Solara gets European Approval (CEP) to manufacture Ibuprofen from its flagship Vizag facility

1 Nov 2022 , 12:17 PM

Solara Active Pharma Sciences Limited (Solara), a leading pure play Active Pharmaceutical Ingredient provider has announced that its new state of the art multipurpose API manufacturing facility at Vishakhapatnam, Andhra Pradesh, had received ‘Certificate of Suitability’ (CEP) approval for the manufacture of Ibuprofen API, from European Directorate for the Quality of Medicines (EDQM), the first international regulatory approval for this new facility.

With this key approval, Solara has CEP approval for two manufacturing facilities for Ibuprofen API, the other being its dedicated manufacturing facility located at Puducherry, India.

Solara also expects series of other international regulatory approvals for its Vizag facility, including USFDA.

Commenting on the CEP approval, Jitesh Devendra, MD said “We are very happy to announce the CEP approval of Ibuprofen for our Vizag facility. With this, we can offer Ibuprofen to our customers in Europe from our Vizag facility and our current Pondicherry facility. The timing of approval is in line with the demand of Ibuprofen normalizing to its original levels further strengthening Solara’s leadership position in the regulated markets.

In addition to Ibuprofen API, we have commenced validation of new API’s to be filed from Vizag in the next few quarters for various regulated markets which will result in offsetting the under recoveries.

Vizag site plays a pivotal role in our long-term growth strategy. We remain committed towards this effort.”

At around 12:20 PM, Solara Active Pharma Sciences Ltd is currently trading at Rs412 per share up by Rs14.35 or 3.61% from its previous closing of Rs397.65 per share on the BSE.

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