Contact
Tel:+886 2 2325 7621
Address:2F, No. 368, Sec, 1,
Fusing S.Road, Taipei
E-mail:  bd@oppharma.com
OP Official Website
About OP
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 drug s which meet the U.S. FDA standards, including New dosage form, New formulation,New indication, and new combination. Especially in CNS field, including anti-psychotics, drugs for treating Alzheimer’s disease, psychostimulants, and drugs for treating Parkinson’s disease.

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 5 technologies patients as multi-stages controlled release technology, trans-dermal patches, oral disintegrating tablets, sustained release technology and microgranules. 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.And passed plant inspection by U.S FDA.


Company History
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.
2012

1.Obtained ”Accreditation Certification of Foreign Drug Manufacturer" from Japan MHLW.
2.Listed to emerging stock market in Taiwan.

2013

1.Passed the plant inspection by U.S. FDA
2.Awarded with the pharmaceutical Good Distribution Practice (GDP) certification from Taiwan FDA

2014

1.U.S. FDA has accepted our Paragraph Ⅳ challenge to Pitavastatin
2. An agresment of coopetatoin has been signed with Actavis in the hopes to together enter into the U.S. generic drug market
3. Generic drug 「Carisoprodol」has been approved by US FDA
4. Signed agreement with Beijing Tide Pharma for Anti-Dementia Patch technology transfer and product supply

2015

1. Generic drug 「Miglitol」has been approved by US FDA