Roselabs Bioscience and Roselabs Polymers, part of the Roselabs Group, have set up the first of its kind complete end-to-end pre-filled syringes (PFS) making facility near Ahmedabad. The company has already invested more than Rs 400 crores in this unique new state-of-the-art facility. It is one of the few companies in the world which offers the complete PFS solution under one roof: from manufacturing of glass and polymer PFS, all required components, to making formulations that need to be put into the injectables.
Roselabs has recently got approval from the WHO-GMP and it has also initiated the process of getting other countries’ regulatory approvals. It is expecting to get regulatory approvals from 35-40 countries spread across South East Asia, Africa and Latin America in the coming months for its new project.
Explaining the uniqueness of their composite PFS set-up, Zameer Agarwal, Director, Roselabs Bioscience said, “Pre-filled syringe (PFS) is one of the most sophisticated medical devices in today’s world. There are only a handful of players in the world who make either glass or polymer PFS and they are dependent on a few other players for supply of other components. In turn, these companies then supply these complete empty syringes to the pharma companies to get the filling done. The unique selling proposition of Roselabs is that it offers a composite PFS solution under one roof. The existing and potential market for pre-filled syringes in India and globally is huge. Nearly 95 per cent of PFS are imported into India which is one of the fastest growing markets for this sector.”
He further added that Roselabs is the only one of its kind facility in India which has commercialised eight lanes of PFS filling with dedicated individual lanes as per therapeutic segments like peptide, recombinant, hormones, biotech, ophthalmic and others, along with manufacturing of complete empty devices. It has capabilities to make both glass and polymer (Cyclic Olefin Copolymer) syringes and formulation filling facilities too.
The company will focus on making empty glass and polymer syringes, contract manufacturing, development of any formulation in PFS, development of customised drug delivery system and marketing formulations under its own brand name.
“The usage of pre-filled syringes provides multiple advantages which are crucial for any patient anywhere in the world. A PFS remains sterilised for much longer than standard syringes and there are no chances of discrepancy in the drug strength. PFS is useful in emergency situations and busy hospitals as the process of transferring a drug from vials and ampoules is eliminated. Most healthcare professionals now prefer PFS to conventional syringes as they are pre-measured and ready to use with assured sterility guarantees, and offer convenience and safety to healthcare professionals as well as patients. PFS are also easy for self-administration without any medical training for patient safety,” added Agarwal.
In case of vials and ampoules, there is over-filling of 15-25 per cent, while in case of PFS it is only 2-3 per cent, which in itself is a major saving. PFS usage also ensures that medical waste (of which syringes, vials and ampoules are a major part) is brought down by nearly 50 per cent. It is estimated that every year there are around three million accidents taking place due to needle stick injuries, and PFS cuts down this risk.
EP News Bureau – Mumbai