Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
01 1Malladi Drugs & Pharmaceuticals Limited
01 1PHENYLEPHRINE BITARTRATE
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 : 20475
Submission : 2007-04-23
Status : Active
Type : II
A Phenylephrine Bitartrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Phenylephrine Bitartrate, including repackagers and relabelers. The FDA regulates Phenylephrine Bitartrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Phenylephrine Bitartrate 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 Phenylephrine Bitartrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Phenylephrine Bitartrate supplier is an individual or a company that provides Phenylephrine Bitartrate active pharmaceutical ingredient (API) or Phenylephrine Bitartrate finished formulations upon request. The Phenylephrine Bitartrate suppliers may include Phenylephrine Bitartrate API manufacturers, exporters, distributors and traders.
click here to find a list of Phenylephrine Bitartrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Phenylephrine Bitartrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Phenylephrine Bitartrate active pharmaceutical ingredient (API) in detail. Different forms of Phenylephrine Bitartrate DMFs exist exist since differing nations have different regulations, such as Phenylephrine Bitartrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Phenylephrine Bitartrate DMF submitted to regulatory agencies in the US is known as a USDMF. Phenylephrine Bitartrate USDMF includes data on Phenylephrine Bitartrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Phenylephrine Bitartrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Phenylephrine Bitartrate suppliers with USDMF on PharmaCompass.
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