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Relief Therapeutics Holding SA
/ Key word(s): Regulatory Approval
Relief Therapeutics Announces Swissmedic Approval and Operation of New Good Manufacturing Practice-Compliant Laboratory
The state-of-the-art quality control and research and development laboratory in Balerna, Switzerland is run by APR Applied Pharma Research SA, a Relief Therapeutics subsidiary
GENEVA (May 15, 2023) – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFFD, RLFTD) (Relief Therapeutics, or the Company), a biopharmaceutical company committed to delivering innovative treatment options with the potential for transformative outcomes to benefit those suffering from select specialty and rare diseases, today announced its new state-of-the-art laboratory has been audited and approved by the Swiss Agency for Therapeutic Products (Swissmedic) and meets Good Manufacturing Practice (GMP) standards. Swissmedic is the national authorization and supervisory authority for drugs and medical products and devices.
The next-generation laboratory in Balerna, Switzerland is run by Relief Therapeutics’ subsidiary APR Applied Pharma Research SA (APR) and offers a comprehensive suite of analytical and development services for internal projects and provides external clients with data and full documentation to meet current Good Manufacturing Practice (cGMP), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and international regulatory authority requirements.
“GMP compliance is a critical achievement for our laboratory, enabling us to create, safeguard and supply high-quality products to patients and healthcare providers as well as enable the future submissions of product files to regulatory authorities,” said Paolo Galfetti, chief operating officer of Relief Therapeutics and chief executive officer of APR. “Our new GMP lab is designed to meet forthcoming pharmaceutical challenges and is fully integrated with the current technical and analytical R&D capabilities, with more than 800 m2 equipped for analytical and formulation development of solid and non-solid dosage forms.”
The modern analytical laboratory is part of APR’s overall upgrade of the research and development facilities and equipment in Balerna, which now includes four new state-of-the-art high performance liquid chromatography (HPLC) systems equipped for method scouting, new analytical scales, viscometers, physical testing instruments as well as a new packaging area equipped with filling and blistering machines to pack research and development prototypes for stability studies.
“We are excited that our new GMP-compliant lab in Balerna, where innovation is driven by our experienced and highly talented employees, is now Swissmedic-approved and operational,” said Jack Weinstein, chief executive officer of Relief Therapeutics. “APR is a trusted and experienced formulator and developer, which has been validated by the breadth and quality of its contract service partners and products that have been developed over more than 30 years.”
GMP requires manufacturers to ensure their products are safe and effective and cGMP requires manufactures to employ technologies and systems that are up to date and comply with GMP regulations with systems that assure proper design, monitoring and control of manufacturing processes and facilities.
ABOUT APR APPLIED PHARMA RESEARCH SA
APR Applied Pharma Research S.A. (APR) is a wholly owned subsidiary of Relief Therapeutics, which acquired the company in June 2021. The acquisition provided a vibrant research and development organization and a foundational commercial infrastructure for future product launches as well as commercial products and clinical-stage programs that transformed Relief Therapeutics into a diversified, fully integrated, commercial-stage biopharmaceutical company. The APR team continues to utilize its proven drug development expertise with proprietary drug delivery technologies to deliver solutions for rare disease management.
ABOUT RELIEF THERAPEUTICS
Relief Therapeutics is a commercial-stage biopharmaceutical company committed to advancing treatment paradigms and delivering improvements in efficacy, safety and convenience to benefit the lives of patients living with select specialty and rare diseases. Relief Therapeutics’ portfolio offers a balanced mix of marketed, revenue-generating products, our proprietary, globally patented Physiomimic™ and TEHCLO™ drug delivery platform technologies and a highly targeted clinical development pipeline consisting of risk-mitigated assets focused in three core therapeutic areas: rare metabolic disorders, rare skin diseases and rare respiratory diseases. In addition, Relief Therapeutics is commercializing several legacy products via licensing and distribution partners. Relief Therapeutics’ mission is to provide therapeutic relief to those suffering from rare diseases and is being advanced by an international team of well-established, experienced biopharma industry leaders with extensive research, development and rare disease expertise. Relief Therapeutics is headquartered in Geneva, with additional offices in Balerna, Switzerland, Offenbach am Main, Germany and Monza, Italy. Relief Therapeutics is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFFD and RLFTD. For more information, please visit our website www.relieftherapeutics.com or follow Relief Therapeutics on LinkedIn and Twitter.
RELIEF THERAPEUTICS Holding SA
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties, and other factors, which could cause the actual results, financial condition, performance or achievements of Relief Therapeutics to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. A number of factors including those described in Relief Therapeutics' filings with the SIX Swiss Exchange and the U.S. Securities and Exchange Commission (SEC) could adversely affect Relief Therapeutics. Copies of Relief Therapeutics' filings with the SEC are available on the SEC EDGAR database at www.sec.gov. Relief Therapeutics does not undertake any obligation to update the information contained herein, which speaks only as of this date.
File: Press release
|Company:||Relief Therapeutics Holding SA|
|Avenue de Secheron 15|
|Phone:||+41 22 545 11 16|
|Listed:||SIX Swiss Exchange|
|EQS News ID:||1632375|
|End of News||EQS News Service|
12 May 2023