Humanwell pharmaceutical vitamin D2 is approved to be listed in the United States!

Recently, puracap pharmaceutical LLC, a subsidiary of humanwell pharmaceutical Holding Co., Ltd (hereinafter referred to as "American puke" for short, humanwell pharmaceutical holds 72% of its equity), received the approval number of ergocalciferol soft capsule from FDA, and obtained the production and sales qualification of the drug in the United States The details are as follows: drug name: ergocalciferol capsules USP (ergocalciferol soft capsule) application matters: anda (brief application for new drugs in the United States, i.e application for generic drugs in the United States) Anda's FDA approval means that the applicant can produce and sell the product in the U.S market.) Anda approval No.: 204276 dosage form: soft capsule specification: 1.25mg (50000 IU vitamin D) drug type: according to the prescription drug announcement, ergocalcitol is the chemical name of vitamin D2, and ergocalcitol soft capsule is used to treat hypoparathyroidism, refractory rickets (or anti vitamin D rickets) and familial hypophosphatemia In 2012, Proctor applied for anda of ergotalcitol soft capsule, with a total R & D investment of about US $1 million According to IMS data statistics, the sales volume of ergotalcitol soft capsules in the U.S market in 2017 is about 17 million US dollars, and the main manufacturers include strides Pharma, sun Pharma, etc According to the data statistics of minenet, in 2017, the sales volume of all vitamin D2 dosage forms in the three terminal public hospitals of cities, counties and towns in China was about 170 million yuan The main manufacturers include Jiangxi Gannan Haixin Pharmaceutical Co., Ltd., Hebei Kaiwei Pharmaceutical Co., Ltd and China Resources Shuanghe Pharmaceutical Co., Ltd The full text of the announcement is as follows: