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Generally speaking the increasing regulatory expectations (Data integrity Elemental Impurities EU GMP: chapter 35 Annex 16 risk excipient etc) are generating additional fixed costs especially in Manufacturing and Quality Consequently the critical mass of factories becomes essential to absorb those new costs and keep competitiveness
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A sterile CMO's facilities must exhibit compliant quality management systems in routine operation which fundamentally comes from facility design influenced by sound experience of aseptic manufacturing and operation of multi product sites More recently CMO's have been touting about the assistance they have received from regulators in
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Furthermore a large lyophilizer will be installed to produce sterile lyophilized products at large batches up to 25 000 vials per batch CordenPharma's injectable manufacturing investment of more than EUR 14 million ($14 9 million) will take place in CordenPharma Caponago (IT) with targeted completion before the end of 2017
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CordenPharma has a long track record of experience in manufacturing Parenteral Sterile Solutions and Emulsions in different pharmaceutical forms such as ampoules vials and pre-filled syringes Our facilities and equipment design combined with experienced and trained personnel are pivotal for success in sterile manufacturing
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Extended knowledge acquired in Active Pharmaceutical Ingredients (APIs) Manufacturing and Control both in RD and in Legacy products sold worldwide as well as in the application of the quality standards for the manufacturing and control of the Finished Pharmaceutical Products (both sterile and not sterile) and design and development of Medical Devices Experience in
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CordenPharma - Sermoneta Italy CordenPharma received a warning letter dated May 20 2016 based on the outcome of an inspection ending May 29 2015 The firm manufactures both APIs and sterile drug product (In a 2015 press release CordenPharma announced it had received approval to manufacture clinical product at the site It did not specify
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CordenPharma provides specialised technologies that are ideal for the development and manufacturing of oral sterile highly potent and antibiotic pharmaceutical Drug Products their Active Pharmaceutical Ingredients and associated Global Supply Chain and Packaging Services
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Formed as the global pharmaceutical service manufacturing platform of International Chemical Investors Group in 2006 CordenPharma is full-service partner in the Contract Development Manufacturing (CDMO) of APIs Drug Products and associated Packaging Services Through a growing network of cGMP facilities across Europe and the USA organized under five
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Erfahren Sie mehr darber wie es ist bei Corden Pharma - A Full-Service CDMO zu arbeiten Melden Sie sich noch heute bei LinkedIn an – vllig kostenlos Entdecken Sie wen Sie bei Corden Pharma - A Full-Service CDMO kennen nutzen Sie Ihr berufliches Netzwerk und finden Sie in diesem Unternehmen eine Stelle
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This has led to more and more companies to outsource API manufacturing to such places which has the main benefit of eliminating the need to invest in highly expensive equipment and infrastructure – which on top of everything can also be complicated to install and maintain A good example can be found with AstraZeneca who manufacture 85% of
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Apr 03 2017DCAT Week '17 Announcement Forum: CordenPharma Expands Oligonucletide API and Sterile Injectables Manufacturing Capacity and the largest oligonucleotide equipment targeted for GMP manufacturing before the end of 2017 CordenPharma's overall investment in the oligonucleotide manufacturing is more than $15
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CordenPharma has entered into definite agreements to acquire the former Hospira Boulder (Colorado) high containment API site from Pfizer Inc The closing of the transaction is anticipated to occur in November 2017 Located in proximity to the existing CordenPharma Colorado facility Hospira Boulder produces Active Pharmaceutical Ingredients (APIs) and intermediate
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Oct 21 2013CordenPharma Products Technologies and Services From APIs to Drug Products CordenPharma globally supplies flexible solutions which span the entire pharmaceutical development path from RD to Commercialization The products technologies and services offered are: Generic API Development and Manufacturing Custom Synthesis for Peptide APIs
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boral concrete sell $30 million eindhovensestudentenraad Boral concrete sell 30 million boral concrete sell 30 million Record warm weather has cost about 2530 million through lower Boral reported a net loss of 212 million upon recognising 316 million of net colliery and coal will be obtained from a third party for the Berrima Cement plant with
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Formed as a pharmaceutical branch of International Chemical Investors Group (ICIG) in 2006 Corden Pharma provides specialized technologies grouped under six technology platforms that are ideal for the development and manufacturing of oral sterile highly potent and antibiotic pharmaceutical Drug Products their Active Pharmaceutical
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(SafeBridge) headquartered in Mountain View California has announced that Corden Pharma Colorado in Boulder Colorado has met the criteria established under the SafeBridge program for Potent Compound Safety Certification and has been deemed competent and proficient in the safe handling of potent active pharmaceutical ingredients (APIs) and
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CordenPharma provides specialised technologies that are ideal for the development and manufacturing of oral sterile highly potent and antibiotic pharmaceutical Drug Products their Active Pharmaceutical Ingredients and associated Global Supply Chain and Packaging Services
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Alliance Contract Pharma is a contract development and manufacturing organization (CDMO) providing contract analytical and manufacturing services to the pharmaceutical industry Our FDA and DEA registered GMP facility allows us to formulate develop and scale your drug product from pre-clinical through commercial manufacturing
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Oct 11 2017CordenPharma a contract development and manufacturing organization (CDMO) has entered into definite agreements to acquire the former Hospira Boulder high-containment API site from Pfizer the company announced in an Oct 10 2017 press release
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Corden Pharma is expanding into oligonucleotide active pharmaceutical ingredient (API) manufacturing which is supported by a growing clinical pipeline of more than 150 oligonucleotide clinical projects outlined Mimoun Ayoub PhD Director Global Peptides Oligonucleotides Lipids Carbohydrates Injectables Platforms CordenPharma at the DCAT Member Company
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11 10 2017CordenPharma a contract development and manufacturing organization (CDMO) has entered into definite agreements to acquire the former Hospira Boulder high-containment API site from Pfizer the company announced in an Oct 10 2017 press release
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The Flamma Group provides a variety of pharmaceutical services including cGMP manufacturing of APIs RSMs NCEs process RD and many other activities We also have a significant number of products that we provide to those who require materials that are of the highest of quality
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Feb 13 2014Hospira confident 'swamp is drained' as US FDA ups status of Rocky Mount GMP and quality system violations led the US Food and Drug Administration (FDA) to issue the manufacturing site with the warning in April 2010 and Hospira has since invested over $200m (€146m) in remediation efforts
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SPECIAL FEATURE – Formulation Development Manufacturing – CDMOs Offer Speed Advanced Technologies the Ability to Handle More Potent APIs Almac: Expanding GMP Service Footprints High-Potency APIs and Biologic Manufacturing Present Strong Growth Opportunities for Contract Manufacturing Organizations Frost Sullivan Sept
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