01 1INTERNATIONAL SPECIALTY PRODUCTS
01 1ALLANTOIN
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15310
Submission : 2001-02-21
Status : Active
Type : II
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A Hemocane manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hemocane, including repackagers and relabelers. The FDA regulates Hemocane manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hemocane 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 Hemocane manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Hemocane supplier is an individual or a company that provides Hemocane active pharmaceutical ingredient (API) or Hemocane finished formulations upon request. The Hemocane suppliers may include Hemocane API manufacturers, exporters, distributors and traders.
click here to find a list of Hemocane suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Hemocane DMF (Drug Master File) is a document detailing the whole manufacturing process of Hemocane active pharmaceutical ingredient (API) in detail. Different forms of Hemocane DMFs exist exist since differing nations have different regulations, such as Hemocane USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hemocane DMF submitted to regulatory agencies in the US is known as a USDMF. Hemocane USDMF includes data on Hemocane's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hemocane USDMF is kept confidential to protect the manufacturer’s intellectual property.
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