OrientPHARMA CO., Ltd.(OP) is the subsidiary company of Orient EuroPharma Co., Ltd., established in 2008. The primary strength is on R&D, clinical trials and manufacturing of new drugs. The plant in Yunlin is a whole new constructed plant which had been certified by Taiwan PIC/S GMP, Japan “Accreditation Certificate of Foreign Drug Manufacturer” and cGMP inspection by US FDA.
OP utilizes its technology platform of Multi-Phasic Release Technology (MPRT), focusing on developing 505 (B) (2) new drugs including new dosage forms, new formulations, new indications and new compounds. OP develops new drugs in line with trends and unmet medical needs, and cooperates with international R&D companies to accelerate the development of new drugs. Its research and development results have obtained multi-national patents. By 2022, it has obtained five US ANDA and 1 TW 505(b)(2) drug certificates . In addition, there are 4 new 505(b)(2) combo products under development. Holding the vision of being a “global professional specialty pharma”, OP continues to use patented technology to develop 505 (b) (2) new drugs and niche generic drugs, and expand production capacity to grow up the international market.
|2008||Orient PHARMA Co., Ltd. Established in Feb, 2008.|
|2011||OrientPHARMA Received the Domestic PICS GMP Certification|
|2012||Listed in Taipei Exchange, stock code: 4166|
|2014||OrientPHARMA Signs an Agreement with Actavis for the Introduction of Generic Antihyperlipidemic, Pitavastatin, to the U.S. Market|
|2014||OP’S Carisoprodol Tablets USP 350mg, has officially received the license from US FDA|
|2015||OP’s Milglitol license was approved by US FDA.|
|2017||The Paragraph IV ANDA application of PITAVASTATIN has approved by U.S. FDA.|
|2017||Methydur Sustained Release Capsules for treating ADHD showed significant benefits in Phase III trial.|
|2019||OP obtained USFDA approval of generic drug for diabetes, Glyburide Tablets USP (1.25 mg, 2.5 mg, 5 mg)|
|2019||OP obtained USFDA approval of generic drug for infection, Vancomycin Hydrochloride Capsules USP (125 mg and 250 mg)|
|2019||Orient PHARMA Co., Ltd (Methydur Sustained Release Capsules) awarded the Innovation of the Year of 2019 Taiwan Bio-Industry Organization Awards|
|2020||Methydur Sustained Release Capsules (Methydur), is the first marketed 505(b)(2) new drug internationally with clinical value in Taiwan, obtained a premium health insurance reimbursement price|
|2021||1PC111 product completed clinical Phase III study in Taiwan, Australia and New Zealand and Taiwan 505(b)(2) new drug registration.|