KEY PRODUCTS
Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.
01 1Lupin Manufacturing Solutions
01 1MIGALASTAT HYDROCHLORIDE
01 1India
01 1Active
01 1Complete
Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.
GDUFA
DMF Review : Complete
Rev. Date : 2022-06-09
Pay. Date : 2022-05-26
DMF Number : 36729
Submission : 2022-03-31
Status : Active
Type : II
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Lupin Manufacturing Solutions Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA.
They are recognized for Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.
One of their notable products is MIGALASTAT HYDROCHLORIDE, with a corresponding US DMF Number 36729.
Remarkably, this DMF maintains an Active status since its submission on March 31, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 09, 2022, and payment made on May 26, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
