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JW Pharmaceutical Receives Product Approval for Antibiotic "Ertapenem" in China

Gland Pharma of India Produces Finished Products Using JW Ertapenem Ingredient
Expansion into Asian Market Following the United States and Canada

JW Pharmaceutical announced on June 11 that a finished product using its own synthesized and manufactured antibiotic ingredient, Ertapenem, has recently received product approval from the National Medical Products Administration (NMPA) of China.


JW Pharmaceutical Receives Product Approval for Antibiotic "Ertapenem" in China JW Pharmaceutical headquarters located in Gwacheon, Gyeonggi-do. JW Pharmaceutical

This product is an injectable drug for which JW Pharmaceutical supplies the raw material, produced at its Siheung plant in Gyeonggi Province, to its Indian partner Gland Pharma. Gland Pharma then manufactures the finished product. The product license in China is jointly held by Gland Pharma and its affiliate, Suzhou Erye Pharmaceutical.


JW Pharmaceutical signed an export contract for Ertapenem raw material with Gland Pharma in 2017. Since then, finished products based on this raw material have received product approval and have been marketed in the United States, Canada, and other countries. With this recent product approval in China, the market has now expanded to the Asian region.


Ertapenem is a next-generation carbapenem antibiotic, following penicillins and cephalosporins, and is used to treat a variety of bacterial infections, including skin and soft tissue infections, pneumonia, urinary tract infections, and acute pelvic infections. It is recognized for its broad-spectrum antibacterial activity and excellent efficacy against resistant bacteria, making it effective even in refractory infections. The original drug, INVANZ, was developed by Merck in the United States.


According to global market research firm Grand View Research, the global carbapenem antibiotic market is projected to grow from approximately $3.78 billion in 2023 to $5.24 billion in 2030. The Chinese carbapenem antibiotic market is expected to expand from about $298 million in 2022 to $484 million in 2030.


Since the early 1990s, JW Pharmaceutical has accumulated core technologies and know-how in the field of carbapenem antibiotics. In 2004, the company succeeded in developing the world’s first generic version of Imipenem, and has since achieved independent synthesis of raw materials for Meropenem, Ertapenem, and Doripenem. As a result, JW Pharmaceutical is the only company in Korea with a full portfolio of carbapenem antibiotics. The company plans to further expand exports of carbapenem antibiotic raw materials and finished products through JW Holdings, which oversees its global business.


A JW Pharmaceutical official stated, "This product approval for Ertapenem in China is further evidence of the competitiveness of Korean raw materials in the carbapenem antibiotic sector, which requires advanced synthesis technology. We will continue to strengthen our cooperation with global partners to accelerate entry into next-generation antibiotic markets, including Ertapenem and Doripenem."


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