01 1Boehringer Ingelheim GmbH
01 1LOBELINE SULFATE
01 1Germany
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10586
Submission : 1993-11-22
Status : Inactive
Type : II
A Lobeline Sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lobeline Sulfate, including repackagers and relabelers. The FDA regulates Lobeline Sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lobeline Sulfate 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 Lobeline Sulfate supplier is an individual or a company that provides Lobeline Sulfate active pharmaceutical ingredient (API) or Lobeline Sulfate finished formulations upon request. The Lobeline Sulfate suppliers may include Lobeline Sulfate API manufacturers, exporters, distributors and traders.
click here to find a list of Lobeline Sulfate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lobeline Sulfate DMF (Drug Master File) is a document detailing the whole manufacturing process of Lobeline Sulfate active pharmaceutical ingredient (API) in detail. Different forms of Lobeline Sulfate DMFs exist exist since differing nations have different regulations, such as Lobeline Sulfate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lobeline Sulfate DMF submitted to regulatory agencies in the US is known as a USDMF. Lobeline Sulfate USDMF includes data on Lobeline Sulfate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lobeline Sulfate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lobeline Sulfate suppliers with USDMF on PharmaCompass.
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