Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
01 4Malladi Drugs & Pharmaceuticals Limited
02 1Alkem Laboratories
03 2China National Pharmaceutical Foreign Trade Co
04 1Curia
05 1ERREDUE S.P.A. IT 24040 Isso
06 1Ipca Laboratories
07 1Siegfried AG
08 1Takasago International
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 : 19416
Submission : 2006-05-09
Status :
Type : II
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 : 37808
Submission : 2023-04-27
Status :
Type : II
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 : 33270
Submission : 2018-10-26
Status :
Type : II
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 : 23016
Submission : 2009-08-07
Status :
Type : II
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A Ritalinic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ritalinic Acid, including repackagers and relabelers. The FDA regulates Ritalinic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ritalinic Acid 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 Ritalinic Acid supplier is an individual or a company that provides Ritalinic Acid active pharmaceutical ingredient (API) or Ritalinic Acid finished formulations upon request. The Ritalinic Acid suppliers may include Ritalinic Acid API manufacturers, exporters, distributors and traders.
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A Ritalinic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Ritalinic Acid active pharmaceutical ingredient (API) in detail. Different forms of Ritalinic Acid DMFs exist exist since differing nations have different regulations, such as Ritalinic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ritalinic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Ritalinic Acid USDMF includes data on Ritalinic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ritalinic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
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