Malladi Drugs & Pharmaceuticals is an API manufacturer based in India. It holds 19 active US drug master files across a filed portfolio of 18 molecules. Its filings concentrate with CDSCO (India) and MINSA (CR). Its GMP standing is certified by CDSCO (India) and US FDA. Its most recent recorded inspection, by US FDA, closed on 2 May 2025 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Vellore, India | 3005115135 |
| Ranipet, India | 3002780785 |
| Chittoor, India | 3004896422 |
| Ranipet, India | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Phenylephrine | SFDA (Saudi Arabia), US FDA | 4 |
| Pseudoephedrine | SFDA (Saudi Arabia), US FDA | 4 |
| Alprazolam | US FDA | 1 |
| Amylmetacresol | US FDA | 1 |
| Aspartic Acid | US FDA | 1 |
| Bilastine | US FDA | 1 |
| Bosentan | SFDA (Saudi Arabia) | 1 |
| Chlorpheniramine | US FDA | 1 |
| Dextromethorphan | US FDA | 1 |
| Dichlorobenzyl Alcohol | US FDA | 1 |
| Doxylamine | US FDA | 1 |
| Ephedrine | US FDA | 1 |
| Hexylresorcinol | US FDA | 1 |
| Lorazepam | US FDA | 1 |
| Metaraminol | US FDA | 1 |
| Phentermine | US FDA | 1 |
| Tranexamic Acid | US FDA | 1 |
| Triprolidine | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| CDSCO (India) | 1 | 2 |
| MINSA (CR) | 1 | None |
| US FDA | None | 1 |
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