Last Updated on November 11, 2024 by The Health Master
Indoco Remedies’ Clinical Research Organisation (CRO), AnaCipher, today cleared the US Food and Drug Administration’s (USFDA) inspection.
The CRO, located in Hyderabad, was inspected by the USFDA from 12th to 16th September 2022.
The clinical phase of inspection covered three BA/BE studies submitted by clients to the USFDA and was successfully concluded with zero 483s.
“This is the seventh successive USFDA inspection with zero 483s for AnaCipher CRO.”
In the statement, “We are committed to strict adherence to all applicable guidelines and regulations and maintaining the highest quality standards in delivering quality services to our clients,” said Aditi Kare Panandikar, Managing Director, Indoco Remedies.
Further, according to the statement, the CRO also has expertise in bioanalytical work for new chemical entities (phase I-III studies) for pharma companies globally.
USFDA issues Form 483 with 11 observation to Biocon
USFDA issues Form 483 with 2 observation to Alembic
USFDA issues Form 483 with one observation to Aurobindo Pharma subsidiary’s plant
USFDA issues Form 483 with 6 observations to Cipla
UFDA issues Form 483 to Cipla’s facility in MP
USFDA issues Form 483 with 6 observations to Sun Pharma
NPPA fixes Retail Prices of 37 Formulations: September 2022
High Court: Marketing Companies will have a right to the Trademark
Govt is in final stage to cap margins of key medicines
USFDA approves Terlipressin for injection to treat Kidney function
PCI to amend Exit Examination Regulation for Diploma in Pharmacy
USFDA gives tentative approval for Sugammadex Injection
Drug alert: 45 out of 1330 samples declared as NSQ in August 2022
Panel recommends a separate legislation for Medical Devices
Govt adds 34 drugs in NLEM – National List of Essential Medicines
Latest Notifications regarding Pharmaceuticals
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
