ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Curia
01 1ARGATROBAN HYDRATE (NON-STERILE BULK) DRUG SUBSTANCE
02 1ARGATROBAN MONOHYDRATE
01 2U.S.A
01 2Active
01 2Complete
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2019-12-27
Pay. Date : 2019-12-20
DMF Number : 20709
Submission : 2007-07-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-10-15
Pay. Date : 2024-09-10
DMF Number : 40227
Submission : 2024-08-30
Status : Active
Type : II
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PharmaCompass offers a list of Argatroban Monohydrate 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 Argatroban Monohydrate manufacturer or Argatroban Monohydrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Argatroban Monohydrate manufacturer or Argatroban Monohydrate supplier.
PharmaCompass also assists you with knowing the Argatroban Monohydrate API Price utilized in the formulation of products. Argatroban Monohydrate API Price is not always fixed or binding as the Argatroban Monohydrate Price is obtained through a variety of data sources. The Argatroban Monohydrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Argatroban Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Argatroban Monohydrate, including repackagers and relabelers. The FDA regulates Argatroban Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Argatroban Monohydrate 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 Argatroban Monohydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Argatroban Monohydrate supplier is an individual or a company that provides Argatroban Monohydrate active pharmaceutical ingredient (API) or Argatroban Monohydrate finished formulations upon request. The Argatroban Monohydrate suppliers may include Argatroban Monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Argatroban Monohydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Argatroban Monohydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Argatroban Monohydrate active pharmaceutical ingredient (API) in detail. Different forms of Argatroban Monohydrate DMFs exist exist since differing nations have different regulations, such as Argatroban Monohydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Argatroban Monohydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Argatroban Monohydrate USDMF includes data on Argatroban Monohydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Argatroban Monohydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Argatroban Monohydrate suppliers with USDMF on PharmaCompass.
We have 2 companies offering Argatroban Monohydrate
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