Suppliers / Nakoda Chemicals

Nakoda Chemicals

India 99 employees Updated 9 July 2026

Nakoda Chemicals is an API manufacturer based in India. It holds 2 active US drug master files across a filed portfolio of 2 molecules. Its GMP standing is certified by US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 29 March 2024 as NAI. Customs aggregates show $4.5M of exports covering 123 molecules to 35 destinations in 2025.

2
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
2 of 2 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 29 March 2024 NAI US FDA
  • 22 January 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
Hyderabad, India 3006590829

What they file, and where

Molecule Regulators Docs
Acetazolamide SFDA (Saudi Arabia), US FDA 2
Famotidine SFDA (Saudi Arabia), US FDA 2

Also appears on these molecule pages

Acetazolamide API Famotidine API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1
EMA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $243K 10
2025 Not reported $4.5M 35
2024 Not reported $19.9M 31
2023 Not reported $4.4M 31

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 We do not publish the identity of any buyer.

Questions about Nakoda Chemicals

Does Nakoda Chemicals hold a US DMF or a CEP?
Nakoda Chemicals holds 2 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 Nakoda Chemicals FDA-registered?
One site operated by Nakoda Chemicals 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 Nakoda Chemicals's last inspection go?
The most recent inspection on record closed on 29 March 2024 as NAI (No Action Indicated: nothing objectionable was found). 2 inspections are on file.
Where does Nakoda Chemicals manufacture?
1 registered site is on record, in India (Hyderabad). Every site is listed on this page with the register it came from.
What does Nakoda Chemicals make?
2 molecules are on record against Nakoda Chemicals, including Acetazolamide and Famotidine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Nakoda Chemicals's GMP?
Current GMP certificates are on record from US FDA and EMA. 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.

Comparing suppliers?

Choose your molecules and target markets. Nakoda Chemicals comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

  • The most recent inspection outcome was NAI, on 29 March 2024.

Comparable suppliers

Apitoria Pharma shares 1 molecule Hetero shares 1 molecule Dr Reddy's Laboratories shares 1 molecule Alembic Pharmaceuticals shares 1 molecule Zydus Lifesciences shares 1 molecule

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
EudraGMDP and national regulators
GMP certificates
Customs aggregates
Export values, molecule and destination counts