Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Caraco Feels The Sting Of FDA's Accelerated Response To GMP Violations

Executive Summary

FDA's fast action to seize drug products and ingredients at three Michigan facilities owned by Caraco Pharmaceutical Laboratories could reflect pressure from Reps. John Dingell and Bart Stupak to tighten controls on generic manufacturers

You may also be interested in...

U.S. FDA Seizes 33 Products From India's Sun-owned Caraco Detroit Site

MUMBAI - U.S. FDA toughened its stand on generic drug maker Caraco, ordering it to immediately stop distributing its drugs until the agency had assurance that the firm had complied with its good manufacturing practices

U.S. FDA Nails Ranbaxy On Charges Of Falsifying Data; Halts All Application Reviews From Paonta Sahib Plant

MUMBAI - India's largest drug maker Ranbaxy received a body blow after the U.S. Food and Drug Administration initiated a new regulatory action against the company's Paonta Sahib-based manufacturing plant in India. The drug regulator halted review of drug applications from the manufacturing plant due to evidence of falsified data and invoked the Application Integrity Policy

After Ranbaxy, U.S. FDA Hauls Up Caraco Pharma for QC Issues; May Withhold Future Drug Approvals

MUMBAI - U.S. FDA issued a warning letter to Caraco Pharmaceuticals, a subsidiary of India's Sun Pharmaceuticals, after the drug regulator found quality control lapses at its Detroit facilities, Curaco announced Nov. 3. U.S. FDA said the QC lapses conflicted with the company's standard operating procedures

Related Content





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts