Axplora- The partner of choice for complex APIs.
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
01 1Germany
02 12India
03 1Italy
04 1Luxembourg
05 1Sweden
06 3U.S.A
07 1Blank
01 7Active
02 3Inactive
03 10Blank
01 7Valid
02 13Blank
01 1230MF10027
02 19Blank
01 1WC-0041
02 1WC-0115
03 1WC-0147
04 1WC-0226
05 1WC-0372
06 1WC-0372(1)
07 14Blank
Axplora- The partner of choice for complex APIs.
Click Us!
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 : 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 : 2024-12-31
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 : 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 : 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 : 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
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
We have 17 companies offering Busulfan
Get in contact with the supplier of your choice:
LOOKING FOR A SUPPLIER?
