WCK 5222, Wockhardt receives QIDP status for its new drug WCK 5222 from USFDA

WCK 5222

Watch this post as I get to the structure…………..

DEC2015

Wockhardt has received Qualified Infectious Disease Product (QIDP) status for its new drug WCK 5222,  a product from its breakthrough New Drug Discovery program in Anti Infectives from the US Food and Drug Administration (FDA).
This is the fourth product from the company to receive this coveted status. During last year, the company has received approval for WCK 771 & WCK 2349 and in early this year approval was received for WCK 4873. The only company globally to receive QIDP status for 4 drugs from US FDA.
Wockhardt is one of the few companies with end to end integrated capabilities for its products, starting with the manufacture of the oral and sterile API’s, the dose forms and marketing through wholly owned subsidiary in the US, enabling the company to capture maximum value.

Ten compounds generally represented by a general Formula (I) were used and are as follows:

(a) Sodium salt of ir ns-7-oxo-6-sulphooxy-l ,6-diazabicyclo[3.2.1]-octane-2-carbonitrile (Compound A);

(b) trans-sulphuric acid mono-[2-(5-carboxamido)-[l ,3,4]-oxadiazol-2-yl)-7-oxo-l,6-diazabicyclo[3.2.1]-octan-6-yl] ester (Compound B);

(c) trans-sulphuric acid mono-[2-(5-(piperidin-4-yl)-[l ,3,4]-oxadiazol-2-yl)-7-oxo-l,6-diazabicyclo[3.2.1]-octan-6-yl] ester (Compound C);

(d) trans-sulphuric acid mono-[2-(5-azetidin-3-ylmethyl-[l ,3,4]-oxadiazol-2-yl)-7-oxo-l,6-diazabicyclo[3.2.1]-octan-6-yl] ester (Compound D);

(e) (25,5i?)-7-Oxo-6-sulphooxy-2-[N’-((i?)-piperidine-3-carbonyl)-hydrazinocarbonyl] -1,6-diaza-bicyclo[3.2.1]octane (Compound E);

(f) (25, 5i?)-7-Oxo-N-[(25)-pyrrolidin-2-ylmethoxy]-6-(sulfooxy)-l,6-diaza bicyclo [3.2.1] octane-2-carboxamide (Compound F);

(g) (25,5i?)-7-Oxo-6-sulphooxy-2-[N’-((i?)-pyrrolidine-3-carbonyl)-hydrazinocarbonyl]-l ,6-diaza -bicyclo[3.2.1]octane (Compound G);

(h) (25,5i?)-7-Oxo-N-[(25)-piperidine-2-ylmethyloxy]-6-(sulfooxy)-l ,6-diazabicyclo

octane-2-carboxamide (Compound H);

(i) trans-sulphuric acid mono-[2-(5-((5)-l-amino-ethyl)-[l ,3,4]-oxadiazol-2-yl)-7-oxo-l,6-diazabicyclo[3.2.1]-octan-6-yl] ester (Compound I); and

j) trans-sulphuric acid mono-[2-(5-((5)-pyrrolidin-2-yl)-[l,3,4]-oxadiazol-2-yl)-7-oxo-l,6-diazabicyclo[3.2.1]-octan-6-yl] ester (Compound J).

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