2018

Through GMP inspection by ANVISA (Brazil) for Carbamazepine (Waisha Site)

Through GMP inspection by COFEPRIS (Mexico) for Tenofovir Disoproxil Succinate and Abacavir (Waisha Site)

Through GMP inspection by US FDA for Sulfadimethoxine, Sulfadimethoxine Sodium, Imatinib Mesylate(Waisha Site)

2017

Through GMP inspection by CFDA for Gliclazide (Waisha Site)

Through GMP inspection by PMDA (Japan) for Sulfasalazine(Waisha Site)  and Meropenem (Raybow Site)

2016 

Company passed US FDA inspection (focus on Sulfadimethoxine, Sulfadimethoxine Sodium, Carbamazepine, C8 and DKTO) 

Through GMP inspection by AIFA (Italy) for Ketoprofen and Gliclazide

Through GMP inspection by Mexico for Sulfasalazine 

Through GMP inspection by ANVISA (Brazil) for Carbamazepine (Raybow Pharma) 

Through GMP inspection (2010) by CFDA for Carbamazepine and Ketoprofen (Raybow Pharma)

2015

Through GMP inspection (2010) by CFDA for Sulfasalazine

Through GMP inspection by Mexico for Bezafibrate and Ketoprofen 

Through DIRECTIVE 2011/62/EU inspection by CFDA and obtain the Written Confirmation 

2014 

Through GMP inspection by PMDA (Japan) for Ketoprofen and Meropenem

Company passed US FDA inspection (focus on series of NLDK CMO product) 

Through GMP inspection (2010) by CFDA for Gliclazide 

Through EDQM inspection for Carbamazepine 

Through GMP inspection by Mexico and ANVISA (Brazil) 

2013 

GMP inspection by Hungary and obtain the Certificates 

Through GMP inspection by Mexico for Bezafibrate, Ketoprofen and Oxcarbazepine 

2012

Through GMP inspection (2010) by CFDA for Bezafibrate

Through again GMP inspection by ANVISA (Brazil) for Carbamazepine

2011 

Company passed US FDA inspection (focus on Sulfadimethoxine and Sulfadimethoxine Sodium) 

Through GMP inspection by ANVISA (Brazil) for Carbamazepine

Through GMP inspection by AIFA (Italy) for Ketoprofen, Ketoprofen Lysinate and Gliclazide

2010 

Through again the GMP inspection by TGA (Australia) 

Through Veterinary Drug GMP inspection by Ministry of Agriculture for Amprolium 

2009

EDQM COS for Venlafaxine Hydrochloride

CFDA GMP Certificate for Gliclazide

Through GMP inspection by KFDA (Korea) 

2008 

GMP inspection by TGA (Australia) 

2007

GMP inspection by AIFA (Italy), EDQM (Council of Europe) and FDA 

2006

EDQM COS for Carbamazepine, Gliclazide

ISO 9001 Certification 

2005 

EDQM COS for Sulfasalazine, Albendazole

CFDA GMP Certificate for Carbamazepine, Norfloxacin, Ketoprofen and Sulfasalazine

2004 

CFDA GMP Certificate for Gliclazide, Gemfibrozil and Sulfasalazine 

EDQM COS for Ketoprofen 

Company passed US FDA inspection (focus on Amprolium) 

2003

ISO 9001 Certification 

2002 

CFDA GMP Certificate for Ketoprofen and Albendazole 

2000

ISO 9002 Certification

CFDA GMP Certificate for Carbamazepine and Norfloxacin