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    Indoco Remedies successfully completes USFDA inspection of CRO Anacipher in Hyderabad

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2019-08-13T09:45:22+05:30  |  Updated On 16 Aug 2021 4:23 PM IST

    "This is the fourth successive USFDA inspection with ZERO 483 for our CRO – AnaCipher," stated Ms Aditi Kare Panandikar, Managing Director, Indoco Remedies Limited.


    Mumbai: Indoco Remedies Ltd. announced today that it's Clinical Research Organisation, Anacipher, located at Hyderabad had undergone a walk-in surveillance inspection by the United States Food and Drug Administration (a division of New Drug Bioequivalence Evaluation) from 5th August to 9th August 2019.


    The inspection successfully concluded without any observations and no form 483 is issued.


    "This is the fourth successive USFDA inspection with ZERO 483 for our CRO – AnaCipher," stated Ms Aditi Kare Panandikar, Managing Director, Indoco Remedies Limited.


    We are committed to strict adherence to regulatory guidance and maintaining the highest standards in delivering quality services to our clients, " she added.


    The CRO - AnaCipher conducts Bio-Equivalence and Bio Availability (BA/BE) studies at its facility spread over an area of 30,000 sq. ft. with 98 beds. CRO also has expertise in Bio-Analytical work for new chemical entities (Phase I-III studies).


    Read Also: Indoco Remedies receives EIR from USFDA for sterile, solid dosages facility in Goa


    Headquartered in Mumbai, the company is a fully integrated, research-oriented pharma company with presence in 55 countries. It has 9 manufacturing facilities, 6 of which are for FDFs and 3 for APIs, supported by a state-of-the-art R&D Centre and a CRO facility.


    The facilities have been approved by USFDA, UK-MHRA, TGA-Australia, MCC-South Africa, etc. Indoco develops and manufactures a wide range of pharmaceutical products for the Indian and international markets. It generates more than 70 million prescriptions annually from around 3,10,000 doctors belonging to various specialities.


    Indoco has 9 domestic marketing divisions with a strong brand portfolio in various therapeutic segments including Respiratory, Anti-Infective, Dental Care, Pain Management, Gastrointestinal, Ophthalmic, Cardiovascular, Anti-Diabetics, Anti Obesity, etc.


    Top Indoco brands include Cyclopam, Febrex Plus, Sensodent-K, Oxipod, Cital, ATM, Cloben-G, Sensoform, Sensodent-KF, Karvol Plus, Glychek, Kidodent, Carmicide, Bactogard, etc. On the international front, Indoco has tie-ups with large generic companies like Watson (Actavis) – the USA and ASPEN-South Africa.


    Read Also: Indoco Remedies gets USFDA warning letter for significant violations at Goa facility

    aditi kare panandikarANACIPHERClinical Research OrganisationCROIndocoIndoco RemediesIndoco Remedies Limitedpharmapharma companypharma newspharma news indiaUK MHRAUSFDAZERO 483

    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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