01 1Mallinckrodt Pharmaceuticals
01 1BUPRENORPHINE HYDROCHLORIDE USP, CODE 3210
01 1Ireland
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-30
Pay. Date : 2012-11-30
DMF Number : 24927
Submission : 2012-05-02
Status : Active
Type : II
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Specgx Llc, based in Ireland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is BUPRENORPHINE HYDROCHLORIDE USP, CODE 3210, with a corresponding US DMF Number 24927.
Remarkably, this DMF maintains an Active status since its submission on May 02, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 30, 2013, and payment made on November 30, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
