Suppliers / Tyche Industries

Tyche Industries

India 2 duplicate records merged Updated 9 July 2026

Tyche Industries is an API manufacturer based in India. It holds 2 active US drug master files and 6 valid CEPs across a filed portfolio of 9 molecules. Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 16 August 2024 as OAI. Customs aggregates show $5.7M of exports covering 91 molecules to 17 destinations in 2025.

2
active US DMFs
6
valid CEPs
2
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

  • 16 August 2024 OAI US FDA
  • 29 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
Hyderabad, India Not on file
Kakinada, India 3004790309

What they file, and where

Molecule Regulators Docs
Sertraline EDQM 2
Azelaic Acid SFDA (Saudi Arabia) 1
Palonosetron US FDA 1
Phenelzine US FDA 1
Racecadotril EDQM 1
Rupatadine EDQM 1
Solifenacin Succinate EDQM 1
Tamsulosin EDQM 1
Tenofovir Disoproxil SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Azelaic Acid API Palonosetron API Racecadotril API Rupatadine API Tamsulosin API Sertraline API Solifenacin API Tenofovir Disoproxil API

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $640K 10
2025 Not reported $5.7M 17
2024 Not reported $4.7M 16
2023 Not reported $5.9M 16

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 We do not publish the identity of any buyer.

Questions about Tyche Industries

Does Tyche Industries hold a US DMF or a CEP?
Tyche Industries holds 2 active US drug master files and 6 valid CEPs. 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 Tyche Industries FDA-registered?
One site operated by Tyche Industries 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 Tyche Industries's last inspection go?
The most recent inspection on record closed on 16 August 2024 as OAI (Official Action Indicated, the worst classification: objectionable conditions were found and regulatory action was warranted). 2 inspections are on file, of which 1 closed as OAI.
Where does Tyche Industries manufacture?
2 registered sites are on record, in India (Hyderabad and Kakinada). Every site is listed on this page with the register it came from.
What does Tyche Industries make?
9 molecules are on record against Tyche Industries, including Sertraline, Azelaic Acid, Palonosetron and Phenelzine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Tyche Industries's GMP?
Current GMP certificates are on record from 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.

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Open risk flags

  • One recent serious compliance event is on record.
  • The most recent inspection outcome was OAI, on 16 August 2024.

Comparable suppliers

MSN Laboratories shares 1 molecule Apitoria Pharma shares 1 molecule Hetero shares 1 molecule Cipla shares 1 molecule Dr Reddy's Laboratories 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