Friday, 19 July 2019

Lupin positions itself to enter sterile injectables category

13 June 2019 | News

The new injectable facility in Nagpur manufactures prefilled syringes, and liquids, as well as lyophilized vials, single dose auto injectors, multi-dose pen devices, lyophilized vials.

With flexibility in both the operation and supply chain, Mumbai based multi national pharmaceutical company Lupin is now well-positioned to make their entry into the sterile injectable product category in a unique ready-to-use platform.

The injectables facility at Nagpur got commissioned in 2018. In total, Lupin has 18 manufacturing and 9 R&D sites across the globe. The manufacturing capabilities are spread across tablets, capsules, sterile and non-sterile liquids, injectable, metered dose inhalers (MDIs) and dry powder inhalers (DPIs).

The new injectable facility in Nagpur manufactures prefilled syringes, and liquids, as well as lyophilized vials, single dose auto injectors, multi-dose pen devices, lyophilized vials. Barrier isolation technology provides the enhanced containment solution during aseptic processing, and novel technologies are considered for automation of component tub and tray debagging and delidding facilitates a no-touch transfer and handling.

Exhibit batches of 3 products have been taken for advanced market from the Nagpur facility. The facility has aseptic isolators (from Skan) worth Rs 20 crore installed for prefilled syringe and vials filling.

The lyophilizer (from Telstar) is equipped with an automatic vial loading and unloading system and minimized human intervention during the lyophilization to prevent product contamination and increases the lifespan of sensitive products.

There is presence of fully automated line for syringe packing with latest technology of Denesting, Plunger Rod insertion, safety device insertion and Blister packaging, along with fully automated assembly machines for auto Injectors and pen devices from M/s Bosch – Moeller Devicon.

"We will be very soon conducting biosimilar filling also at our Nagpur facility. Besides the injectables facility, Lupin also has two blocks of Oral Solid Dosage (OSD) facility here in Nagpur. There is an investment of Rs 489 crore involved in the OSD units and Rs 264 crore for the injectables facility. The second OSD block is Lupin's most recent one and the first commercial batch was released in May 2019. We have applied new-age technologies at our Nagpur facility in order to meet our business goals", said Rajendra B. Chunodkar, President – Manufacturing Operations, Lupin. 

At present, Lupin has 6-7 biosimilars in the pipeline along with six-times expansion plans at the biosimilar facility in Pune.

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