01 1Megafine Pharma (P) Limited
01 1CINACALCET HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-23
Pay. Date : 2012-12-24
DMF Number : 24881
Submission : 2011-04-22
Status : Active
Type : II
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Megafine Pharma P Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
They are recognized for Megafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.
One of their notable products is CINACALCET HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE), with a corresponding US DMF Number 24881.
Remarkably, this DMF maintains an Active status since its submission on April 22, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 23, 2013, and payment made on December 24, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
