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Solara Active Pharma Sciences' Cuddalore facility completes EU GMP Inspection

Solara Active Pharma Sciences' Cuddalore facility completes EU GMP Inspection

Solara Active Pharma Sciences, a leading Active Pharmaceutical Ingredient / CRAMS company, announced the successful completion EU-GMP Inspection, carried out jointly by the State Institute for Drug Control (SUKL), Ministry of Health of the Czech Republic and National Authority of Medicines and Health Products (INFARMED), Portugal from February 7 to 9, 2023, at the multi-product manufacturing facility at Cuddalore.

At the end of the inspection, it is concluded that the Quality Systems followed at our Cuddalore site are compliant to the EU GMP Standards.

The Cuddalore facility has also completed the inspection carried out by the World Health Organization (WHO) between January 23 - 26, 2023.

Jitesh Devendra, MD, Solara Active Pharma Sciences commented, We are happy with the successful outcome of two consecutive regulatory inspections, EU-GMP and WHO-GMP inspections at our Cuddalore facility. The result of these inspections demonstrates our commitment to regulatory excellence at our global manufacturing sites. We stay committed to a high degree of compliance across Solara's manufacturing network.

The Cuddalore multi-product API manufacturing facility was established in the year 1991 and is equipped with appropriate infrastructure to include several independent production blocks and related packaging sections. This site is inspected by various Regulatory Authorities including US FDA, MHRA, EDQM, WHO, PMDA, TGA, KFDA, and COFEPRIS.

More news about: quality / gmp | Published by Sudeep Soparkar | February - 15 - 2023 | 289

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