Enforcement Report - Week of June 21, 2023
Enforcement Report - Week of February 8, 2023
KriSan Biotech and OncoArendi Therapeutic (OAT) have entered into an agreement of API supply from Pre-IND to Phase 2.
The Union commerce ministry has recommended imposition of quantitative restrictions on the imports of isopropyl alcohol (IPA) for a period of two years under Foreign Trade (Development and Regulation) Act, 1992 to protect the domestic industry from cheap inbound shipments.
The new ISOPROPANOL unit will be based on the Roussillon platform (Isere, France), a best-in-class platform in terms of competitiveness fully committed to a low carbon energy transition.
Novartis has found itself caught up in a controversy about ingredients shipped to Syria that critics say could have been used to make sarin gas.
Enforcement Report - Week of January 3, 2018
Foshan Flying Medical Products Co., Ltd. on FDA Import Alert List For Drugs From Firms Which Have Not Met Drug GMPs
Contec’s wide range of cleaning products now includes a complete line of low endotoxin products for the most critical pharmaceutical, biopharmaceutical, life science and medical device applications. Ideal for aseptic areas in pharmaceutical production facilities, Contec’s low endotoxin presaturated wipes, dry knit and nonwoven wipes, sterile 70% isopropyl alcohol, and hydrogen peroxide solution can be used together or separately to prevent endotoxin contamination in controlled environments.
Maharashtra FDA has issued a show cause notice to a Nashik based firm for not complying to quality control protocols and good manufacturing practices. It was found during inspection that quality control officers were absent in the second and third shift and that explosive solvents like lsopropyl alcohol were stored in open space among other violations.