01 1Qilu Tianhe Pharmaceutical Co., Ltd.
01 1BUFLOMEDIL HYDROCHLORIDE (NON STERILE API)
01 1China
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22039
Submission : 2008-09-28
Status : Inactive
Type : II
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A Loftyl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Loftyl, including repackagers and relabelers. The FDA regulates Loftyl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Loftyl 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 Loftyl supplier is an individual or a company that provides Loftyl active pharmaceutical ingredient (API) or Loftyl finished formulations upon request. The Loftyl suppliers may include Loftyl API manufacturers, exporters, distributors and traders.
click here to find a list of Loftyl suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Loftyl DMF (Drug Master File) is a document detailing the whole manufacturing process of Loftyl active pharmaceutical ingredient (API) in detail. Different forms of Loftyl DMFs exist exist since differing nations have different regulations, such as Loftyl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Loftyl DMF submitted to regulatory agencies in the US is known as a USDMF. Loftyl USDMF includes data on Loftyl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Loftyl USDMF is kept confidential to protect the manufacturer’s intellectual property.
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