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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 zoledronic acid anhydrous manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of zoledronic acid anhydrous, including repackagers and relabelers. The FDA regulates zoledronic acid anhydrous manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. zoledronic acid anhydrous 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 zoledronic acid anhydrous supplier is an individual or a company that provides zoledronic acid anhydrous active pharmaceutical ingredient (API) or zoledronic acid anhydrous finished formulations upon request. The zoledronic acid anhydrous suppliers may include zoledronic acid anhydrous API manufacturers, exporters, distributors and traders.
click here to find a list of zoledronic acid anhydrous suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A zoledronic acid anhydrous DMF (Drug Master File) is a document detailing the whole manufacturing process of zoledronic acid anhydrous active pharmaceutical ingredient (API) in detail. Different forms of zoledronic acid anhydrous DMFs exist exist since differing nations have different regulations, such as zoledronic acid anhydrous USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A zoledronic acid anhydrous DMF submitted to regulatory agencies in the US is known as a USDMF. zoledronic acid anhydrous USDMF includes data on zoledronic acid anhydrous's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The zoledronic acid anhydrous USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of zoledronic acid anhydrous suppliers with USDMF on PharmaCompass.
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