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Manufacturing

Set Alert for Manufacturing

FDA Will Soon Begin Alerting Generics Firms To Facility Compliance Status

US FDA's GDUFA II commitment to alert generics firms within 90 days regarding inspection results will put additional pressure on Form 483 responses, possibly starting later this year.

Manufacturing Quality BioPharmaceutical
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Latest From Manufacturing

More Questions As Biocon Pulls EU Filings For Two Biosimilars

Biocon and partner Mylan have withdrawn the European application for their biosimilar trastuzumab and pegfilgrastim in the backdrop of compliance blips at Biocon’s Indian site, raising critical questions on how soon things can be set right in an increasingly competitive scenario.

Biosimilars Manufacturing

EU Member States Taking New Steps To Tackle Drug Shortages

The EU Heads of Medicines Agencies has outlined some of the recent initiatives taken by the member states to deal with medicines shortages, including a new Dutch center and a member state coordinating initiative by the Irish regulator.

Distribution Manufacturing

Updated EU Guideline On Manufacturing Finished Dosage Forms Addresses Supply Chain Complexities

New EU guidance will help companies preparing marketing authorization applications understand what to include in Module 3 of their common technical document.

Europe Manufacturing

Consumer Health Weekly Trademark Review Aug. 8, 2017

Ccompiled from the Official Gazette of the US Patent and Trademark Office, Class 3 (Cosmetics and Cleaning Preps) and Class 5 (Pharmaceuticals) marks registered and published for opposition.

Consumer Trademarks

Zero Compliance With Indian GMP/GLP Self-Inspection Rule Prompts New DCGI Notice

The Drug Controller General of India has reissued its demand for manufacturers to comply with a new self-inspection and reporting rule and has set a deadline for them to do so.

India Manufacturing

GMP Problems Stop Canadian Firms’ Topical OTC, Homeopathic Imports

Homeolab USA’s and Cellex-C’s imports were stopped earlier in 2017 following GMP inspections at their facilities, and FDA warns that approvals for marketing of additional products in the US could be withheld until each firm is GMP-complaint. Homeolab trips up by trying to prevent FDA photography inside plant.

Consumer Manufacturing
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