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01 1TAPI Technology & API Services
01 1LR-103
01 1Israel
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18169
Submission : 2005-03-15
Status : Inactive
Type : II
A Lr-103 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lr-103, including repackagers and relabelers. The FDA regulates Lr-103 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lr-103 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 Lr-103 supplier is an individual or a company that provides Lr-103 active pharmaceutical ingredient (API) or Lr-103 finished formulations upon request. The Lr-103 suppliers may include Lr-103 API manufacturers, exporters, distributors and traders.
click here to find a list of Lr-103 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lr-103 DMF (Drug Master File) is a document detailing the whole manufacturing process of Lr-103 active pharmaceutical ingredient (API) in detail. Different forms of Lr-103 DMFs exist exist since differing nations have different regulations, such as Lr-103 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lr-103 DMF submitted to regulatory agencies in the US is known as a USDMF. Lr-103 USDMF includes data on Lr-103's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lr-103 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lr-103 suppliers with USDMF on PharmaCompass.
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