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01 2Abiraterone Acetate
02 2Atomoxetin Hydrochloride
03 2Bendamustine Hydrochloride
04 2Bortezomib
05 1CAS 284461-73-0
06 2Cabozantinib
07 2Capecitabine
08 2Cetrorelix Acetate
09 2Dapagliflozin Propanediol Monohydrate
10 2Dasatinib
11 2Deferasirox
12 2Degarelix Acetate
13 2Enzalutamide
14 2Erlotinib Hydrochloride
15 2Fulvestrant
16 2Gefitinib
17 2Imatinib Mesylate
18 2Lapatinib Ditosylate
19 2Micafungin
20 2Nintedanib Esylate
21 2Olaparib
22 2Pazopanib Hydrochloride
23 2Pemetrexed Disodium
24 2Pomalidomide
25 1Relugolix
26 2Rosuvastatin Calcium
27 2Rucaparib Camsylate
28 2Sorafenib
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01 3Active
02 51Blank
01 2Valid
02 52Blank
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01 54Blank
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01 26WC-0340
02 26WC-340n
03 2Blank
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01 54Blank
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01 176361-0002
02 176361-0003
03 176361-0004
04 176361-0005
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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-10-24
Pay. Date : 2024-09-11
DMF Number : 40067
Submission : 2024-09-23
Status : Active
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-04-14
Written Confirmation Number : WC-0340
Address of the Firm :
NDC Package Code : 76361-0002
Start Marketing Date : 2024-04-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-10-29
Pay. Date : 2024-08-13
DMF Number : 40208
Submission : 2024-09-20
Status : Active
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-04-14
Written Confirmation Number : WC-0340
Address of the Firm :
NDC Package Code : 76361-0003
Start Marketing Date : 2024-04-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R0-CEP 2019-334 - Rev 00
Issue Date : 2022-02-04
Type : Chemical
Substance Number : 2637
Status : Valid
Date of Issue : 2022-09-30
Valid Till : 2025-04-14
Written Confirmation Number : WC-0340
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2022-478 - Rev 00
Issue Date : 2024-11-06
Type : Chemical
Substance Number : 2931
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-08-22
Pay. Date : 2024-07-19
DMF Number : 40209
Submission : 2024-07-25
Status : Active
Type : II
NDC Package Code : 76361-0004
Start Marketing Date : 2024-04-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Date of Issue : 2022-09-30
Valid Till : 2025-04-14
Written Confirmation Number : WC-0340
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Date of Issue : 2022-09-30
Valid Till : 2025-04-14
Written Confirmation Number : WC-340n
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Date of Issue : 2022-09-30
Valid Till : 2025-04-14
Written Confirmation Number : WC-0340
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Date of Issue : 2022-09-30
Valid Till : 2025-04-14
Written Confirmation Number : WC-340n
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Date of Issue : 2022-09-30
Valid Till : 2025-04-14
Written Confirmation Number : WC-0340
Address of the Firm :
Bdr Lifesciences is a supplier offers 31 products (APIs, Excipients or Intermediates).
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