Sunny Pharmtech hits another FDA milestone! AMA-S has received FDA approval.

撰文GlobalBio & Investment
日期2023-12-31
Sunny Pharmtech
Sunny Pharmtech hits another FDA milestone! 

Congratulations to Sunny Pharmtech Inc (6676. TWO) on their new success! Their CPA-I smoothly shipped to the U.S. earlier this month, and now the AMA-S (Aminocaproic Acid Solution) has received FDA approval by month-end.

AMA-S, developed in-house, shares the same active ingredient as their marketed AMA-T, differing only in dosage form. Sunny Pharmtech independently develops and manufactures both drugs, from the active pharmaceutical ingredient (API) to the formulation. Particularly beneficial for patients unable to swallow, AMA-S offers enhanced drug compliance.

In December, the FDA green-lighted AMA-S, marking Sunny Pharmtech's second FDA-approved generic drug in 2023. With 8 FDA approvals, Sunny Pharmtech has several products undergoing approvals in the U.S., China, and Taiwan.

Read more: https://news.gbimonthly.com/tw/article/show.php?num=63975
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