KEY PRODUCTS
PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
01 1PMC Isochem
01 1AMIODARONE HYDROCHLORIDE
01 1France
01 1Active
01 1Complete
PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-26
Pay. Date : 2013-02-13
DMF Number : 7617
Submission : 1988-08-02
Status : Active
Type : II
20
Pmc Isochem, based in France, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
They are recognized for PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
One of their notable products is AMIODARONE HYDROCHLORIDE, with a corresponding US DMF Number 7617.
Remarkably, this DMF maintains an Active status since its submission on August 02, 1988, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 26, 2013, and payment made on February 13, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
