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01 1222MF10097
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01 1WC-0597
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GDUFA
DMF Review : Reviewed
Rev. Date : 2013-05-13
Pay. Date : 2012-12-13
DMF Number : 20615
Submission : 2007-06-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11899
Submission : 1996-03-25
Status : Active
Type : II
Certificate Number : CEP 2022-263 - Rev 01
Issue Date : 2024-12-12
Type : Chemical
Substance Number : 1616
Status : Valid
Registration Number : 222MF10097
Registrant's Address : Strada Rivoltana Km 6/7 20053 Rodano Milano Italy
Initial Date of Registration : 2010-03-17
Latest Date of Registration :
NDC Package Code : 17337-0022
Start Marketing Date : 2012-12-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-07-26
Pay. Date : 2022-05-31
DMF Number : 37146
Submission : 2022-06-09
Status : Active
Type : II
Certificate Number : R1-CEP 2003-015 - Rev 05
Issue Date : 2023-04-03
Type : Chemical
Substance Number : 1616
Status : Valid
NDC Package Code : 17337-0022
Start Marketing Date : 2012-12-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-02-13
Pay. Date : 2019-02-08
DMF Number : 12754
Submission : 1997-11-14
Status : Active
Type : II
Certificate Number : R1-CEP 2003-120 - Rev 03
Issue Date : 2020-09-18
Type : Chemical
Substance Number : 1616
Status : Valid
NDC Package Code : 55512-0003
Start Marketing Date : 2009-09-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2258
Submission : 1974-04-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16458
Submission : 2003-02-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2259
Submission : 1974-04-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2452
Submission : 1975-05-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8361
Submission : 1989-12-27
Status : Inactive
Type : II
Date of Issue : 2024-11-14
Valid Till : 2027-11-13
Written Confirmation Number : WC-0597
Address of the Firm :
Certificate Number : R1-CEP 2005-051 - Rev 04
Issue Date : 2021-09-24
Type : Chemical
Substance Number : 1616
Status : Valid
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PharmaCompass offers a list of Hydroxyurea 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 Hydroxyurea manufacturer or Hydroxyurea supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Hydroxyurea manufacturer or Hydroxyurea supplier.
PharmaCompass also assists you with knowing the Hydroxyurea API Price utilized in the formulation of products. Hydroxyurea API Price is not always fixed or binding as the Hydroxyurea Price is obtained through a variety of data sources. The Hydroxyurea Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Hydroxyurea manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hydroxyurea, including repackagers and relabelers. The FDA regulates Hydroxyurea manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hydroxyurea 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 Hydroxyurea manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hydroxyurea supplier is an individual or a company that provides Hydroxyurea active pharmaceutical ingredient (API) or Hydroxyurea finished formulations upon request. The Hydroxyurea suppliers may include Hydroxyurea API manufacturers, exporters, distributors and traders.
click here to find a list of Hydroxyurea suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
We have 16 companies offering Hydroxyurea
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