Suppliers / R.L.Fine Chem

R.L.Fine Chem

India 561 employees 2 duplicate records merged Updated 9 July 2026

R.L.Fine Chem is an API manufacturer based in India. It holds 14 active US drug master files across a filed portfolio of 13 molecules. Its GMP standing is certified by CDSCO (India). Its most recent recorded inspection, by US FDA, closed on 14 April 2023 as VAI. Customs aggregates show $10.7M of exports covering 423 molecules to 64 destinations in 2025.

14
active US DMFs
0
valid CEPs
6
registered plants 3 with an FDA FEI number
2
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
3 of 3 confirmed
Inspections
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 14 April 2023 VAI US FDA
  • 22 February 2019 VAI US FDA
  • 17 July 2015 VAI US FDA
  • 19 July 2013 VAI US FDA
  • 24 March 2011 VAI US FDA

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

Registered plants

Site FDA FEI
Bangalore, India 3005560263
chickkaballapur, India Not on file
bengaluru 560 064, India Not on file
Bengaluru, India Not on file
Hindupur, India 3039941881
Bengaluru, India 3013140488

What they file, and where

Molecule Regulators Docs
Orphenadrine US FDA 2
Buspirone US FDA 1
Carbinoxamine US FDA 1
Chlordiazepoxide US FDA 1
Clonazepam US FDA 1
Clozapine US FDA 1
Diazepam US FDA 1
Doxepin US FDA 1
Eszopiclone US FDA 1
Meclizine US FDA 1
Show all 13 molecules on file
Pramocaine US FDA 1
Sertraline US FDA 1
Temazepam US FDA 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 2 None
CDSCO (India) None 4

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $8.3M 41
2025 Not reported $10.7M 64

Export figures are customs aggregates. We do not publish the identity of any buyer.

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Open risk flags

  • The most recent inspection outcome was VAI, on 14 April 2023.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates
Customs aggregates
Export values, molecule and destination counts