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Bio B2B 〉Orient Pharma Co., Ltd.

Orient Pharma Co., Ltd.

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 Orient Pharma (OP) was established on Feb 1, 2008. It is focusing on the development and manufactureing of 505(b)(2) new drugs. There are more than 170 employee and 35% are dedicated to R&D.  70% of the employee own master or PhD degrees. Located in Yunlin county in the central of Taiwan, the Yunlin plant obtained the approval for PIC/S GMP from the Taiwan FDA in 2011. In addition, it received “Accreditation Certificate of Foreign Drug Manufacturer” from Japan Ministry of Health, Laboar, and Welfare (MHLW) in 2012. Furthermore, the Yunlin plant passed the cGMP site inspection by US FDA in 2013.With annual production capacity of more than 850 million units, Orient Pharma ‘s Oral dosage form (ODF) facility is capable to meet demand from any international market . Orient Pharma has established strong partnership with global companies like Teva, SUN Pharma, Jubilant, Supernus, Reckitt Benckiser, Beijing Tide, etc. Combined with the comprehensive sales force and network across Pacific Asia of mother company Orient EuroPharma (OEP), Orient Pharma is capable to collaborate with global partners from R&D, clinical development, manufacturing,  to commercialization.

R & D:
  • Utilize Multiple-Phasic Release Technology (MPRT) and Multi-day Transdermal Drug Delivery (MTDD) to develop new products based on medical needs, market potential, and product characteristics.
  • Product development complies with US FDA QbD (Quality by design).
  • Devote in developing patents and  continuously apply for patent in Japan, Europe and US to increase the product value.

Clinical Development:
  • With the well-experienced Clinical Research Team (>20 members), Orient Pharma can conduct multi-national & multi-centered clinical trials.
  • Certificated of “Medical Research Service Company” by Ministry of Economic Affairs, Taiwan.
  • Succesfully passed the GCP inspection by the health authorities in Taiwan and Singapore.

Manufacturing:
  • Capable of R&D, investigational drugs and commercial production with facilities of well-known brands, like Glatt, Servolift, and Fette, to ensure reproducibility and stability.
  • Utilize API with DMF. Excepients and packaging materials pass strict inspection and examination.

Regulation:
  • Registration Team is experienced in US FDA and Taiwan FDA pre-IND meeting, IND, and NDA.

Commercialization:
  • The OEP group has over 400 dedicated sales and marketers in Asia Pacific to professionally fulfill the local needs.
     

Please visit http://www.oppharma.com/index.php/eng/index for more information.
  • Calvin Tsai, General Manager

    Calvin Tsai, General Manager

    1.Assistant Marketing Manager, Pierre Fabre, France
    2.Accounting, University of California, Riverside, USA
    3.Certified Public Accountant in USA
  • Michael Hsiao, VP, Global Sales

    Michael Hsiao, VP, Global Sales

    1. Chief Operation Officer, Carlsbad Technology Inc., USA
    2. Master, Pharmaceutical Marketing, Long Island University, USA
  • CT Chang, Director, RA & Clincal Dev.

    CT Chang, Director, RA & Clincal Dev.

    1. Manager, RD/Drug Development, Genovate Biotechnology, Co., Ltd.
    2. PhD, Chemistry, University of Pittsburgh, USA
  • David Wong, Director, R&D

    David Wong, Director, R&D

    1.Vice President, Magnifica Inc., USA
    2.Senior Director, Product Dev.& Manuf., Biokey Inc., USA
    3.PhD, The University of Texas at Austin, USA
  • Jill Wang, Director, QA

    Jill Wang, Director, QA

    1. QA/QC Manager, Nang Kuang Pharmaceutical Co., Ltd
    2. Wyeth BioPharma, USA
    3. Master, Pennsylvania State University, USA
  • PC Yang, Director, Plant

    PC Yang, Director, Plant

    1. Bristol-Myers Squibb Taiwan
    2. Genovate Biotechnical Taiwan
    3. Mentholatum(China) Pharmaceuticals Co., Ltd
 Orient Pharma (OP) was established on Feb 1, 2008. It is focusing on the development and manufactureing of 505(b)(2) new drugs. There are more than 170 employee and 35% are dedicated to R&D.  70% of the employee own master or PhD degrees. Located in Yunlin county in the central of Taiwan, the Yunlin plant obtained the approval for PIC/S GMP from the Taiwan FDA in 2011. In addition, it received “Accreditation Certificate of Foreign Drug Manufacturer” from Japan Ministry of Health, Laboar, and Welfare (MHLW) in 2012. Furthermore, the Yunlin plant passed the cGMP site inspection by US FDA in 2013.With annual production capacity of more than 850 million units, Orient Pharma ‘s Oral dosage form (ODF) facility is capable to meet demand from any international market . Orient Pharma has established strong partnership with global companies like Teva, SUN Pharma, Jubilant, Supernus, Reckitt Benckiser, Beijing Tide, etc. Combined with the comprehensive sales force and network across Pacific Asia of mother company Orient EuroPharma (OEP), Orient Pharma is capable to collaborate with global partners from R&D, clinical development, manufacturing,  to commercialization.

R & D:
  • Utilize Multiple-Phasic Release Technology (MPRT) and Multi-day Transdermal Drug Delivery (MTDD) to develop new products based on medical needs, market potential, and product characteristics.
  • Product development complies with US FDA QbD (Quality by design).
  • Devote in developing patents and  continuously apply for patent in Japan, Europe and US to increase the product value.

Clinical Development:
  • With the well-experienced Clinical Research Team (>20 members), Orient Pharma can conduct multi-national & multi-centered clinical trials.
  • Certificated of “Medical Research Service Company” by Ministry of Economic Affairs, Taiwan.
  • Succesfully passed the GCP inspection by the health authorities in Taiwan and Singapore.

Manufacturing:
  • Capable of R&D, investigational drugs and commercial production with facilities of well-known brands, like Glatt, Servolift, and Fette, to ensure reproducibility and stability.
  • Utilize API with DMF. Excepients and packaging materials pass strict inspection and examination.

Regulation:
  • Registration Team is experienced in US FDA and Taiwan FDA pre-IND meeting, IND, and NDA.

Commercialization:
  • The OEP group has over 400 dedicated sales and marketers in Asia Pacific to professionally fulfill the local needs.
     

Please visit http://www.oppharma.com/index.php/eng/index for more information.
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