Orient PHARMA Co., Ltd.


President: Peter Tsai
CEO: Calvin Tsai
Founded in: 1 Feb., 2008
Tel: 886-5-631-1331
Fax: 886-5-636-3331 
Address: Central Taiwan Science Park, No. 8, Kehu 1st Road, Huwei Townhsip, Yunlin County 63247, Taiwan
Website: http://www.oppharma.com/


 

About OP:

Focus on 505 (B) (2) R&D and Clinical Trials of New Drug and Meet PIC/S and US FDA standards 

OrientPHARMA CO., Ltd.(OP) is the subsidiary company of Orient EuroPharma Co., Ltd., established in 2008. The primary emphasis is on R&D, clinical trials and manufacturing of new drugs. It is the first newly constructed pharmaceutical plant in Taiwan which complies with PIC/S GMP, European GMP, and US FDA 21CFR international standards. In 2011, OrientPHARMA CO., Ltd. obtained the PIC/S GMP certificate from Taiwan FDA. In 2012, the company was also approved of the "Accreditation Certification of Foreign Drug Manufacturer" in Japan. In 2013, OrientPHARMA CO., Ltd. passed plant inspection by U.S FDA.

OrientPHARMA CO., Ltd. 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. Also, the OrientPHARMA CO., Ltd. imported new patented manufacturing techniques from other foreign pharmaceutical companies to produce new drugs, and applies for product licenses in Japan, United States, and Europe to enter the global market.

Multiple R&D Technologies and Patents 

OrientPHARMA CO., Ltd. Owns 5 technologies patients as multi-stages controlled release technology, trans-dermal patches, oral disintegrating tablets, sustained release technology, micro granules It aims to develop new drugs which meet the U.S. FDA standards, including new dosage form, new formulation, new indication, and new combination.

In addition, Orient PHARMA CO., Ltd. also collaborated with European and American companies for R&D of new drugs, which could greatly speed up the process and introduce new drugs at a faster pace. The phase Ⅱa clinical trial of the drug for sialorrhea developed by OrientPHARMA CO., Ltd. was completed, and the result was published in the "17th International Annual Parkinson and Motor Dysfunction Forum" in Sydney, Australia, in June 2013. Furthermore, the drug for treating diabetes applied to US FDA in 2011 could become the first generic in the US. In 2013, OrientPHARMA CO. submitted Paragraph IV of ANDA to challenge the patents of an anti-hyperlipidemia product, in 2014, U.S. FDA has accepted our Paragraph IV of challenge. Beside, muscle relaxant drug Carisoprodol tablets get the license from US FDA. OrientPHARMA CO., Ltd. would also apply for drug patents to protect company assets and increase product value.

 

R&D Pipeline in OP

Clinical Trial No.

Indication

Strengths

Stage

OP-2PN012-301

Attention-Deficit Hyperactivity Disorder(ADHD)

Enhance drug efficacy and improve patients’ drug adherence

Phase III

OP-014-201

Sialorrhoea in patients with Parkinson’s disease

Dual mechanism

Phase II

N/A

Tuberculosis

New formulations

Phase I

N/A

Triple-negative breast cancer(TNBC)

New mechanism

Preclinical Testing

N/A

Badder cancer

New mechanism

Preclinical Testing