01 1Pfizer Inc
01 1ACTIVATED CALICHEAMICIN DERIVATIVE
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29645
Submission : 2015-12-11
Status : Active
Type : II
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PharmaCompass offers a list of Calicheamicin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Calicheamicin manufacturer or Calicheamicin supplier for your needs.
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A Calicheamicin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calicheamicin, including repackagers and relabelers. The FDA regulates Calicheamicin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calicheamicin 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 Calicheamicin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Calicheamicin supplier is an individual or a company that provides Calicheamicin active pharmaceutical ingredient (API) or Calicheamicin finished formulations upon request. The Calicheamicin suppliers may include Calicheamicin API manufacturers, exporters, distributors and traders.
click here to find a list of Calicheamicin suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Calicheamicin DMF (Drug Master File) is a document detailing the whole manufacturing process of Calicheamicin active pharmaceutical ingredient (API) in detail. Different forms of Calicheamicin DMFs exist exist since differing nations have different regulations, such as Calicheamicin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Calicheamicin DMF submitted to regulatory agencies in the US is known as a USDMF. Calicheamicin USDMF includes data on Calicheamicin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Calicheamicin USDMF is kept confidential to protect the manufacturer’s intellectual property.
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