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01 1TAPI Technology & API Services
01 1ZOLEDRONATE DISODIUM
01 1Israel
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-02-09
Pay. Date : 2017-09-01
DMF Number : 32008
Submission : 2017-12-31
Status : Active
Type : II
A Zoledronate Disodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zoledronate Disodium, including repackagers and relabelers. The FDA regulates Zoledronate Disodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zoledronate Disodium 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 Zoledronate Disodium supplier is an individual or a company that provides Zoledronate Disodium active pharmaceutical ingredient (API) or Zoledronate Disodium finished formulations upon request. The Zoledronate Disodium suppliers may include Zoledronate Disodium API manufacturers, exporters, distributors and traders.
click here to find a list of Zoledronate Disodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Zoledronate Disodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Zoledronate Disodium active pharmaceutical ingredient (API) in detail. Different forms of Zoledronate Disodium DMFs exist exist since differing nations have different regulations, such as Zoledronate Disodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Zoledronate Disodium DMF submitted to regulatory agencies in the US is known as a USDMF. Zoledronate Disodium USDMF includes data on Zoledronate Disodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zoledronate Disodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Zoledronate Disodium suppliers with USDMF on PharmaCompass.
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