Solara Active Pharma Sciences Vizag facility gets European approval (CEP) to manufacture Ibuprofen API
Chennai: Solara Active Pharma Sciences Limited, a pure play Active Pharmaceutical Ingredient provider has announced that its new state-of-the-art multipurpose API manufacturing facility at Vishakhapatnam, Andhra Pradesh, has 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.
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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."
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Solara Active Pharma Sciences Ltd is a pure-play global API manufacturer supported by state-of-the-art R&D and manufacturing facilities. With 6 manufacturing facilities and an R&D centre, Solara offers a basket of diversified, high-value Commercial APIs and Contract manufacturing services. Its API facilities are approved by various international regulatory agencies including the USFDA, EDQM, MFDS, WHO, PMDA etc.
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