World Health Organization-Good Manufacturing Practice (WHO-GMP) has granted its approval.

Roselabs, which commenced production six months ago, is expecting to get regulatory approvals from 35-40 countries, mainly in the emerging markets of Latin America, South East Asia and Africa by year-end, said Zameer Agarwal, Director, Roselabs Biosciences.

PFS, popular as a drug delivery system in regulated markets, is now entering the emerging markets to provide assured sterility, safety, convenience, greater accuracy, minimal over-filling, least medical waste, freedom from needle phobia and least chances of accidental needle stick injuries, he told reporters.

Annually, three million such accidents occur across the world.

The company will focus on making empty glass and polymer syringes, contract manufacturing, development of any formulation in PFS, and of customised drug delivery system and marketing formulations under its own brand name, he said, adding that Roselabs is currently marketing 26 molecules.

The Ahmedabad-based company has a capacity to manufacture eight lakh syringes daily. As of now, nearly 95 per cent of PFS are imported.

The global market for PFS is $3 billion, of which India accounts for only one per cent.

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