August 07, 2020
Tag: Exhibitor Webinar , VEC , CPHI China
Company Name: Hainan Shuangcheng Pharmaceuticals Co., Ltd.
Company Profile:Founded in 2000, Shuangcheng Pharma is an international high-tech enterprise specialized in peptide products, with integration of research & development, manufacturing and sales (both APIs and finished dosage forms). Having rich experience in manufacturing of injectable products, Shuangcheng Pharma can provide excellent CMO/CDMO services.
Shuangcheng Pharma has developed and produced products approved by foreign regulatory agencie. Among them, the marketing authorization (MA) from the Italian Medicines Agency for Thymalfasin for injection has been received in February 2017. Bivalirudin for injection, as an anticoagulant, has been approved by the U.S. FDA in October 2019. Pregabalin capsule, indicated for the neuropathic pain, has been approved by the U.S FDA in September 2019. Memantine Hydrochloride tablets, indicated for treatment of Alzheimer's type, has been approved by the U.S. FDA in April 2020. In addition, the ANDA for Eptifibatide injection, as a platelet aggregation inhibitor, has been submitted to the U.S. FDA in January 2019. At present, the drug master file (DMF) for the API of the product is "Available for Reference".
Shuangcheng Pharma has passed several inspections by NMPA and foreign Authorities, including US FDA unannounced inspection, PAI and EMA on-site inspection. All facilities for APIs and different dosage forms (peptide APIs, oral solid dosages, sterile injections and lyophilized formulations) comply with cGMP requirements.
Title:Patent Barrier? We knocked it down. Story of a peptide product entering into US market
Speaker: Vivian Chen (Head of International Business Department) ? Mellia Ju (International Business Specialist)
Position:Vivian Chen
Head of International Business Department
Vivian Chen, Head of International Business of HNSP, 9 years' experience in the pharma industry, interacting with foreign pharmaceutical companies and partners for collaborations, and with international authorities, eg. USFDA and AIFA during inspections
Mellia Ju
International Business Specialist
Mellia Ju, 5 years' experience in the pharma industry and has participated in inspections by international authorities and collaborations with foreign pharmaceutical companies.
For more information, click here to view my store.
Contact Us
Tel: (+86) 400 610 1188
WhatsApp/Telegram/Wechat: +86 13621645194
Follow Us: