01 1Irvine Scientific Sales Company
01 1IS MAB-V™ WITH IRON CHELATE (PRODUCT NUMBER 99435)
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20839
Submission : 2007-09-06
Status : Active
Type : II
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PharmaCompass offers a list of Thulium 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 Thulium manufacturer or Thulium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Thulium manufacturer or Thulium supplier.
PharmaCompass also assists you with knowing the Thulium API Price utilized in the formulation of products. Thulium API Price is not always fixed or binding as the Thulium Price is obtained through a variety of data sources. The Thulium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A TM manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of TM, including repackagers and relabelers. The FDA regulates TM manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. TM API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A TM supplier is an individual or a company that provides TM active pharmaceutical ingredient (API) or TM finished formulations upon request. The TM suppliers may include TM API manufacturers, exporters, distributors and traders.
click here to find a list of TM suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A TM DMF (Drug Master File) is a document detailing the whole manufacturing process of TM active pharmaceutical ingredient (API) in detail. Different forms of TM DMFs exist exist since differing nations have different regulations, such as TM USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A TM DMF submitted to regulatory agencies in the US is known as a USDMF. TM USDMF includes data on TM's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The TM USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of TM suppliers with USDMF on PharmaCompass.
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