Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
KEY PRODUCTS
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01 1Malladi Drugs & Pharmaceuticals Limited
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01 1DOXYLAMINE SUCCINATE
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01 1India
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01 1Active
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01 1Complete
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
GDUFA
DMF Review : Complete
Rev. Date : 2024-07-03
Pay. Date : 2024-06-14
DMF Number : 38487
Submission : 2023-12-26
Status : Active
Type : II
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Malladi Drugs And Pharmaceuticals Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
They are recognized for Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
One of their notable products is DOXYLAMINE SUCCINATE, with a corresponding US DMF Number 38487.
Remarkably, this DMF maintains an Active status since its submission on December 26, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 03, 2024, and payment made on June 14, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II