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 Wilson’s disease. Over the past several years, Chemoswed has developed, scaled up, and validated an efficient process for manufacturing high quality, cGMP compliant WTX101. The sponsor recently reported highly promising results from a 24–week clinical phase II study in patients newly diagnosed with Wilson’s disease.
Jonas Hansson, CEO, commented “We are extremely pleased with the results from this Phase 2 study. We believe that WTX101 may have the potential to improve treatment options for patients with Wilson Disease, a life-long disease for which there has been no innovation for decades.”
Dr Lars Olsson, VP CMC, said “I have enjoyed our collaboration with Chemoswed, which has been very smooth and successful. They have taken on the challenge of developing our rather unusual active ingredient with enthusiasm, transparency, and proficiency. We are well positioned for commercial manufacturing.”
Dr Carl Andersson, marketing manager at Chemoswed, noted “All along we have been excited by the opportunities that WTX101 offer. We congratulate our friends at Wilson Therapeutics on an important milestone”
Renewed Japanese GMP accreditation
The Japanese Ministry of Health, Labour and Welfare has renewed Chemoswed’s accreditation as foreign drug manufacturer. This certification is valid for a period of five years, enabling continued export of our commercial range of active pharmaceutical ingredients into Japan. Additionally, Chemoswed is awarded cGMP certificates issued by the Swedish Medicinal Products Agency as well as the United States Food and Drug Administration.
Chemoswed receives CEP approval for benserazide HCl
It is officially announced that Chemoswed now holds a CEP for benserazide hydrochloride, the latest addition to it’s commercial range of products. Further supported by various ASMF filings, this product is now available in stock for immediate supply of Ph. Eur. grade material. Chemosweds current list of commercial API’s comprises:
Warfarin sodium, Ph Eur
Melperone hydrochloride, E-DMF
Isradipine, Ph Eur, USP
Amantadine sulfate, DAC
Benserazide hydrochloride, Ph Eur
Chemoswed acquired by Magle AB
As of January 1st, 2016, Chemoswed is a part of the Magle Chemoswed group. Magle has successfully developed a number of interesting and unique products both in the medtech and pharmaceutical sectors, that has led to a substantial out-licensing and partnering agreements. Magle Chemoswed’s mission is to combine the strength of our expertise, experience and innovation in the industries of active pharmaceutical ingredients, medical devices and pharmaceuticals and provide innovative and affordable solutions that improve patient outcomes. More information is available at our homepage, maglechemoswed.com.
Chemoswed announces that commercial scale manufacture of benserazide hydrochloride has now been established in the main plant. The necessary regulatory filings, EDMF and CEP, have been made with the relevant authorities. This latest addition to Chemoswed’s commercial line of products is applied in a fixed dose combination with L-dopa, serving to minimise systemic side effects in Parkinson’s disease patients. Said Carl Andersson, marketing manager at Chemoswed: “benserazide represents a great business opportunity for us on a pretty poorly supported generics market. While benserazide hydrochloride is rather demanding from a process point of view, our development over the last few years has established a product of superior quality which we are keen to offer to European customers at competitive prices.”
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 by the US Food and Drug Administration during a week-long onsite inspection. The outcome of the audit was very positive, and no form 483 observation was issued. Gunnar Johansson, head of QA at Chemoswed, said that: “the entire crew here should be very proud of their operational conduct and strong focus on high quality manufacturing – a successful inspection from one of the most demanding agencies provides great support for our claim to be a reliable partner for API manufacturing”.
Renewed GMP Certificate.
Following inspections which took place late 2014, Chemoswed has received an updated certificate of GMP compliance. The certificate was issued by the Swedish Medical Products Agency, and covers all manufacturing facilities, i. e. kilolab, pilot plant, and the main manufacturing plant. The certificate is valid for three years. Copies are made available to customers requiring such for regulatory purposes.
Chemoswed becomes Chemoswed.
It has been broadly announced, that DuPont made a decision to separate the Performance Chemicals segment, creating two strong, independent companies by mid-2015. While Chemoswed will remain part of Performance Chemicals, our legal entity changed it’s name from DuPont Sverige AB into Chemoswed AB, effective January 1, 2015. Apart from the name change, there is no impact on our operations. Our company registration and VAT numbers will remain the same, but all business communications should be addressed to Chemoswed AB.