The company has entered into a binding term sheet with Stelis to acquire its Bengaluru-based Unit 3 biologics manufacturing unit, Syngene said in a late night statement on Tuesday.
The US FDA’s EIR is received for the drug-device combination to be commercialised from the Stelis Pharma's flagship facility in Bengaluru, India
Stelis Biopharma, an emerging biopharmaceutical and vaccine Contract Development and Manufacturing Organisation (CDMO) and the biologics arm of Strides Pharma, has received the European Union Goods Manufacturing Practices (EU-GMP) certification for the two manufacturing plants.
Stelis recently entered into international partnerships to manufacture biologics for diabetes, osteoporosis, and other therapeutic categories using mammalian and microbial systems from pre-clinical development through the commercialisation of biologics, biosimilars, and vaccines
Stelis Biopharma, the biopharmaceutical arm of Strides Pharma Science, said it could not sell 2.5 crore units of the single-dose vaccine manufactured by it due to several constraints following the Russian-Ukraine war.
The company's board has approved participation in the Series B fundraiser of Stelis Biopharma with a commitment of USD 15 million, Strides Pharma Science said in a regulatory filing.
"The structuring is directed towards having a sharper focus on compliance, supply chain and front-ends to provide the necessary growth impetus for its consumer facing formulations business," Strides said.
There was some regulatory overhangs post Strides-Mylan Agila transaction, says Arun Kumar, Executive VC & MD of Strides Shasun.
GMS Holding, through its subsidiary GMS Pharma (Singapore) Pte Ltd, has made a first tranche investment of USD 8.49 million in Stelis Biopharma Pvt Ltd, a subsidiary of the company, Strides Shasun said in a BSE filing.