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Indoco Remedies successfully completes USFDA inspection of CRO Anacipher in Hyderabad


Indoco Remedies successfully completes USFDA inspection of CRO Anacipher in Hyderabad

“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.

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“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.

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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


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