01 1Zhejiang Apeloa Jiayuan Pharmaceutical
01 1LAROPIPRANT
01 1China
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26304
Submission : 2012-07-30
Status : Active
Type : II
A LAROPIPRANT manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of LAROPIPRANT, including repackagers and relabelers. The FDA regulates LAROPIPRANT manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. LAROPIPRANT 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 LAROPIPRANT supplier is an individual or a company that provides LAROPIPRANT active pharmaceutical ingredient (API) or LAROPIPRANT finished formulations upon request. The LAROPIPRANT suppliers may include LAROPIPRANT API manufacturers, exporters, distributors and traders.
click here to find a list of LAROPIPRANT suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A LAROPIPRANT DMF (Drug Master File) is a document detailing the whole manufacturing process of LAROPIPRANT active pharmaceutical ingredient (API) in detail. Different forms of LAROPIPRANT DMFs exist exist since differing nations have different regulations, such as LAROPIPRANT USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A LAROPIPRANT DMF submitted to regulatory agencies in the US is known as a USDMF. LAROPIPRANT USDMF includes data on LAROPIPRANT's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The LAROPIPRANT USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of LAROPIPRANT suppliers with USDMF on PharmaCompass.
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