Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Polpharma
02 1Biophore India Pharmaceuticals Pvt Ltd
03 1Metrochem API Private Limited
04 1Porton Pharma Solutions
05 1BrightGene Bio-Medical Technology Co.,Ltd
06 1Cipla
07 1Glenmark Life Sciences
08 1HONOUR LAB LTD
09 1MSN Laboratories
10 1Optimus Pharma
11 1Shanghai Desano Chemical Pharmaceutical Co., Ltd.
01 10ISAVUCONAZONIUM SULFATE
02 1ISAVUCONAZONIUM SULFATE API, NON-STERILE DRUG SUBSTANCE
01 3China
02 7India
03 1Poland
01 11Active
01 6Complete
02 5Blank
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38964
Submission : 2023-10-04
Status : Active
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-08
Pay. Date : 2023-09-28
DMF Number : 38781
Submission : 2023-09-22
Status : Active
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36974
Submission : 2022-05-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-09-25
Pay. Date : 2024-08-28
DMF Number : 39012
Submission : 2023-11-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-04-25
Pay. Date : 2024-03-07
DMF Number : 38502
Submission : 2023-10-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-01-26
Pay. Date : 2023-12-13
DMF Number : 39151
Submission : 2023-12-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-06-28
Pay. Date : 2024-06-13
DMF Number : 38251
Submission : 2023-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-02-12
Pay. Date : 2024-01-05
DMF Number : 38784
Submission : 2023-09-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39496
Submission : 2024-03-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39777
Submission : 2024-03-28
Status : Active
Type : II
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