Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Polpharma
02 1LGM Pharma
03 1Sichuan Elixir Pharmaceuticals
04 1Alembic Pharmaceuticals Limited
05 1Aurobindo Pharma Limited
06 1Beijing Mesochem Technology
07 2Guangdong Raffles PharmaTech Co Ltd
08 1Hangzhou Longshine Bio-Tech
09 1Hetero Drugs
10 2MSN Laboratories
11 1Shenzhen Haorui
12 1Shenzhen HwaGen Pharmaceutical
13 1Viatris
14 1Zhejiang Multinpharma
15 2Blank
01 8China
02 5India
03 1Poland
04 2U.S.A
05 2Blank
01 6Active
02 12Blank
01 18Blank
01 18Blank
01 1WC-0349
02 17Blank
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40493
Submission : 2024-09-29
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-10-18
Pay. Date : 2022-09-12
DMF Number : 37504
Submission : 2022-09-13
Status : Active
Type : II
NDC Package Code : 59651-710
Start Marketing Date : 2024-01-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31589
Submission : 2017-03-31
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 : 54893-0062
Start Marketing Date : 2017-03-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-03-31
Pay. Date : 2022-01-06
DMF Number : 35525
Submission : 2020-12-31
Status : Active
Type : II
NDC Package Code : 54893-0062
Start Marketing Date : 2017-03-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39561
Submission : 2024-06-19
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40250
Submission : 2024-08-23
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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