-JW Sihwa Plant certified by the U.S. Food and Drug Administration for cGMP
-The first U.S. DMF approved of Active Pharmaceutical Ingredient (API) for Penem antibiotics in Korea
-Finished Drug manufactured by Gland Pharma in India; and marketing and distribution in the U.S. by Dr. Reddy’s Laboratories
-Plans to expand market including Canada and expects API business extend to USD 10 million
Successfully completed the entering of ‘Ertapenem injection’, the latest carbabenem antibiotics, by suppling of API which has developed and manufactured by JW Pharmaceuticals for the first time in Korea.
JW Pharmaceutical announced on 9th June that ‘Ertapenem for Injection’ using API made with its own technology had been launched in the U.S.
This is the first time that the finished drug produced from domestic Carbapenem antibiotics is marketed and sold in the U.S., the largest market in the world.
JW Holdings made a supply agreement on Ertapenem API in 2017 with Gland Pharma, India, and JW Pharmaceuticals received cGMP certification on the dedicated facility of Penem antibiotics in Sihwa Plant as well as DMF(Drug Master File) certification on Ertapenem API, accordingly.
Gland Pharma developed the finished drug made with Ertapenem API manufactured by Sihwa plant of JW Pharmaceutical and get an approval from the U.S. FDA in March. Dr. Reddy’s has launched the product in the U.S. market.
Ertapenem, which is drawing attention as the next-generation antibiotic of the Carbapenem following penicillin and cephalosporin, is used for intractable infections such as skin tissue infections, pneumonia, urinary tract infections, and acute pelvic infections based on its extensive antibacterial effect and excellent efficacy on resistant bacteria. ‘Ertapenem for Injection’ is a therapeutic equivalent generic version of INVANZ for injection of Merck & Co.
JW Holdings, which is in charge of the global business of JW Group, has secured a stable export market by supplying Ertapenem API to Gland Pharma from now on. In addition, it is currently preparing to enter the other overseas markets including Canada along with Gland Pharma and is expected to export more than $10 million of Ertapenem API annually.
As entering the biggest and most advanced market, the US, JW Holdings is planning to accelerate its penetration into the global Carbapenem antibiotic market. While JW gets into its stride on advance to the global market for Doripenem which is the latest Carbapenem that succeeded in developing with its own technology independently for the first time in Korea, it is planning to expand the sales of both API and finished drug of Imipeneme and Meropenem, exporting to more than 40 countries including China and Japan.
“The first entry in the US market with domestic API in the field of Carbapenem antibiotics which requires high-level of synthetic technology has raised the status of domestic pharmaceutical company and proved JW’s excellent technology” and “we will continue to strengthen cooperation with global partners in order to accelerate our entry into next-generation Carbapenem markets such as Ertapenem and Doripenem” says Sung-Kwon Han, President and CEO of JW Holdings.
JW Pharmaceutical has secured global competitiveness by accumulating know-how in the field of Carbapenem antibiotics since early 1990. After succeeding in developing the world’s first generic of Imipeneme in 2004, JW has succeeded in synthesizing its own API of Meropenem, Ertapenem and Doripenem, and became the only company having and manufacturing the full portfolio in Korea. JW Pharmaceutical has an overseas export base with an exclusive plant for API synthesis in Sihwa and a dedicated facility for the finished drug in Dangjin complex.
Meanwhile, according to global IQVIA data, the global Carbapenem antibiotic market is approximately over $2 billion in 2020, of which Ertapenem has the market size of $401 million. In the US market, the total sales of Carbapenem antibiotics are $344 million and the ‘Ertapenem for Injection’ is approximately $213 million.
About Gland Pharma Limited(BSE: 543245, NSE: GLAND) :
Gland Pharma was established in 1978 in Hyderabad, has grown over the years from a contract manufacturer of small volume liquid parenteral products, to become one of the largest and fastest growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India and other markets. It operates primarily under a business to business (B2B) model and have an excellent track record in the development, manufacturing and marketing of complex injectable. It has a wide range of injectable, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology and ophthalmic solutions and also enjoys the distinction of having pioneered Heparin technology in India. For more information, log on to: www.glandpharma.com
About Dr. Reddy’s(BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) :
Dr. Reddy’s Laboratories Ltd. is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Its major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy’s operates in markets across the globe. Its major markets include – USA, India, Russia & CIS countries, and Europe. For more information, log on to: www.drreddys.com.