Address:2F, No. 368, Sec, 1,
Fusing S.Road, Taipei
OP Official Website
|Focus on 505(B)(2)R&D and Clinical Trials of New Drug and Meet PIC/S and US FDA standards|
Established in 2008,OrientPHARMA CO., Ltd.(OP) is one of critical subsidiary of Orient EuroPharma Co., Ltd.. The primary emphasis is on R&D, clinical trials and manufacturing of new drugs. 2013, OP was ranked as one of the 17 indicators business by IBMI(Institute for Biotechnology and medicine industry.)
OrientPHARMA Co., Ltd. collaborated with multinational pharmaceutical companies to develop new drugs which meet the U.S. FDA standards, including New dosage form, New formulation,New indication, and new combination. Especially in disease fields with unmet medical needs.
Futhermore, OrientPHARMA Co. submitted Paragraph Ⅳ of ANDA to challenge the patents of an anti-hyperlipidemia product, in 2014, U.S. FDA has acceptd our Paragraph Ⅳ of challenge. Besides, muscle relaxant drug Carisoprodol talbets get the license from US FDA. 2015, OP received another generic license for treating diabetes, Miglitol tablet (25, 50, 100mg)
OrientPHARMA Co., Ltd owns three unique and innovative drug development technology plateforms, Multi-Phasic Release Technology(MPRT), Multi-Day Transdermal Drug Delivery (MTDD), and Multi-Layered Pulsatile Release Technology(MLPT), to establish self-owned R&D competency. 2014 OP authorized our trans-dermal patches technology to BeiJing TIDE Pharmaseutical .com., LTD, jointly develop dementia drugs, and expand the global market.
The Plant was located in Central Taiwan Science Park of Huwei Township, Yunlin County. OP adopts the worldwide famous manufacturing equipment such as Glatt, SERVOLIFT, FETTE, to maintain the quality and stability of products and to fulfill the criteria of international partners and clients. OP has introduced from overseas pharmaceutical companies patent-protected technology to produce new products in Taiwan, and applied for product certifications in Japan, US and the European Union to enter overseas markets.
OrientPHARMA CO., Ltd. has obtained the PIC/S GMP certificate from Taiwan FDA passed plant inspection by U.S FDA, and received ”Accreditation Certification of Foreign Drug Manufacturer" from Japan MHLW.
|2008||Establishment of Orient PHARMA CO., Ltd.|
|2010||Completion of the manufacturing plant at the Huwei Section of the Taichung Technology Park.|
|2011||Taiwan FDA PIC/S GMP certificate.|
1.Obtained ”Accreditation Certification of Foreign Drug Manufacturer" from Japan MHLW.
1.Passed the plant inspection by U.S. FDA
1.U.S. FDA has accepted our Paragraph Ⅳ challenge to Pitavastatin
1. Generic drug 「Miglitol」has been approved by US FDA
1. Muscle relaxant Carisoprodol and anti-diabetic agent Miglitol have been launched in US.