Search Results for Capsules

Showing 1 – 7

Capsule Supplier Changes: FDA Offers an Updated Policy By Michael Mezher - Published 15 August 2016

Changing the supplier of gelatin capsules used to encase drugs constitutes a minor change, and does not require a prior approval supplement (PAS), according to a US Food and Drug Administration (FDA) policy that went into effect Monday.

Categories: News, US, FDA, Generic drugs, Prescription drugs, Manufacturing

Tags: Prior Approval Supplement, Gelatin Capsules, Supplier Change

French Regulators Suspend Catalent Manufacturing Site By Zachary Brennan - Published 16 November 2015

France’s health product regulator, l’Agence National de Sécurité du Médicament et des produits de santé (ANSM), suspended production at contract manufacturer Catalent’s softgel capsule manufacturing facility in Beinheim, France, on Friday.

Categories: News, Europe, Distribution, Drugs, Due Diligence, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy

Tags: ANSM, France, French drug regulator, Catalent, softgel capsules

Generic Drugs Should Look Similar to the Drugs They Reference, FDA Says By Alexander Gaffney, RAC - Published 18 June 2015

The US Food and Drug Administration (FDA) is recommending drugs made by generic manufacturers closely mimic the physical attributes, including the size, shape and color, of the drugs they reference.

Categories: News, US, CDER, Generic drugs, Prescription drugs, Submission and registration

Tags: Guidance, Final Guidance, RLD, Tablest, Capsules, Size, Shape, Color, Taste

South Korea Scrambles to Strengthen Import Controls as Capsules Seized Containing Human Flesh By Alexander Gaffney - Published 08 May 2012

Categories: Korea

Tags: Disturbing, Baby, Fetus, Flesh, Capsules, South Korea, Import, Latest News

After Crackdown on Counterfeits, a 'River of Pills' By Alexander Gaffney - Published 27 April 2012

Categories: China

Tags: Dumping, Pills, River, Capsules, Chromium, Counterfeit, Latest News, pharmaceutical, drug

China Probe Into Chromium-Laced Capsules Escalates, 77M Capsules Seized By Alexander Gaffney - Published 24 April 2012

Categories: China

Tags: Gel, Capsules, Gelatin, Notice, Chromium, Counterfeit, SFDA, Latest News, pharmaceutical, drug

China Finds 13 Drugs Made With Excessive Levels of Chromium By Alexander Gaffney - Published 17 April 2012

Categories: China

Tags: Capsules, Gelatin, antibiotics, Chromium, Counterfeit, SFDA, Latest News, pharmaceutical, drug