API Manufacturing facilities
The API manufacturing division is engaging in high-quality synthetic API production using the state of the art facilities in strict compliance with GMP regulations. The API plant consists of 3 separate buildings where are the Cephalosporin plant(API), cytotoxic anticancer plant(API&FDF), and General API building(API & Intermediates) complying with international GMP regulation.
In particular, it has the best production infrastructure such as Building Management System (BMS) and an automated warehouse to create an optimal pharmaceutical production environment. These systems contribute to Jeil Pharm to be one of the global pharmaceutical companies offering innovative healthcare solution to the market
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Dedicated manufacturing buildings
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| Cephalosporins : SUS, G/L and Hastelloy reactor, Freeze dryer . STS Reactor |
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| Cytotoxic Anti-Cancer : G/L reactor |
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| General API : High Pressure SUS Reactor, G/L reactor |
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History
| 2019.7 |
Registered Master File of Cinacalcet in Japan (PMDA) |
| 2017.10 |
Registered Master File of Meropenem in Japan (PMDA) |
| 2017.04 |
Received CEP/COS for Cefpodoxime Proxetile(EDQM, Europe) |
| 2012.07 |
Enlargement of Sterile Crystallization capacity for Carbapenems |
| 2012.03 |
Constructed dedicated facility for Cephalosporin and Cytotoxic anticancer |
| 2011.10 |
Enlargement of Sterile Lyophilization capacity for Cephalosporin |
| 2011.08 |
Launched Meropenem Inj. in Korea/td>
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| 2010.10 |
Started supplying Carbapenem APIs to its originator in Japan |
| 2010.02 |
Succeeded in commercial manufacturing Sterile Flomoxef sodium |
| 2009.05 |
Obtained GMP approval for sterile APIs by PMDA in Japan |
| 2008.07 |
Received EDQM GMP audit for sterile APIs |
| 2007.02 |
Started exporting Imipenem/Cilastatin (FDF / APIs) |
| 2006.01 |
Started producing Panipenem/Betamipron (Powder formulation) |
| 2005.01 |
Started producing Cilapenem (Imipenem/Cilastatin) (Powder formulation) |
| 2004.11 |
Started producing Cefditoren Pivoxil (Oral antibiotic) |
| 2003.03 |
Started exporting Injection in vial forms |
| 2003.01 |
Started exporting Cefditore Pivoxil(API) |
| 2002.07 |
Constructed a plant for synthesis of sterile and antibiotic APIs |
| 2001.06 |
Started exporting Piperacillin Acid to Toyama Chemical in Japan |
| 2001.02 |
Started producing Epinastine HCl |
| 2000.03 |
Started producing Cefteram Pivoxil |
| 1999.05 |
Obtained BGMP for all product (general, special, sterile) |
| 1998.04 |
Started OEM production for the sterile lyophilized product (Vancomycin) |
| 1998.02 |
Started exporting Sulbenicillin Sodium to Takeda Pharm in Japan |
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Major Products
| Cephalosporin
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Cefditoren Pivoxil/ Cefteram Pivoxil / Cefcapene Pivoxil/ Flomoxef soduim/ Latamoxef soduim |
| Cytotoxic
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Irinotecan HCl/ Pemetrexed Sodium
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| General API
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Epinastine HCl/ Rosuvastatin Calcium/ Entecavir monohydrate/ Sarpogrelate HCl/ Clopidogrel Bisulfate/ Adefovir dipivoxil/ Bosentan hydrate
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