Solara is pleased to announce that the CEP for Ranitidine Hydrochloride drug substance (CEP 2001-228) has been restored by EDQM.

A revised CEP has been granted as of 1st July 2021. Ranitidine Hydrochloride is an important product for Solara and is manufactured at its Cuddalore site.

Solara had put in place robust manufacturing and quality processes to mitigate the risks of N-NitrosoDimethylamine (NDMA) formation in the Ranitidine HCL API. Subsequent submission of the pertinent data has fast-tracked the restoration of CEP by EDQM. Solara is currently the only company among Ranitidine API manufacturers to have its CEP restored.

Solara Active Pharma Sciences is a young, dynamic, entrepreneurial and customer-oriented API manufacturer. It has a legacy of over three decades and traces its origins to the API expertise of Strides Shasun Limited and the technical know-how of human API business from Sequent Scientific Limited.

The company aims at delivering value-based products while maintaining focus on customer needs. It has 140+ scientists working at two R&D centers and 6 API manufacturing facilities armed with global approvals and 2 dedicated R&D facilities.