Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Polpharma
02 1Arevipharma
03 1Beijing Sjar Technology Development
04 1Hangzhou Longshine Bio-Tech
05 1MSN Laboratories
06 1Shanghai Hope Chem
01 3China
02 1Germany
03 1India
04 1Poland
01 1Active
02 5Blank
01 6Blank
01 6Blank
01 1WC-0349
02 5Blank
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-06-23
Pay. Date : 2022-06-10
DMF Number : 36745
Submission : 2022-01-31
Status : Active
Type : II
Date of Issue : 2022-09-02
Valid Till : 2025-05-05
Written Confirmation Number : WC-0349
Address of the Firm :
NDC Package Code : 54893-0120
Start Marketing Date : 2022-01-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Gilteritinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gilteritinib, including repackagers and relabelers. The FDA regulates Gilteritinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gilteritinib API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Gilteritinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gilteritinib supplier is an individual or a company that provides Gilteritinib active pharmaceutical ingredient (API) or Gilteritinib finished formulations upon request. The Gilteritinib suppliers may include Gilteritinib API manufacturers, exporters, distributors and traders.
click here to find a list of Gilteritinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
We have 6 companies offering Gilteritinib
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