Suppliers / Malladi Drugs & Pharmaceuticals

Malladi Drugs & Pharmaceuticals

India 740 employees Updated 9 July 2026

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.

19
active US DMFs
0
valid CEPs
4
registered plants 3 with an FDA FEI number
2
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
3 of 3 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 2 May 2025 VAI US FDA
  • 11 November 2022 VAI US FDA
  • 31 January 2020 VAI US FDA
  • 2 August 2019 NAI US FDA
  • 9 October 2018 VAI US FDA
  • 8 September 2017 OAI US FDA
  • 4 August 2017 VAI US FDA
  • 18 November 2016 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Vellore, India 3005115135
Ranipet, India 3002780785
Chittoor, India 3004896422
Ranipet, India Not on file

What they file, and where

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
Show all 18 molecules on file
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

Show 2 more molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
CDSCO (India) 1 2
MINSA (CR) 1 None
US FDA None 1

Questions about Malladi Drugs & Pharmaceuticals

Does Malladi Drugs & Pharmaceuticals hold a US DMF or a CEP?
Malladi Drugs & Pharmaceuticals holds 19 active US drug master files. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Malladi Drugs & Pharmaceuticals FDA-registered?
3 sites operated by Malladi Drugs & Pharmaceuticals carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Malladi Drugs & Pharmaceuticals's last inspection go?
The most recent inspection on record closed on 2 May 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file, of which 1 closed as OAI.
Where does Malladi Drugs & Pharmaceuticals manufacture?
4 registered sites are on record, in India (Vellore, Ranipet and Chittoor among others). Every site is listed on this page with the register it came from.
What does Malladi Drugs & Pharmaceuticals make?
18 molecules are on record against Malladi Drugs & Pharmaceuticals, including Phenylephrine, Pseudoephedrine, Alprazolam and Amylmetacresol. Each links through to that molecule's full manufacturer list.
Which regulators recognise Malladi Drugs & Pharmaceuticals's GMP?
Current GMP certificates are on record from CDSCO (India) and US FDA. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

  • 1 active litigation matter is on record.
  • The most recent inspection outcome was VAI, on 2 May 2025.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates