01 1GLAND PHARMA LIMITED
02 1Global Calcium
03 1Harman Finochem
01 1CUPRIC SULFATE
02 2CUPRIC SULFATE USP
01 3India
01 3Active
01 3Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-03-31
Pay. Date : 2023-02-09
DMF Number : 37879
Submission : 2022-12-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-06
Pay. Date : 2023-09-27
DMF Number : 37651
Submission : 2023-01-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-01-19
Pay. Date : 2022-12-07
DMF Number : 37484
Submission : 2022-09-30
Status : Active
Type : II
A Copper Sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Copper Sulfate, including repackagers and relabelers. The FDA regulates Copper Sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Copper Sulfate 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 Copper Sulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Copper Sulfate supplier is an individual or a company that provides Copper Sulfate active pharmaceutical ingredient (API) or Copper Sulfate finished formulations upon request. The Copper Sulfate suppliers may include Copper Sulfate API manufacturers, exporters, distributors and traders.
click here to find a list of Copper Sulfate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Copper Sulfate DMF (Drug Master File) is a document detailing the whole manufacturing process of Copper Sulfate active pharmaceutical ingredient (API) in detail. Different forms of Copper Sulfate DMFs exist exist since differing nations have different regulations, such as Copper Sulfate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Copper Sulfate DMF submitted to regulatory agencies in the US is known as a USDMF. Copper Sulfate USDMF includes data on Copper Sulfate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Copper Sulfate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Copper Sulfate suppliers with USDMF on PharmaCompass.
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