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Hainan Shuangcheng Pharmaceuticals Co.,Ltd.
4
Years
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Company Profile of Hainan Shuangcheng Pharmaceuticals Co.,Ltd.
Basic Information
Company Name
Hainan Shuangcheng Pharmaceuticals Co.,Ltd.
Year of Establishment
2000
Enterprise Size
100-500
Company Introduction
Welcome to Shuangcheng Pharma
Founded in 2000, Hainan Shuangcheng Pharmaceuticals Co., Ltd (HNSP) is a publicly-traded company and engaged in development, manufacturing and marketing of both APIs and drug products. Having excellent know-how in peptide chemistry, HNSP is a leader in the field of peptide manufacture, with current U.S. FDA and AIFA (Italian Medicines Agency) approved production.
The company is headquartered near Haikou airport on Hainan Island, China with R&D and manufacturing facilities at the Haikou site, and is building new facilities in Ningbo, about 1.5 hours’ drive from Shanghai’s Pudong Airport (PVG). HNSP also has a subsidiary company in Italy.
HNSP is rapidly expanding in China and elsewhere around the world, and is presently seeking collabrations and partnership with pharmaceutical companies in the U.S., Europe and other regions.
Main Competitive Advantages
International Approvals/Standards,Experienced R&D Staff,Production Capacity,Large Product Line,Contract Manufacturing (CRO,CMO),Quality Service,
Postal Code
570314
Website
http://www.shuangchengmed.com
Milestone
2000
Founded;
2003
Jitai® (Thymalfasin for Injection) approved and launched in China
2004~2009
Sales maintained increasing by 50%;
2010
Acquired Hainan Weile Pharmaceuticals Co., Ltd;
2012
Initial public offering in 2012;
2013
Passed USFDA GMP inspection for peptide API facility;
2014
Establised holding subsidiary in Ningbo;
2016
Passed USFDA unannounced GMP inspection;
Passed EMA on-site inspection for sterile drug product Thymalfasin FDA & API;
2017
Received Italian MA decree for Thymalfasin for Injecion;
Passed the USFDA PAI for Bivalirudin API & FDF;
2018
Received USFDA tentative approval for Bivalirudin for Injection;
Submitted quality consistency evaluation of Thymalfasin for Injection to NMPA;
2019
US FDA unannounced GMP inspection;
Successfully challenged the patent of RLD of Bivalirudin for Injection and received US FDA final approval;
Received US FDA approval for Pregabalin Capsule;
Passed the US FDA PAI for memantine Hydrochloride Tablets
2020
Received US FDA MA approval for Memantine Hydrochloride Tablets;
Exported Bivalirudin for Injection to US
Trading Ability
Business type
Manufacturer
Main Sales Market
North America,Central/South America,Western Europe,Eastern Europe,Middle East,
R&D Capacity
Own Brand,
Contract Customization
CMO,CDMO,
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