01 1Abiogen Pharma Spa
01 1SODIUM NERIDRONATE HEMIHYDRATE
01 1Italy
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41313
Submission : 2025-11-03
Status : Active
Type : II
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PharmaCompass offers a list of Neridronate 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 Neridronate manufacturer or Neridronate supplier for your needs.
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A Neridronate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Neridronate, including repackagers and relabelers. The FDA regulates Neridronate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Neridronate 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 Neridronate supplier is an individual or a company that provides Neridronate active pharmaceutical ingredient (API) or Neridronate finished formulations upon request. The Neridronate suppliers may include Neridronate API manufacturers, exporters, distributors and traders.
click here to find a list of Neridronate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Neridronate DMF (Drug Master File) is a document detailing the whole manufacturing process of Neridronate active pharmaceutical ingredient (API) in detail. Different forms of Neridronate DMFs exist exist since differing nations have different regulations, such as Neridronate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Neridronate DMF submitted to regulatory agencies in the US is known as a USDMF. Neridronate USDMF includes data on Neridronate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Neridronate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Neridronate suppliers with USDMF on PharmaCompass.
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