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Alps Pharmaceutical Ind Co Ltd, based in Japan, is a pharmaceutical company that stands out with its certifications from FDA and WHO-GMP.
One of their notable products is PROTAMINE SULFATE, with a corresponding US DMF Number 20538.
Remarkably, this DMF maintains an Active status since its submission on May 11, 2007, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 18, 2018, and payment made on September 27, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II