Milestone |
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ĄDStar-up of the company with dedicated focus on Prostaglandin(PG) APls. |
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cGMP compliance by governmental inspections. |
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Start-up of Wulin Plant for dedicated commercial production of Latanoprost. |
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Filing of process patents that are advantageous for synthesizing PGF2Ł\
compounds with major patent offices worldwide.
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Filing of first US DMF of the company for Latanoprost. |
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First successful US FDA Inspection. |
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Acquisition of Youth plant to accommodate growing business and employees. |
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Relocating Headquarters and Quality Unit to Youth plant. |
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Acquisition and construction of ChungLi plant for production of intermediates
and starting materials.
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Complete construction of 3 plants, all located in Taoyuan, Taiwan, comprising
of more than 6 independent production lines, dedicated for manufacturing of
different prostaglandin APIs, and one intermediate building for producing
intermediates in tons scale.
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The company owns 3 active DMFs with US FDA and has developed filing
experiences in Japan, Canada, China, Australia, New Zealand, and EU countries.Ą@
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4 patents for proprietary synthesis of Prostaglandin F2Ł\-related compounds
such as Latanoprost, Bimatoprost, and Travoprost have been granted approval
in US.
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Second successful US FDA Inspection for Latanoprost and Bimatoprost. |
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Acquisition of Yangmei plant for expansion of state-of-the-art production
workshops.
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Certified as a supplier of reference standards for US Pharmacopeia. |
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Successful inspection by COFEPRIS. |
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Third successful US FDA Inspection. Three more US DMFs and EU DMF are
filed.
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The patent of processes and intermediates for the preparations of isomer free
prostaglandins has been granted approval in US.
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Complete construction of Yangmei plant, capable of providing 10 more
dedicated and independent production workshops for increasing market
demands.
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Successful inspection by PMDA. |
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Filed more DMFs in US, EU, Canada, Japan...etc. |
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