KEY PRODUCTS
Enaltec Labs –Delivering complex APIs with precision, innovation, and global compliance.
01 1Enaltec Labs
01 1VARENICLINE TARTRATE
01 1India
01 1Active
01 1Complete
Enaltec Labs –Delivering complex APIs with precision, innovation, and global compliance.
GDUFA
DMF Review : Complete
Rev. Date : 2018-08-29
Pay. Date : 2018-07-31
DMF Number : 32835
Submission : 2018-06-19
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 VARENICLINE TARTRATE, with a corresponding US DMF Number 32835.
Remarkably, this DMF maintains an Active status since its submission on June 19, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 29, 2018, and payment made on July 31, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
