Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
01 1Pfizer CentreOne
01 1NOVOBIOCIN SODIUM
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13334
Submission : 1998-09-01
Status : Active
Type : II
A Novobiocin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Novobiocin, including repackagers and relabelers. The FDA regulates Novobiocin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Novobiocin 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 Novobiocin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Novobiocin supplier is an individual or a company that provides Novobiocin active pharmaceutical ingredient (API) or Novobiocin finished formulations upon request. The Novobiocin suppliers may include Novobiocin API manufacturers, exporters, distributors and traders.
click here to find a list of Novobiocin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Novobiocin DMF (Drug Master File) is a document detailing the whole manufacturing process of Novobiocin active pharmaceutical ingredient (API) in detail. Different forms of Novobiocin DMFs exist exist since differing nations have different regulations, such as Novobiocin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Novobiocin DMF submitted to regulatory agencies in the US is known as a USDMF. Novobiocin USDMF includes data on Novobiocin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Novobiocin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Novobiocin suppliers with USDMF on PharmaCompass.
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