Alchem offers Phytochemical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.
01 1Alchem International Private Ltd
01 1HYOSCINE EP (SCOPOLAMINE)
01 1India
01 1Active
01 1Complete
Alchem offers Phytochemical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.
GDUFA
DMF Review : Complete
Rev. Date : 2017-09-14
Pay. Date : 2017-06-02
DMF Number : 30687
Submission : 2016-07-06
Status : Active
Type : II
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Alchem International Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
They are recognized for Alchem offers Phytochemical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.
One of their notable products is HYOSCINE EP (SCOPOLAMINE), with a corresponding US DMF Number 30687.
Remarkably, this DMF maintains an Active status since its submission on July 06, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 14, 2017, and payment made on June 02, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
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