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
A Thulium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Thulium, including repackagers and relabelers. The FDA regulates Thulium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Thulium 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 Thulium supplier is an individual or a company that provides Thulium active pharmaceutical ingredient (API) or Thulium finished formulations upon request. The Thulium suppliers may include Thulium API manufacturers, exporters, distributors and traders.
click here to find a list of Thulium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Thulium DMF (Drug Master File) is a document detailing the whole manufacturing process of Thulium active pharmaceutical ingredient (API) in detail. Different forms of Thulium DMFs exist exist since differing nations have different regulations, such as Thulium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Thulium DMF submitted to regulatory agencies in the US is known as a USDMF. Thulium USDMF includes data on Thulium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Thulium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Thulium suppliers with USDMF on PharmaCompass.
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