FDA - News

The PCI team never stops innovating. Stay informed about our latest achievements.

PCI Synthesis Identifies Trends Affecting the Generic Drugs Sector in 2019

Tags: API Manufacturing | CDMO | cGMP | FDA | GDUFA | Press Releases

Posted December 11, 2018
Easing Process Validation Rules for Small-Volume Manufacturers Might Be First Step in Easing Drug Shortages

Tags: API Manufacturing | Blog | CDMO | DMFs | Drug Shortage | FDA

Posted December 3, 2018
Easing Process Validation Rules for Small-Volume Manufacturers

Tags: API Manufacturing | Blog | CDMO | DMFs | FDA

Posted November 19, 2018
Tighter Restrictions for Drug Approval Around the World Requires a Collaborative Approach

Tags: Blog | CDMO | EMA | FDA

Posted October 29, 2018
Ensuring Smooth Sailing When It Comes to FDA Inspections

Tags: API Manufacturing | Blog | CDMO | cGMP | FDA

Posted July 2, 2018
cGMP Manufacturing for Pharma Foods Available from PCI Synthesis, Now Also a Certified Food Manufacturer

Tags: Blog | cGMP | FDA | Pharma Food

Posted February 22, 2018
PCI Synthesis Identifies Trends Affecting the Generic Drugs Sector in 2018

Tags: cGMP | FDA | Medical Polymers | Press Releases

Posted December 18, 2017
Synthetic GMP azelaic acid for derm treatments OR Synthetic GMP azelaic acid speeds regulatory approval for dermatology therapeutics

Tags: API Manufacturing | Azelaic Acid | Blog | Chemistry | EMA | FDA | Generic Drug Manufacturing

Posted November 16, 2017
Dealing with the Unexpected in API Development

Tags: Blog | FDA | Impurities | Project Management | Research and Development | Technology Transfer

Posted July 30, 2017
Are your choosing the right raw materials suppliers for your API? Successful commercialization depends on it.

Tags: Articles | cGMP | FDA | How to select a CMO | Pharmaceutical Outsourcing

Posted July 24, 2017