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sterile apis gmp manufacturing cordenpharma

DCAT Week '17 Announcement Forum: CordenPharma Expands ...

DCAT 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 million for 2017.

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Corden Pharma International DMF, CEP, Written ...

CordenPharma International, a pharmaceutical brand of International Chemical Investors Group (ICIG), is a full-service partner in the Contract Development & Manufacturing (CDMO) of APIs, Drug Products, and associated Packaging Services.

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Q7 Good Manufacturing Practice Guidance for Active ...

Q7 Good Manufacturing Practice Guidance for Active ... This document is intended to provide guidance regarding good manufacturing practice (GMP) for ... applies to the manufacture of sterile APIs ...

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Manufacture of sterile active pharmaceutical ingredients

Active Pharmaceutical Ingredients (API’s), used as ingredients in sterile medicinal products, must be sterile unless the final dosage form is terminally sterilised, or produced by a process including a sterilising filtration step.

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Guidance for Industry, Q7A Good Manufacturing Practice ...

Sep 24, 2001· This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing ...

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CordenPharma boosts API manufacturing capacity

CordenPharma announced commercial oligonucleotide API manufacturing expansion in its Colorado (USA) facility. The expansion, which was completed in Q1 2018, will provide cGMP oligonucleotide manufacturing capacity up to 2mol, with a significant increase in total commercial capacity up to 500kg annually, making CordenPharma Colorado one of the largest oligonucleotide manufacturing sites …

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CordenPharma Adds Manufacturing Line for Vet Drug Products

CordenPharma, a contract development and manufacturing organization (CDMO) for APIs, drug products, and packaging, will invest €10 million (almost $12 million) in a new manufacturing line dedicated to producing veterinary drug products for 500-kg scale batch sizes.

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Q 7 Good Manufacturing Practice for Active Pharmaceutical ...

This document (Guide) is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality.

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CordenPharma CDMO bought API manufacturing facility from ...

CordenPharma, a leading Contract Development & Manufacturing Organization (CDMO), has entered into definite agreements to acquire the former Hospira Boulder (Colorado) high containment API …

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Questionaire for preparing GMP-inspections

II Manufacturing and testing of sterile products 29 22. Manufacture of sterile products 29 23. Aseptic processes 30 ... III Trade of active pharmaceutical ingredients (API) and excipients 37 ... processing instructions in accordance with EU GMP, the manufacturing description in accordance

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CordenPharma acquires API manufacturing site, Colorado US

CordenPharma recently acquired a highly potent API site in Boulder, US, which was previously owned by Pfizer. The new facility will be renamed CordenPharma Boulder. The site will add significant capacity to CordenPharma, adding five GMP highly potent manufacturing process trains. The site will also ...

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API Development & Manufacturing | CordenPharma

CordenPharma’s chemical development scientists have the skill and experience to meet a wide range of outsourcing needs from the custom synthesis and scale-up of an existing route, to identification and development of new manufacturing routes.

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CordenPharma International - Drug Development and Delivery

CordenPharma is your full-service partner in the Contract Development & Manufacturing (CDMO) of APIs, ... -Oral APIs-Oral & Sterile Drug Products-Primary & Secondary Packaging; Segregated . …

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Pfizer sells ex-Hospira API plant in Colorado to CDMO ...

CordenPharma will supply Pfizer with highly potent active pharmaceutical ingredients (HPAPIs) from the facility in Boulder once earmarked for closure by the Big Pharma firm. When Pfizer bought Hospira in September 2015 for $17bn (€14.4bn), it added a number of facilities to its manufacturing ...

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Good Manufacturing Practices (GMP) Guidelines for Active ...

The sterilization and aseptic processing of sterile APIs are not covered by this guidance, but should be performed in accordance with the Good Manufacturing Practices Guidelines, Edition 2009, Version 2 …

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CordenPharma Caponago sterile injectable facility gains ...

CordenPharma, the pharmaceuticals arm of the International Chemical Investors Group, has completed and has received approval for its aseptic filling line installed at its CordenPharma Caponago CDMO in Monza Brianza, Italy.

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CDMO/CMO Expansions: Tracking Capacity Additions

In 2016, Recipharm, a CDMO based in Jordbro, Sweden, invested more than EUR 1.2 million ($1.3 million) to enhance its small-scale GMP API development and manufacturing capabilities in its facility in Paderno Dugnano, Italy, by opening a new GMP kilo laboratory.

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CordenPharma Facility Passes FDA Inspection ...

Located in the proximity of the existing CordenPharma Colorado facility, Hospira Boulder produces APIs and intermediate products with specialized capabilities in small- to medium-scale highly potent and cytotoxic API manufacturing.

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CordenPharma Acquires Pfizer API Manufacturing Facility in ...

CordenPharma, 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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US FDA warns CordenPharma about Italian antibiotic API and ...

CordenPharma said it had been warned by the Food and Drug Administration (FDA) last week. The firm explained that the US regulator is concerned about deviations from current good manufacturing practices (cGMP) observed during a visit to the Sermoneta facility in May 2015.

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Corden Pharma - CMOCRO - Domain Name

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.

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GMP Publishing - GMP/cGMP (current Good Manufacturing ...

GMP/cGMP (Good Manufacturing Practice) information and regulations for pharmaceutical and API industry. GMP MANUAL provides current GMP know-how for your daily business! GMP Compliance Adviser Login; ... Sterile Manufacturing: Barrier Systems, Isolator and Safety Cabinets.

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cordenpharma.com Full-Service CMO ~ cGMP Contract ...

Description: CordenPharma is a full-service CMO for a global market linking together a legacy of expertise in the cGMP Contract Manufacturing of APIs & Drug Products in multiple facilities across Europe and the US.

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EudraLex - Volume 4 - Good Manufacturing Practice (GMP ...

EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines Volume 4 of "The rules governing medicinal products in the European Union" contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC ...

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CordenPharma Acquires Ancora Pharmaceuticals' Technology

Formed in 2006, CordenPharma is a full-service partner for cGMP Contract Development & Manufacturing (CDMO) of oral, sterile, highly potent and antibiotic pharmaceutical Drug Products and ...

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Drug Product Manufacturing | AMRI

Drug Product Manufacturing Home / Solutions / Drug Product Solutions / Drug Product Manufacturing Leverage our expertise and capabilities for your sterile drug product manufacturing needs at any scale across early clinical through large-scale commercial.

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Revision of Annex 1 "Manufacture of Sterile Medicinal ...

On 20 December, the European Commission published the long-awaited revision draft of Annex 1 "Manufacture of Sterile Medicinal Products" of the EU Guideline for good manufacturing practice for drug products and drug substances.

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Sterile Manufacturing Future Trends And Challenges ...

We anticipate that these business moves will advance the ability of contract manufacturing of sterile products to meet the technological and capacity needs of the industry, with new facilities and technology as an answer to the issue of and problems associated with aging sterile product manufacturing …

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Cleanrooms and containment guidelines and GMP

The EU GMP, PIC/S, ICH and WHO guidelines are referred to in Dr Hans Schicht's 'Regulatory Reflections' column in Clean Air and Containment Review. The UK NHS Aseptic guidance documents are interesting in that they fill some of the gaps in international ISO cleanroom standards.

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VITAL STATISTICS - beta.rodpub.com

VITAL STATISTICS Year Founded: 2006 Number of Employees: 1,500 ... €350 MM WHO WE ARE CordenPharma is your full-service CMO partner in the Contract Development & Manufacturing of APIs, Drug Products and associated Packaging Services. Through a network of fully- ... • Sterile APIs • Drug Products • Oncology – Oral Dosage Drug Products ...

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Corden Pharma : Private Company Information - Bloomberg

Nov 12, 2018· It offers API development and contract manufacturing, generic API manufacturing, highly potent APIs, sterile APIs, peptides, building blocks, …

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Peptide APIs | CordenPharma

CordenPharma is one of the leading manufacturers of peptide Active Pharmaceutical Ingredients (APIs) with an unprecedented track record of experience in supporting our customer along the value chain ranging from early clinical to commercial in worldwide markets.

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