KEY PRODUCTS
Alchem offers Botanical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.
01 1Alchem International Private Ltd
01 1METHSCOPOLAMINE BROMIDE USP
01 1India
01 1Active
01 1Complete
Alchem offers Botanical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.
GDUFA
DMF Review : Complete
Rev. Date : 2015-11-20
Pay. Date : 2015-09-28
DMF Number : 29805
Submission : 2015-09-24
Status : Active
Type : II
20
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 Botanical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.
One of their notable products is METHSCOPOLAMINE BROMIDE USP, with a corresponding US DMF Number 29805.
Remarkably, this DMF maintains an Active status since its submission on September 24, 2015, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 20, 2015, and payment made on September 28, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
