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Set Alert for Manufacturing

Data Integrity Guidance Adds Focus On Culture, Best Practices And APIs

In response to comments, US FDA’s final guidance on data integrity further refines and expands on some of the principles and best practices espoused in the draft version to help pharmaceutical manufacturers counter a growing problem with inaccurate data. This problem continues to consume a good deal of FDA’s GMP enforcement efforts.
United States Manufacturing Quality

Latest From Manufacturing

GDP Failings A Public Health Risk, Says UK Inspector

Despite a succession of steps to improve the API supply chain, the UK regulator still finds may instances of non-compliance with good distribution practice.

Distribution Manufacturing

FDA’s Revised Draft For Compounding Pharmacies Opens Door To Compounding For Office Use

FDA’s revised draft guidance on GMPs for outsourcing pharmacy compounding operations responds to calls to allow the compounding of small quantities of drugs presumably for office use. The IACP applauds the move.
United States Manufacturing

Warnings Up As US FDA Trims List Of Uninspected OTC Drug Manufacturers

Hundreds of foreign firms making OTC drugs marketed in US had not been inspected for GMPs compliance before FDA Safety and Innovation Act pointed agency toward crossing those facilities off its list. Of the foreign OTC facilities inspected between June 2016 and Jan. 9, 2018, 25% received "official action indicated" inspection results, driving warning letters and import alerts.

Consumer Enforcement

New Russian Quality Assurance Rules Could Push Up Costs & Delay Product Launches

New rules aimed at tightening quality control on medicines that are to be introduced in Russia next year are expected to help prevent low-quality drugs getting to the market. However, they will bring some additional costs for pharmaceutical companies. It is also being suggested they could lead to delays in product launches.

Regulation Russian Federation

US FDA Warning Letter Hits Huahai For Failure To Prevent Valsartan Contamination

Zhejiang Huahai should have realized its valsartan API was tainted by the probable carcinogen NDMA, FDA says in warning letter, despite earlier statement from agency leadership to the contrary.

Enforcement Manufacturing

Counter-Intuitive Thinking To Combat Drug Shortages

Search for solutions to chronic drug shortages may require policymakers to push for payment policies that run counter to the current drug pricing themes, like retrofitting US Medicare’s New Technology Add-On Payments to apply to old, off-patent therapies.
Generic Drugs Manufacturing
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