Indoco Remedies Limited (“Indoco”) announced today that its Clinical Research Organisation, AnaCipher, located at Hyderabad, has completed its 5-day comprehensive USFDA inspection. The on-site inspection was conducted from 3rd March, 2025 to 7th March, 2025, by investigators from Bioresearch Monitoring Program (“BIMO”) and Office of Study Integrity & Surveillance (“OSIS”) of USFDA.
The inspection covered both clinical & bioanalytical phases of three Bioavailability and Bioequivalence (BA/BE) studies submitted by clients, to the US Food and Drug Administration (FDA). The facility received one Form 483 at the end of the inspection, which will be responded within the timeframe.
“This is an exciting step in our journey of excellence and a validation of our adherence to applicable regulations and maintaining the highest standards in delivering quality services to our clients.” stated Ms. Aditi Kare Panandikar, Managing Director, Indoco Remedies Limited.
About AnaCipher CRO:
AnaCipher CRO, based in Hyderabad, is a USFDA inspected clinical research facility and is spread over 40,000 sq. ft area with 150-bed and staffed by experienced professionals providing clinical trial solutions and conducts Bioequivalence and Bioavailability (BA/BE) studies at its facility.
The CRO also has expertise in Bioanalytical work for new chemical entities (Phase I-III studies) for pharmaceutical companies globally. The CRO has successfully completed more than 750 studies in multiple therapeutic areas such as, cardiovascular, diabetes, oncology, anti-retrovirals and antacids.
About Indoco Remedies Limited:
Indoco is a fully integrated, research-oriented pharmaceutical company with a strong global presence. The Company’s turnover is US$ 212 million with a human capital of over 6000 employees, including over 400 skilled scientists and field staff who are the strength of the organization.
The Company has 11 manufacturing facilities, 7 for FDFs and 4 for APIs, supported by a state-of-the-art R&D Centre and a CRO facility. The facilities have been approved by most of the Regulatory Authorities including USFDA and UK-MHRA. Indoco develops and manufactures a wide range of pharmaceutical products for the Indian and international markets. It generates more than 106 million prescriptions annually from over 2,35,000 doctors belonging to various specialties. Indoco has 8 domestic marketing divisions a strong brand portfolio in various therapeutic segments including Gastro-intestinal, Respiratory, Anti-Infective, Stomatologicals, Ophthalmic, Nutritionals, Cardiovascular, Anti-Diabetics, Pain Management, Gynaecology etc. Top Indoco brands include Cyclopam, Febrex Plus, Sensodent-K, Karvol Plus, ATM, Oxipod, Cital, Sensoform, Sensodent-KF, Aloja, Glychek, Kidodent, Subitral, Rexidin, MCBM 69, Methycal, Dropizine, Noxa, Homide, Cal-Aid, etc. On the international front, Indoco has tie-ups with large generic companies across the globe.