01 1Sifavitor srl
01 1CLODRONATE DISODIUM TETRAHYDRATE
01 1Italy
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24598
Submission : 2011-01-21
Status : Active
Type : II
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A Ostac manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ostac, including repackagers and relabelers. The FDA regulates Ostac manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ostac 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 Ostac manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Ostac supplier is an individual or a company that provides Ostac active pharmaceutical ingredient (API) or Ostac finished formulations upon request. The Ostac suppliers may include Ostac API manufacturers, exporters, distributors and traders.
click here to find a list of Ostac suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Ostac DMF (Drug Master File) is a document detailing the whole manufacturing process of Ostac active pharmaceutical ingredient (API) in detail. Different forms of Ostac DMFs exist exist since differing nations have different regulations, such as Ostac USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ostac DMF submitted to regulatory agencies in the US is known as a USDMF. Ostac USDMF includes data on Ostac's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ostac USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ostac suppliers with USDMF on PharmaCompass.
