01 1Cipla
01 1SIPONIMOD ADIPIC ACID
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-01-06
Pay. Date : 2022-11-25
DMF Number : 37520
Submission : 2022-11-17
Status : Active
Type : II
A Siponimod manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Siponimod, including repackagers and relabelers. The FDA regulates Siponimod manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Siponimod 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 Siponimod manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Siponimod supplier is an individual or a company that provides Siponimod active pharmaceutical ingredient (API) or Siponimod finished formulations upon request. The Siponimod suppliers may include Siponimod API manufacturers, exporters, distributors and traders.
click here to find a list of Siponimod suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Siponimod DMF (Drug Master File) is a document detailing the whole manufacturing process of Siponimod active pharmaceutical ingredient (API) in detail. Different forms of Siponimod DMFs exist exist since differing nations have different regulations, such as Siponimod USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Siponimod DMF submitted to regulatory agencies in the US is known as a USDMF. Siponimod USDMF includes data on Siponimod's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Siponimod USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Siponimod suppliers with USDMF on PharmaCompass.
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