01 1Recipharm AB
02 1Blank
01 2TULOBUTEROL BASE
01 1Sweden
02 1Blank
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21750
Submission : 2008-06-27
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6648
Submission : 1986-10-17
Status : Inactive
Type : II
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A Tulobuterol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tulobuterol, including repackagers and relabelers. The FDA regulates Tulobuterol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tulobuterol 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 Tulobuterol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tulobuterol supplier is an individual or a company that provides Tulobuterol active pharmaceutical ingredient (API) or Tulobuterol finished formulations upon request. The Tulobuterol suppliers may include Tulobuterol API manufacturers, exporters, distributors and traders.
click here to find a list of Tulobuterol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tulobuterol DMF (Drug Master File) is a document detailing the whole manufacturing process of Tulobuterol active pharmaceutical ingredient (API) in detail. Different forms of Tulobuterol DMFs exist exist since differing nations have different regulations, such as Tulobuterol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tulobuterol DMF submitted to regulatory agencies in the US is known as a USDMF. Tulobuterol USDMF includes data on Tulobuterol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tulobuterol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tulobuterol suppliers with USDMF on PharmaCompass.
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