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Huateng Pharma's mPEG-pALD Receives FDA DMF Filing Approval
(MENAFN- Hunan Huateng Pharmaceutical Co Ltd) Changsha, China – Hunan Huateng Pharmaceutical Co., Ltd. (Huateng Pharma), a global leader in the development and production of high-quality PEG derivatives, is pleased to announce that its mPEG-pALD (20K) has successfully completed its Drug Master File (DMF) filing with the U.S. Food and Drug Administration (FDA), under DMF No. 040600. This achievement highlights Huateng Pharma’s dedication to meeting the highest regulatory standards and further strengthens its commitment to supporting the pharmaceutical industry’s research and clinical needs.
The successful DMF filing demonstrates that Huateng Pharma’s production processes and quality control systems fully comply with FDA standards. With this approval, the company is well-positioned to offer reliable, high-quality PEG products to customers worldwide, enhancing confidence in its offerings for critical research and drug development applications.
Jack Deng, CEO of Huateng Pharma, expressed his excitement about the milestone:
"We are proud to announce the completion of the DMF filing for mPEG-pALD (20K) with the FDA. At Huateng Pharma, we are committed to fully supporting our customers' research and clinical needs with high-quality, compliant PEG products. We look forward to continuing our collaborations and partnerships, contributing to advancements in drug development and improving patient outcomes."
mPEG-pALD (20K) plays a vital role in various applications, including the development of therapeutic protein drugs, biosimilars, rare disease treatments, and advanced biomedical research. Additionally, it is instrumental in nanotechnology, gene delivery systems, and the development of functional coatings, making it a versatile tool for the pharmaceutical and biotechnology industries.
With this achievement, Huateng Pharma reinforces its position as a trusted partner for pharmaceutical companies, researchers, and innovators across the globe.
Contact Information
Hunan Huateng Pharmaceutical Co., Ltd.
The successful DMF filing demonstrates that Huateng Pharma’s production processes and quality control systems fully comply with FDA standards. With this approval, the company is well-positioned to offer reliable, high-quality PEG products to customers worldwide, enhancing confidence in its offerings for critical research and drug development applications.
Jack Deng, CEO of Huateng Pharma, expressed his excitement about the milestone:
"We are proud to announce the completion of the DMF filing for mPEG-pALD (20K) with the FDA. At Huateng Pharma, we are committed to fully supporting our customers' research and clinical needs with high-quality, compliant PEG products. We look forward to continuing our collaborations and partnerships, contributing to advancements in drug development and improving patient outcomes."
mPEG-pALD (20K) plays a vital role in various applications, including the development of therapeutic protein drugs, biosimilars, rare disease treatments, and advanced biomedical research. Additionally, it is instrumental in nanotechnology, gene delivery systems, and the development of functional coatings, making it a versatile tool for the pharmaceutical and biotechnology industries.
With this achievement, Huateng Pharma reinforces its position as a trusted partner for pharmaceutical companies, researchers, and innovators across the globe.
Contact Information
Hunan Huateng Pharmaceutical Co., Ltd.
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