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10 1Fresenius Kabi AB Brunna
11 1Fresenius Kabi Oncology Limited
12 1Hetero Drugs
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01 120180726-210-J-248
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01 114096-147
02 114593-865
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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
NDC Package Code : 46439-8734
Start Marketing Date : 2011-05-01
End Marketing Date : 2025-12-31
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 : 2025-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
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 : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Product Not Available For Sales
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 : 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
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
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 Myelosan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Myelosan, including repackagers and relabelers. The FDA regulates Myelosan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Myelosan 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 Myelosan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Myelosan supplier is an individual or a company that provides Myelosan active pharmaceutical ingredient (API) or Myelosan finished formulations upon request. The Myelosan suppliers may include Myelosan API manufacturers, exporters, distributors and traders.
click here to find a list of Myelosan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
We have 19 companies offering Myelosan
Get in contact with the supplier of your choice: