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    • Solara Puducherry and...

    Solara Puducherry and Mangalore facilities complete USFDA Inspection with zero 483s observations

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2020-02-24T12:18:10+05:30  |  Updated On 24 Feb 2020 12:18 PM IST
    Solara Puducherry and Mangalore facilities complete USFDA Inspection with zero 483s observations

    Chennai: Solara Active Pharma Science Limited (Solara), an active Pharmaceutical Ingredient provider has announced that the US Food and Drug Administration (USFDA) has completed two successful inspections of Solara's state of the art manufacturing facilities at Puducherry and Mangalore. The inspection established that the two sites are in an "Acceptable State of Compliance" with Zero Form 483 inspectional observations from USFDA. The agency with their designated auditors inspected the two facilities from 17th to 21st February 2020.

    The Puducherry API manufacturing facility is our centre of excellence for the manufacturing of Ibuprofen and its derivative APIs. The facility was established in the year 1986 and is one of the largest Ibuprofen manufacturing sites in the world. This site is inspected by various Regulatory Authorities including USFDA, MHRA, EDQM, WHO, PMDA, TGA, KFDA, and COFEPRIS.

    Solara's multiproduct manufacturing site at Mangalore was established in 1997 and has best in class infrastructure and capabilities to produce niche high-value APIs and API intermediates. In addition to the USFDA, the site also maintains its regulatory status with other leading global agencies such as MHRA, EDQM, WHO, PMDA, TGA, KFDA, and COFEPRIS.

    Commenting on the audit outcomes, Jitesh Devendra, MD said "We are very happy with the successful Zero 483 outcome of our two sites within the same week. This continues to demonstrate our relentless focus on world-class quality and compliance, which remains a key pillar of our growth strategy. We remain agile to the increasing requirements on quality and compliance, and I am confident that we will sustain our quality culture and anchor it further."

    These inspection outcomes are Solara's fourth consecutive US FDA audit with "Zero 483s". In Dec'18, Jan'19 and Jul'19, the USFDA concluded the inspections at our facilities at Solara Research Centre(SRC), Chennai and API manufacturing sites at Ambernath and Cuddalore with zero 483s.

    Solara Active Pharma Sciences Ltd headquartered in Bengaluru, India offers a basket of diversified, high-value Commercial APIs and Contract manufacturing services in over 75 countries. It has a manufacturing base comprising five API facilities in India with approvals including the USFDA, EU GMP, KFDA and PMDA in Japan.

    Read also: Solara Active Pharma names Bharath R Sesha as new CEO

    solarausfdajitesh-devendra

    Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd

    Medical Dialogues Bureau
    Medical Dialogues Bureau

      Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in. Check out more about our bureau/team here

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