2024
Aug.
API-7 line inspected and approved by Taiwan FDA
2024
Jun.
General GMP inspected and approved by Taiwan FDA
2024
Mar.
Cytotoxic Liquid Injectable Line inspected and approved by TFDA
2023
Jul.
Oral solution line, API-6 line inspected and approved by US FDA
2023
Feb.
API- 5 line inspected and approved by Taiwan FDA
2022
Nov.
NFT solution line inspected and approved by Taiwan FDA
2022
Sep.
AMA-S, CPA-I inspected and approved by US FDA
2022
Jun.
Packaging Line inspected and approved by Taiwan FDA
2021
Jun.
API (API- 4) line inspected and approved by Taiwan FDA
2021
Apr.
Tablet in capsule line inspected and approved by Taiwan FDA
2021
Mar.
5th US ANDA Approval (Injection)
2020
Oct.
API (API-3) line inspected and approved by Taiwan FDA
2019
Oct.
US FDA inspection with zero-483
2019
Mar.~Sep.
API (API-1, API-2) line inspected and approved by Taiwan FDA
2019
Jan.
First oral line inspected and approved by Taiwan FDA
2018
May~Dec.
2nd~4th US ANDAs Approval (Capsule, Tablet, Injection)
2018
Mar.
Manufacturing facility established
2017
Sep.
1st US ANDA Approval (Ointment)
2014
Sep.
Sunny established
Sunny Pharmtech was established in 2014 integrating API and drug product research and development capabilities for oral and injectable dosage forms. First ANDA approval received in 2017.
Several products were later launched in US market demonstrating Sunny’s vision to “Develop and Manufacture locally for global market.”
Sunny strives to become R&D center for development of high-value products, by integrating cutting-edge technologies, equipment and talents to provide solution for process development, scale-up manufacturing, ANDA submission for competing in global markets.
In addition, Sunny also provides CDMO/CMO services for development of injectable, control-released formulations, and special dosage forms with our in-house expertise for NCEs, Generic and 505(b)(2) products.
