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Established in Shenzhen, China
Techdow's enoxaparin sodium injection (Prolongin庐) became the first generic enoxaparin approved by China's National Medical Products Administration (NMPA, formerly CFDA)
The enoxaparin sodium API production line passed the GMP inspections in China for the first time
The enoxaparin sodium API production line passed the inspection by the U.S. Food and Drug Administration (FDA) for the first time
Techdow's enoxaparin sodium API production line passed the inspection by Poland's Main Pharmaceutical Inspectorate (GIF) for the first time
Techdow's enoxaparin sodium injection packaging line #1 passed the inspection by Poland's GIF for the first time
Techdow's enoxaparin sodium injection syringe prefilling line #1 and vial production line passed the inspection by Poland's GIF for the first time
Techdow's enoxaparin sodium prefilled syringe production line passed the GMP inspection in China for the first time
Techdow's enoxaparin sodium injection (Inhixa/Neoparin) approved in the EU as the first enoxaparin biosimilar product in the region and the company began to build local sales teams for the 5 major European markets (Poland, Italy, United Kingdom, Germany, Spain)
Acquired by Shenzhen Hepalink Pharmaceutical Group Co., Ltd., thus completed Hepalink's vertical integration of the entire heparin industrial chain with end-to-end coverage from APIs to heparin injections
Techdow's enoxaparin sodium PFS filling line #1 passed the inspection by the U.S. FDA for the first time
Techdow's enoxaparin sodium vial bottling line passed the inspection by the U.S. FDA for the first time
Techdow's enoxaparin sodium PFS filling line #2 and packaging line #3 passed the inspection by Poland's GIF for the first time
All SKUs of enoxaparin sodium injection (Prolongin庐) marketed in China passed the Bioavailability Equivalence Evaluation of the Quality and Efficacy of Biosimilar, and became the first product that passed the evaluation in China at the time
Established Techdow USA and began building a local sales team in the U.S.
Techdow's enoxaparin sodium PFS filling line #2 passed the inspection by Poland's GIF for the first time
Officially began selling heparin sodium injections in the U.S.
The company鈥檚 enoxaparin sodium injection product (Enoxaparin Sodium Injection, USP) was approved by the U.S. FDA and subsequently launched in the U.S. market
Techdow's enoxaparin sodium injection (Prolongin庐) became the first enoxaparin product selected by the 8th Centralized National Procurement in China