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Magle Chemoswed

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Magle Chemoswed

Magle Chemoswed is the reliable Swedish custom synthesis specialist, supplying active ingredients since 1944. With a background in Pharmacia, Chemoswed is since 1996 an independent entity within the DuPont group, offering cost-effective, turn-key solutions to API needs worldwide.We have established unparalleled experience and technology, enabling efficient development and production of quality active pharmaceutical ingredients in quantities from 100 grams to 50 tons.

Magle Chemoswed is a reliable Swedish custom synthesis specialist, supplying active ingredients since 1944.

With a background in Pharmacia, Chemoswed is since 1996 an independent entity within the DuPont group, offering cost-effective, turn-key solutions to active pharmaceutical ingredients (API) needs worldwide.

We have established unparalleled experience and technology, enabling efficient development and production of quality active pharmaceutical ingredients in quantities from 100g to 50t.

Process development, scale-up and manufacturing

Our dedicated personnel are experts in process development, scale-up, analytical chemistry, regulatory and technical challenges. We operate in meticulously maintained facilities, comprising a kilolab, and pilot and commercial production plants, with more than 30 m3 reactor capacity.

Highly potent active ingredients (HPAPI)

One of our key specialities is the handling of highly potent compounds in fully-contained manufacturing suites. At Magle Chemoswed, we place special emphasis on customer communication and project documentation.

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We strive to provide maximal transparency and foster an informal project management culture, encouraging multi-level interactions. Succinct reporting by way of weekly summaries are complemented by lucid reports and frequent teleconferences.

GMP compliant API suppliers

Cost-effective operations and services are ensured through an in-depth knowledge of most aspects of drug development and regulatory concerns, as well as an extensive professional network providing relevant, associated services.

We maintain an excellent authority, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) inspection track record, and up-to-date current good manufacturing practice (cGMP) compliance.

Contact

Magle Chemoswed
P.O.Box839
SE-201 80
Malmö
Email chemoswed@swe.dupont.com
Website: www.chemoswed.com

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Development

We have the experience and equipment to handle your customized development needs on-time and on-budget. Our laboratories, kilolab, and pilot plant are operated by skilled and experienced scientists and operators. A genuine experience from the pharmaceutical industry enables us to proactively support your development project.

We support clients in all aspects of API development, including areas such as process and analytical R&D, SHE-related issues, polymorphism and salt selection, regulatory challenges, documentation, stability studies, genotox concerns, impurity/degradant profiles, raw material sourcing, etc.Process R&DCustomized processesOur chemists in the process development team will nurse your project according to your requirements and time line.…

Production

Our laboratories offer you cost effective cGMP manufacturing of smaller quantities (gram scale) API's. The kilo lab enables us to conveniently bridge the gap between lab and pilot scale and our chemical production plant is designed for multi-purpose use in small to full scale, ranging from kilo to multi-tons.

BenchFor early clinical demandsOur laboratories offer you cost effective cGMP synthesis of smaller quantities (gram scale) API's. High flexibility and technical standards allow us to handle your project efficiently. We perform multi-step synthesis and are experts in handling high potent compounds. cGMP standards are applicable also at this scale.Kilo LabFor your clinical API demand in…

Quality Assurance

Founded on Quality.

Quality is the foundation for our work and the trust you confide in us. We have built a comprehensive ICH Q7a compliant Quality Assurance System which is continuously upgraded to meet new requirements. Good Manufacturing Practice is fostered throughout our organization.We have a dedicated organization responsible for maintenance of the quality assurance system, including review…

Quality Control

Quality in focus.

Our QC is part of the Analytical R&D. QC has the responsibility for analytical testing of raw materials, intermediates and finished products. The testing is made according to established monographs including specifications according to the relevant pharmacopoeias.Our stringent SOP system regulates the test procedures and result evaluation.Our QC lab is able to perform all modern…

Regulatory

Documents for international authorities

As a global custom synthesis specialist we will provide you with documents for regulatory filing, compiled to support the registration and marketing of your product.Our team has the knowledge and experience from different markets around the world so that they can get you exactly what you need.We provide Drug Master Files (EU and USA), the…

Regulatory Compliance, Quality Assurance and Control

Chemoswed ensures total regulatory compliance, along with quality assurance and control.

Quality assuranceQuality is the foundation for our work and the trust you confide in us. We have built a comprehensive ICH Q7a compliant quality assurance system which is continuously upgraded to meet new requirements. Good Manufacturing Practice is fostered throughout our organisation. We have a dedicated organisation responsible for maintenance of the quality assurance system,…
Quick Contact Magle Chemoswed
Quick Contact Magle Chemoswed

Oncopeptides AB enters phase III clinical trials with Ygalo® (melflufen)

Oncopeptides AB recently announced that the first patient has been dosed in the pivotal phase III study OCEAN. The study...
30th June 2017

Wilson Therapeutics reports highly successful Phase II study

Chemoswed was selected as active ingredient supplier by Wilson Therapeutics as they began developent of WTX101 for the treatment of...
31st January 2017

Chemoswed Receives CEP Approval for Benserazide HCl

Chemoswed now officially holds a CEP for benserazide hydrochloride, the latest addition to it’s commercial range of products
21st November 2016

Chemoswed Acquired by Magle AB

Chemoswed is now a part of the Magle Chemoswed group
21st November 2016

Chemoswed: Commercial Scale Manufacture of Benserazide Hydrochloride in Main Plant

Chemoswed announces that commercial scale manufacture of benserazide hydrochloride has now been established in the main plant.
21st November 2016

Chemoswed Reports Successful USFDA Audit

Chemoswed is regularly inspected and certified by the Swedish Medical Products Agency. Additionally, late last year, the facilities were audited...
21st November 2016

Chemoswed Renewed GMP Certificate

Following inspections which took place late 2014, Chemoswed has received an updated certificate of GMP compliance.
21st November 2016

Chemoswed becomes Chemoswed

It has been broadly announced, that DuPont made a decision to separate the Performance Chemicals segment, creating two strong, independent...
17th August 2015

Renewed GMP Certificate

Following inspections which took place late 2014, Chemoswed has received an updated certificate of GMP compliance. The certificate was issued...
17th August 2015

Chemoswed Extends Product Range

We now officially announce the addition of benserazide to our product portfolio.
3rd February 2014

Chemoswed Staff Contribute to the Chemical Literature

Chemoswed scientists recently contributed to the literature by authoring two different organic chemistry-oriented pieces.
3rd November 2013

Chemoswed Upgrades Production Facilities for HPAPI Handling

The Chemoswed production facility has recently been upgraded in order to further minimise open handling during the production of potent...
31st October 2012

Chemoswed Strengthens Organisation

As part of our continuing efforts to refine our organisation and improve our offering, we have created a new position,...
31st May 2012

Chemoswed Re-Certified by MPA

We have received a new GMP certificate, issued by the Swedish Medial Product Agency (MPA), based on an on-site inspection...
31st January 2012

Chemoswed to Host the 2012 Nordic Process Chemistry Forum

Chemoswed has been nominated to host the biannual process chemistry conference. The event will take place at Arild, near Malmö,...
3rd October 2011

Publication from Chemoswed Process R&D

Stereoselective Synthesis of Monoamine Reuptake Inhibitor NS9544. Org. Process Res. Dev. 2011, 15, 408-412
28th February 2011

Chemoswed Extends Analytical Offer

We have recently added staff to our Analytical Development and Quality Control department. The added capacity enables us to broaden...
30th November 2010

Chemoswed Upgrades Klolab Facilities with new Equipment

As part of our continuous effort to integrate a complete range of process development services for our customers, we have...
31st March 2010

Chemoswed Extends Analytical Capabilities

We continue to update and extend our capabilities by adding techniques and instruments which enhance our ability to accomodate customer...
28th February 2010

Chemoswed Receives GMP Approval in Japan

On November 20, 2009, Chemoswed received formal notification that our facilities and operations have been found to comply with Japanese...
2nd November 2009
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