01 2Pfizer Inc
01 2TROLEANDOMYCIN
01 2U.S.A
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13708
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13491
Submission : 1998-09-01
Status : Inactive
Type : II
A Troleandomycin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Troleandomycin, including repackagers and relabelers. The FDA regulates Troleandomycin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Troleandomycin 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 Troleandomycin supplier is an individual or a company that provides Troleandomycin active pharmaceutical ingredient (API) or Troleandomycin finished formulations upon request. The Troleandomycin suppliers may include Troleandomycin API manufacturers, exporters, distributors and traders.
click here to find a list of Troleandomycin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Troleandomycin DMF (Drug Master File) is a document detailing the whole manufacturing process of Troleandomycin active pharmaceutical ingredient (API) in detail. Different forms of Troleandomycin DMFs exist exist since differing nations have different regulations, such as Troleandomycin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Troleandomycin DMF submitted to regulatory agencies in the US is known as a USDMF. Troleandomycin USDMF includes data on Troleandomycin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Troleandomycin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Troleandomycin suppliers with USDMF on PharmaCompass.
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