01 1Archimica
02 3Bristol Myers Squibb
03 1CHEMSPEC CHEMICALS PVT LTD
04 1Fermenta Biotech Limited
05 2Olon S.p.A
06 1Qilu Tianhe Pharmaceutical Co., Ltd.
01 1HYDREA
02 5HYDROXYUREA
03 1HYDROXYUREA BY OLMACO OF EMPERNON,FRANCE (FORMERLY HELD BY OLMACO)
04 1HYDROXYUREA LYOPHILIZED POWDER
05 1HYDROXYUREA USP (NON-STERILE BULK)
01 1China
02 2India
03 3Italy
04 3U.S.A
01 4Active
02 5Inactive
01 3Complete
02 6Blank
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-13
Pay. Date : 2019-02-08
DMF Number : 12754
Submission : 1997-11-14
Status : Active
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 : 2259
Submission : 1974-04-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8361
Submission : 1989-12-27
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 : 2258
Submission : 1974-04-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11899
Submission : 1996-03-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-07-26
Pay. Date : 2022-05-31
DMF Number : 37146
Submission : 2022-06-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-13
Pay. Date : 2012-12-13
DMF Number : 20615
Submission : 2007-06-15
Status : Active
Type : II
13
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.
A Hydroxyurea DMF (Drug Master File) is a document detailing the whole manufacturing process of Hydroxyurea active pharmaceutical ingredient (API) in detail. Different forms of Hydroxyurea DMFs exist exist since differing nations have different regulations, such as Hydroxyurea USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hydroxyurea DMF submitted to regulatory agencies in the US is known as a USDMF. Hydroxyurea USDMF includes data on Hydroxyurea's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hydroxyurea USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hydroxyurea suppliers with USDMF on PharmaCompass.
We have 6 companies offering Hydroxyurea
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