KEY PRODUCTS
Synthokem Labs specializes in producing APIs and intermediates for the global pharma industry.
01 1Synthokem Labs
01 1GUAIFENESIN USP
01 1India
01 1Active
01 1Complete
Synthokem Labs specializes in producing APIs and intermediates for the global pharma industry.
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-08
Pay. Date : 2013-09-12
DMF Number : 10413
Submission : 1993-08-13
Status : Active
Type : II
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Synthokem 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 Synthokem Labs specializes in producing APIs and intermediates for the global pharma industry.
One of their notable products is GUAIFENESIN USP, with a corresponding US DMF Number 10413.
Remarkably, this DMF maintains an Active status since its submission on August 13, 1993, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 08, 2014, and payment made on September 12, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
