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Stand: Donnerstag, 20. Sep 2018, 15:08 GMT
Hinweis: Wir verlinken hier auf fremde Seitenangebote. Für deren Inhalte und Erreichbarkeit sind wir nicht verantwortlich.
Portal Fierce Pharma Manufacturing:
- Rubius Therapeutics kicks off $155M renovation of former Alexion plant in Rhode Island
- Cambrex closes on $425M deal for dosage-form CDMO Halo Pharma
- Romania’s Polisano Pharma now under control of local rail freight group
- Chinese API maker Jiangsu Yew Pharma suspended for refusing Hungarian inspectors
- FDA finds more impurities in recalled high blood pressure drug valsartan
- Sun wins approval of glaucoma drug and its once-troubled Halol plant to produce it
- Catalent’s Cook Pharmica slapped with a Form 483 by FDA
- Regeneron continues New York expansion with $800M project, 1,500 jobs
- Cadila manufacturing facility in India gets FDA Form 483 for 5 observations
- CDMO hit with FDA warning shutters plants, files for bankruptcy
Portal Pharma Manufacturing:
- Researchers use cancer drug and antidepressants to fight untreatable 'brain-eating' infection
- Suit targets AbbieVie for alleged kickback scheme
- GSK poaches Boehringer veteran for drug development lead
- Novo lays off 400 in R&D unit
- Product Focus: Innovative Packaging Systems
- Top 6 Misconceptions About Optimizing Pharma Facilities
- Analyzing for Elemental Impurities
- Unpacking the Complexity of Biologic Drug Containment
- Teva’s highly anticipated migraine med wins approval
- Regulators find second cancer-linked chemical in recalled drug
Portal Pharma Technologist:
- Strides hamstrung by US FDA Form 483
- Allergan and Sosei suspend development on Alzheimer’s drug
- Aucta and Catalent enter commercial supply agreement
- ‘Unmerited’ hep C patent contributes to Gilead monopoly, says NGO
- Takeda to move US base to Boston
- Oncology vaccine ensured 100% survival rate in lab studies
- ‘Revamped’ MannKind secures $105m licensing deal, plans Afrezza expansion
- US FDA ups the ante against antimicrobial resistance
- Looking to the future of a safe supply chain
- Five stories that speak volumes about US generics market
Nützliche Informationsquellen:
Hinweis: Wir verlinken hier auf fremde Seitenangebote. Für deren Inhalte und Erreichbarkeit sind wir nicht verantwortlich.
EudraLex – Volume 4 Good manufacturing practice (GMP) Guidelines (e) zum Download
GMP Training – eine umfangreiche Sammlung frei verfügbarer Präsentationen
ICH Training Programme Q8, Q9 and Q10
Nützliche branchenrelevante Links:
Hinweis: Wir verlinken hier auf fremde Seitenangebote. Für deren Inhalte und Erreichbarkeit sind wir nicht verantwortlich.
FDA Home Page
FDA – Drugs
FDA – Animal & Veterinary
FDA – A Risk-Based Approach
FDA Search: Warning Letters – by Subject
FDA Search: Warning Letter – by Company
European Medicines Agency
European Commission – Public Health
European Commission – Medicinal Products for Human Use
European Commission – Medicinal Products for Veterinary Use
National Institutes of Health
Central Drugs Standards Control Organization (India)
Parenteral Drug Association (PDA)
Pharmaceutical Processing Online
The Pharma Technologist
Pharmaceutical Online
European Pharmaceutical Manufacturer Magazine
Manufacturing Chemist
International Pharmaceutical Federation
VfA, die forschenden Pharmaunternehmen
Das Patientenportal des VfA
International Federation of Pharmaceutical Manufacturers and Associations
World Drug Information Association
Pharmaceutical Research and Manufacturers of America
European Pharmaceutical Market Research Association
Portal Express Scripts Pharma
Portal Reinraum
Paul-Ehrlich-Institut