01 1Viatris
01 1ZOFENOPRIL CALCIUM
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22032
Submission : 2008-09-25
Status : Inactive
Type : II
A Zofenopril Calcium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zofenopril Calcium, including repackagers and relabelers. The FDA regulates Zofenopril Calcium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zofenopril Calcium 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 Zofenopril Calcium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Zofenopril Calcium supplier is an individual or a company that provides Zofenopril Calcium active pharmaceutical ingredient (API) or Zofenopril Calcium finished formulations upon request. The Zofenopril Calcium suppliers may include Zofenopril Calcium API manufacturers, exporters, distributors and traders.
click here to find a list of Zofenopril Calcium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Zofenopril Calcium DMF (Drug Master File) is a document detailing the whole manufacturing process of Zofenopril Calcium active pharmaceutical ingredient (API) in detail. Different forms of Zofenopril Calcium DMFs exist exist since differing nations have different regulations, such as Zofenopril Calcium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Zofenopril Calcium DMF submitted to regulatory agencies in the US is known as a USDMF. Zofenopril Calcium USDMF includes data on Zofenopril Calcium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zofenopril Calcium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Zofenopril Calcium suppliers with USDMF on PharmaCompass.
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