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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSeqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

GDUFA

DMF Review : Complete

Rev. Date : 2018-09-17

Pay. Date : 2018-09-12

DMF Number : 28295

Submission : 2014-08-12

Status : Active

Type : II

Seqens Company Banner

Looking for Drug Master Files (DMF) for 28295 of Polycarbon Industries Inc Dba Pci Synthesis

Looking for Drug Master Files (DMF) for 28295 of Polycarbon Industries Inc Dba Pci Synthesis 1

20

Polycarbon Industries Inc Dba Pci Synthesis, based in France, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

One of their notable products is PODOPHYLLOTOXIN 184 NON-STERILE BULK DRUG SUBSTANCE, with a corresponding US DMF Number 28295.

Remarkably, this DMF maintains an Active status since its submission on August 12, 2014, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of September 17, 2018, and payment made on September 12, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II