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About Hanmi

History

History
Date Content
2016-06
Environmental Management System(ISO 14001) Reapproved
2016-05
Selected and awarded as the best company by Gyeonggi District Employment and Labor Office
2016-05
Safety & Health Management System(K-OHSMS 18001/OHSAS 18001) Approved
2015-12
Awarded for Chemical Accident Prevention and Response by Environment Minister
2015-04
Re-inspected & Re-approved by US FDA
2015-01
Inspected & Approved by Japanese PMDA
2014-08
Re-inspected & Re-approved by Germany BGV
2014-05
Re-inspected & Re-approved by Korea MFDS
2013-08
Inspected & Approved by Mexico COFEPRIS
2013-04
Inspected & approved by US FDA (Esomeprazole Sr)
2013-04
Re-acquired the CGMP compliance certification from US FDA (Esomeprazole Sr)
2011-10
Re-acquired EU GMP compliance certification after GMP inspection by BGV (Germany)
2011-10
Inspected by German BGV and Granted EU GMP Certificate in Apr. 2012
2011-07
ISO 9001 & 14001 Certificate Granted
2011-07
Acquired ISO 9001 & 14001 Certifications
2011-05
CEP Granted to Sterile Ceftazidime for Injection
2011-03
Inspected & approved by US FDA (Esomeprazole Sr)
2011-03
Acquired the compliance certification after pre-approval inspection by US FDA (Esomeprazole Sr)
2010-10
Re-acquired GMP compliance certification after GMP inspection by PMDA (Japan)
2010-10
Inspected & approved by Japanese PMDA (Pioglitazone HCI)
2010-06
Designated as a “Company with Excellent Labor-Management Culture” (Ministry of Employment and Labor)
2009-07
Re-acquired GMP compliance certification after GMP inspection by TGA (Australia)
2009-07
Inspected by Australian TGA and Granted GMP Certificate (Esomeprazole Sr/Sibutramine Mesilate)
2009-06
Designated as a “Company with Excellent Working Environment” (Gyeonggi-do)
2009-03
Re-acquired the GMP compliance certification from MHRA (UK)
2008-12
Inspected by UK MHRA and Granted EU GMP Certificate
2008-11
Awarded the 50 Million Dollar Export Tower on the 45th Trade Day
2008-06
Acquired the EU GMP Certification from BSG (Germany) for the general plant (Production Building C)
2008-01
Korea’s first company to be approved by FDA to market ceftriaxone sodium in the US
2007-11
Inspected by German BSG and Granted EU GMP Certificate in Jun. 2008
2007-06
Completed the Construction of Plant C (General APIs)
2007-05
Completed the construction of the general plant (Production Building C)
2007-03
Registered a patent in Japan (for the method of manufacturing cephalosporin-based antibiotics using new thiazole compound)
2006-12
Inspected by UK MHRA and Granted EU GMP Certificate in Nov.2006
2006-11
Re-acquired the GMP compliance certification from MHRA (UK)
2006-04
Acquired CGMP compliance certification after GMP inspection by the US FDA (Sterile Ceftriaxone Sodium, FMD 145 letter)
2006-04
Inspected by US FDA and ANDA Approved in Jan.2008 (Sterile Ceftriaxone Sodium)
2004-11
Awarded the 30 Million Dollar Export Tower on the 41st Trade Day
2003-09
Acquired CEP certifications for Cefixime and Ceftazidime
2003-09
CEP Granted to Sterile Ceftazidime & Cefixime
2003-07
Authorized as a manufacturer of pharmaceutical products, etc. for animals (National Veterinary Research and Quarantine Service)
2003-07
Registered a patent in Korea (for the method of manufacturing cephalosporin-based antibiotics using new thiazole compound)
2003-06
Inspected by German BUG in Hamburg and EU GMP approved
2002-12
Selected as “World-Class Product” (Ceftriaxone Sodium)
2002-05
Acquired US Patent (for the method of manufacturing cephalosporin-based antibiotics using new thiazole compound)
2001-08
Acquired US Patent for intermediate material (new thiazole compound and the manufacturing method thereof)
2000-09
Awarded the Venture Company Prize (Administrator of Small & Medium Business)
2000-09
Acquired the GMP compliance certification from MCA (UK) for the injectable agent manufacturing facilities
2000-09
Inspected by UK MCA (former UK MHRA) and EU GMP approved
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Add.
59, Gyeongje-ro, Siheung-si, Gyeonggi-do, Korea
Tel.
+82-031-499-2541
Fax.
+82-031-499-2540

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