Axplora- The partner of choice for complex APIs.
Reset all filters
01 1Axplora
02 1LGM Pharma
03 1Apicore LLC
04 1Archimica
05 1ChemPacific Corp
06 1DMFs Not Supported
07 2Emcure Pharmaceuticals
08 1Fareva
09 1Fresenius Kabi AB Brunna
10 1Fresenius Kabi Oncology Limited
11 1Hetero Drugs
12 1Kekule Pharma
13 2Natco Pharma
14 1Sakar Healthcare
15 1Shilpa Medicare
16 1Shivalik Rasayan
17 1Vannsh Life Sciences
18 1Viatris
Reset all filters
01 1Germany
02 12India
03 1Italy
04 1Luxembourg
05 1Sweden
06 3U.S.A
07 1Blank
Reset all filters
01 7Active
02 3Inactive
03 10Blank
01 7Valid
02 13Blank
Reset all filters
01 1230MF10027
02 19Blank
Reset all filters
01 1WC-0041
02 1WC-0115
03 1WC-0147
04 1WC-0226
05 1WC-0372
06 1WC-0372(1)
07 14Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-08-08
Pay. Date : 2012-12-17
DMF Number : 25933
Submission : 2012-03-27
Status : Active
Type : II
Certificate Number : R0-CEP 2018-265 - Rev 00
Issue Date : 2020-03-24
Type : Chemical
Substance Number : 542
Status : Valid
NDC Package Code : 46439-8734
Start Marketing Date : 2011-05-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Pharma Science Korea Co., Ltd.
Registration Date : 2022-06-08
Registration Number : 20220608-210-J-1307
Manufacturer Name : Farmabios SpA
Manufacturer Address : Via Pavia 1, Gropello Cairoli, 27027, Italy
Available Reg Filing : SAU |
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-05-29
Pay. Date : 2014-01-22
DMF Number : 25433
Submission : 2011-12-29
Status : Active
Type : II
Certificate Number : R1-CEP 2013-341 - Rev 01
Issue Date : 2023-08-31
Type : Chemical
Substance Number : 542
Status : Valid
Date of Issue : 2019-10-07
Valid Till : 2022-07-02
Written Confirmation Number : WC-0226
Address of the Firm :
NDC Package Code : 14593-865
Start Marketing Date : 2023-12-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
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 : Reviewed
Rev. Date : 2013-06-25
Pay. Date : 2012-11-21
DMF Number : 25667
Submission : 2012-02-02
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-06-10
Pay. Date : 2015-05-27
DMF Number : 23924
Submission : 2010-08-05
Status : Active
Type : II
Certificate Number : R1-CEP 2016-270 - Rev 00
Issue Date : 2023-05-17
Type : Chemical
Substance Number : 542
Status : Valid
NDC Package Code : 14096-147
Start Marketing Date : 2011-07-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-07-02
Pay. Date : 2012-12-19
DMF Number : 25491
Submission : 2011-12-07
Status : Active
Type : II
Certificate Number : R1-CEP 2011-339 - Rev 02
Issue Date : 2022-07-20
Type : Chemical
Substance Number : 542
Status : Valid
Registration Number : 230MF10027
Registrant's Address : Shilpa House, #12-6-214/A1, Hyderabad Road, Raichur-584135, Karnataka, India
Initial Date of Registration : 2018-02-15
Latest Date of Registration :
Date of Issue : 2019-07-05
Valid Till : 2022-07-02
Written Confirmation Number : WC-0147
Address of the Firm :
NDC Package Code : 82920-008
Start Marketing Date : 2022-08-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-09-03
Pay. Date : 2014-07-10
DMF Number : 27006
Submission : 2013-06-06
Status : Active
Type : II
Certificate Number : R1-CEP 2013-212 - Rev 00
Issue Date : 2020-04-28
Type : Chemical
Substance Number : 542
Status : Valid
NDC Package Code : 46014-1116
Start Marketing Date : 2014-06-02
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21126
Submission : 2007-12-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25836
Submission : 2012-04-01
Status : Inactive
Type : IV
NDC Package Code : 14593-865
Start Marketing Date : 2023-12-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24385
Submission : 2010-11-30
Status : Inactive
Type : II
Registrant Name : Fresenius Kabi Korea Co., Ltd.
Registration Date : 2018-07-26
Registration Number : 20180726-210-J-248
Manufacturer Name : Fresenius Kabi Oncology Ltd.
Manufacturer Address : D-35, Industrial Area, Kalyani, Dist Nadia, West Bengal, INDIA
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25393
Submission : 2011-10-18
Status : Inactive
Type : II
Certificate Number : CEP 2010-374 - Rev 07
Issue Date : 2023-10-13
Type : Chemical
Substance Number : 542
Status : Valid
Date of Issue : 2019-07-08
Valid Till : 2022-07-07
Written Confirmation Number : WC-0115
Address of the Firm :
Date of Issue : 2019-10-07
Valid Till : 2022-06-12
Written Confirmation Number : WC-0372
Address of the Firm :
Date of Issue : 2018-12-24
Valid Till : 2019-06-13
Written Confirmation Number : WC-0372(1)
Address of the Firm :
Certificate Number : R0-CEP 2021-356 - Rev 00
Issue Date : 2022-12-01
Type : Chemical
Substance Number : 542
Status : Valid
Date of Issue : 2022-09-16
Valid Till : 2025-08-08
Written Confirmation Number : WC-0041
Address of the Firm :
70
PharmaCompass offers a list of Busulfan API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Busulfan manufacturer or Busulfan supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Busulfan manufacturer or Busulfan supplier.
PharmaCompass also assists you with knowing the Busulfan API Price utilized in the formulation of products. Busulfan API Price is not always fixed or binding as the Busulfan Price is obtained through a variety of data sources. The Busulfan Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Busulfan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Busulfan, including repackagers and relabelers. The FDA regulates Busulfan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Busulfan 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 Busulfan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Busulfan supplier is an individual or a company that provides Busulfan active pharmaceutical ingredient (API) or Busulfan finished formulations upon request. The Busulfan suppliers may include Busulfan API manufacturers, exporters, distributors and traders.
click here to find a list of Busulfan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
We have 17 companies offering Busulfan
Get in contact with the supplier of your choice: