01 1SMS Pharmaceuticals
01 1ELETRIPTAN HYDROBROMIDE MONOHYDRATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-04
Pay. Date : 2013-09-25
DMF Number : 24905
Submission : 2011-05-02
Status : Active
Type : II
A Eletriptan Hydrobromide Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eletriptan Hydrobromide Monohydrate, including repackagers and relabelers. The FDA regulates Eletriptan Hydrobromide Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eletriptan Hydrobromide Monohydrate 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 Eletriptan Hydrobromide Monohydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Eletriptan Hydrobromide Monohydrate supplier is an individual or a company that provides Eletriptan Hydrobromide Monohydrate active pharmaceutical ingredient (API) or Eletriptan Hydrobromide Monohydrate finished formulations upon request. The Eletriptan Hydrobromide Monohydrate suppliers may include Eletriptan Hydrobromide Monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Eletriptan Hydrobromide Monohydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Eletriptan Hydrobromide Monohydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Eletriptan Hydrobromide Monohydrate active pharmaceutical ingredient (API) in detail. Different forms of Eletriptan Hydrobromide Monohydrate DMFs exist exist since differing nations have different regulations, such as Eletriptan Hydrobromide Monohydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Eletriptan Hydrobromide Monohydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Eletriptan Hydrobromide Monohydrate USDMF includes data on Eletriptan Hydrobromide Monohydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Eletriptan Hydrobromide Monohydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Eletriptan Hydrobromide Monohydrate suppliers with USDMF on PharmaCompass.
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