Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
01 1Malladi Drugs & Pharmaceuticals Limited
01 1HEXYLRESORCINOL
01 1India
01 1Active
01 1Blank
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42967
Submission : 2025-12-12
Status : Active
Type : II
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A Caprokol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Caprokol, including repackagers and relabelers. The FDA regulates Caprokol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Caprokol API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Caprokol supplier is an individual or a company that provides Caprokol active pharmaceutical ingredient (API) or Caprokol finished formulations upon request. The Caprokol suppliers may include Caprokol API manufacturers, exporters, distributors and traders.
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A Caprokol DMF (Drug Master File) is a document detailing the whole manufacturing process of Caprokol active pharmaceutical ingredient (API) in detail. Different forms of Caprokol DMFs exist exist since differing nations have different regulations, such as Caprokol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Caprokol DMF submitted to regulatory agencies in the US is known as a USDMF. Caprokol USDMF includes data on Caprokol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Caprokol USDMF is kept confidential to protect the manufacturer’s intellectual property.
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