Suppliers / Chromo Laboratories India

Chromo Laboratories India

India Updated 9 July 2026

Chromo Laboratories India is an API manufacturer based in India. It holds 88 active US drug master files. Its most recent recorded inspection, by US FDA, closed on 7 February 2018 as VAI. Customs aggregates show $6.2M of exports covering 87 molecules to 20 destinations in 2025.

88
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
1
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
2 of 2 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 7 February 2018 VAI US FDA
  • 22 January 2016 NAI US FDA

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

Registered plants

Site FDA FEI
Sangareddy, India 3008771562

What they file, and where

Molecule Regulators Docs
Omeprazole US FDA 4
Rosuvastatin US FDA 4
Zafirlukast US FDA 4
Ziprasidone US FDA 4
Moxifloxacin SFDA (Saudi Arabia), US FDA 3
Abacavir US FDA 2
Aripiprazole US FDA 2
Armodafinil US FDA 2
Atazanavir US FDA 2
Atorvastatin US FDA 2
Show all 30 molecules on file
Azilsartan Medoxomil US FDA 2
Candesartan US FDA 2
Chlorthalidone US FDA 2
Darunavir US FDA 2
Dexlansoprazole US FDA 2
Dolutegravir US FDA 2
Esomeprazole US FDA 2
Ketorolac US FDA 2
Lacosamide US FDA 2
Lansoprazole US FDA 2
Levocetirizine US FDA 2
Levofloxacin US FDA 2
Linezolid US FDA 2
Modafinil US FDA 2
Olanzapine US FDA 2
Olmesartan US FDA 2
Oseltamivir US FDA 2
Posaconazole US FDA 2
Praziquantel US FDA 2
Pregabalin US FDA 2

Also appears on these molecule pages

Abacavir API Armodafinil API Atazanavir API Azilsartan Medoxomil API Candesartan API Chlorthalidone API Darunavir API Dexlansoprazole API Dolutegravir API Ketorolac Tromethamine API Lacosamide API Lansoprazole API
Show 23 more molecule pages
Levocetirizine API Linezolid API Modafinil API Moxifloxacin API Posaconazole API Praziquantel API Repaglinide API Ritonavir API Sumatriptan API Tenofovir Disoproxil API Terbinafine API Vardenafil API Ziprasidone API Atorvastatin API Rosuvastatin API Omeprazole API Esomeprazole API Levofloxacin API Pregabalin API Olmesartan API Olanzapine API Aripiprazole API Oseltamivir API

Filings and GMP by regulator

Regulator Filings GMP certificates
CDSCO (India) 1 None

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $1.6M 9
2025 Not reported $6.2M 20
2024 Not reported $6.9M 21
2023 Not reported $4.0M 22

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

Questions about Chromo Laboratories India

Does Chromo Laboratories India hold a US DMF or a CEP?
Chromo Laboratories India holds 88 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 Chromo Laboratories India FDA-registered?
One site operated by Chromo Laboratories India carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Chromo Laboratories India's last inspection go?
The most recent inspection on record closed on 7 February 2018 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does Chromo Laboratories India manufacture?
1 registered site is on record, in India (Sangareddy). Every site is listed on this page with the register it came from.
What does Chromo Laboratories India make?
30 molecules are on record against Chromo Laboratories India, including Omeprazole, Rosuvastatin, Zafirlukast and Ziprasidone. Each links through to that molecule's full manufacturer list.
Where does Chromo Laboratories India file?
Filings are on record with CDSCO (India), 1 in total.

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

  • The most recent inspection outcome was VAI, on 7 February 2018.

Comparable suppliers

Apitoria Pharma shares 15 molecules Dr Reddy's Laboratories shares 14 molecules Matrix Pharmacorp shares 13 molecules Hetero shares 11 molecules Macleods Pharmaceuticals shares 11 molecules

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

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