01 1Erregierre SpA
02 1Blank
01 2GEPIRONE HYDROCHLORIDE
01 1Italy
02 1Blank
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14297
Submission : 1999-07-09
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 43349
Submission : 2025-12-27
Status : Active
Type : II
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PharmaCompass offers a list of Gepirone API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Gepirone manufacturer or Gepirone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Gepirone manufacturer or Gepirone supplier.
A Gepirone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gepirone, including repackagers and relabelers. The FDA regulates Gepirone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gepirone 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 Gepirone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Gepirone supplier is an individual or a company that provides Gepirone active pharmaceutical ingredient (API) or Gepirone finished formulations upon request. The Gepirone suppliers may include Gepirone API manufacturers, exporters, distributors and traders.
click here to find a list of Gepirone suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Gepirone DMF (Drug Master File) is a document detailing the whole manufacturing process of Gepirone active pharmaceutical ingredient (API) in detail. Different forms of Gepirone DMFs exist exist since differing nations have different regulations, such as Gepirone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gepirone DMF submitted to regulatory agencies in the US is known as a USDMF. Gepirone USDMF includes data on Gepirone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gepirone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gepirone suppliers with USDMF on PharmaCompass.
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