KEY PRODUCTS
Enaltec Labs –Delivering complex APIs with precision, innovation, and global compliance.
01 1Enaltec Labs
01 1MIDODRINE HYDROCHLORIDE USP
01 1India
01 1Active
01 1Complete
Enaltec Labs –Delivering complex APIs with precision, innovation, and global compliance.
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-17
Pay. Date : 2016-09-26
DMF Number : 30806
Submission : 2016-09-27
Status : Active
Type : II
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Enaltec Labs Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and WHO-GMP.
They are recognized for Enaltec Labs –Delivering complex APIs with precision, innovation, and global compliance.
One of their notable products is MIDODRINE HYDROCHLORIDE USP, with a corresponding US DMF Number 30806.
Remarkably, this DMF maintains an Active status since its submission on September 27, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 17, 2017, and payment made on September 26, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
