Suppliers / CTX Lifesciences

CTX Lifesciences

India 421 employees reconciled across 5 public records · 2 entities Updated 9 July 2026

CTX Lifesciences is an API manufacturer based in India. It holds 27 active US drug master files and 21 valid CEPs across a filed portfolio of 29 molecules. Its GMP standing is certified by CDSCO (India), MFDS (Korea) and EMA. Its most recent recorded inspection, by US FDA, closed on 2 September 2022 as VAI. Customs aggregates show $13.4M of exports covering 545 molecules to 56 destinations in 2025.

27
active US DMFs
21
valid CEPs
5
registered plants 1 with an FDA FEI number
7
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 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

  • 2 September 2022 VAI US FDA
  • 30 January 2018 VAI US FDA
  • 19 February 2016 OAI US FDA
  • 30 December 2012 VAI US FDA
  • 6 November 2009 VAI US FDA

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

Registered plants

Site FDA FEI
Surat, India Not on file
Surat, India Not on file
Surat, India 3006254924
Surat, India Not on file
Surat, India Not on file

What they file, and where

Molecule Regulators Docs
Metoprolol EDQM, SFDA (Saudi Arabia), US FDA 5
Hydrochlorothiazide EDQM, SFDA (Saudi Arabia), US FDA 4
Acetazolamide EDQM, SFDA (Saudi Arabia), US FDA 3
Lamotrigine EDQM, SFDA (Saudi Arabia), US FDA 3
Xylometazoline EDQM, SFDA (Saudi Arabia), US FDA 3
Amiodarone EDQM, US FDA 2
Carbamazepine EDQM, US FDA 2
Carvedilol EDQM, US FDA 2
Chlorthalidone EDQM, US FDA 2
Deferasirox EDQM, US FDA 2
Show all 29 molecules on file
Irbesartan EDQM, US FDA 2
Mesalazine EDQM, US FDA 2
Oxcarbazepine EDQM, US FDA 2
Oxymetazoline EDQM, US FDA 2
Pregabalin EDQM, US FDA 2
Rosuvastatin EDQM, US FDA 2
Rosuvastatin Calcium EDQM 2
Ticagrelor EDQM, US FDA 2
Alogliptin US FDA 1
Amisulpride EDQM 1
Apixaban US FDA 1
Chlorothiazide US FDA 1
Empagliflozin US FDA 1
Eslicarbazepine Acetate US FDA 1
Linagliptin US FDA 1
Metoprolol Tartrate EDQM 1
Olmesartan US FDA 1
Saxagliptin US FDA 1
Telmisartan US FDA 1

Also appears on these molecule pages

Show 21 more molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 7 None
CDSCO (India) None 4
MFDS (Korea) None 2
EMA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $4.2M 45
2025 Not reported $13.4M 56
2024 Not reported $1.2M 11
2023 Not reported $1.0M 9

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

Questions about CTX Lifesciences

Does CTX Lifesciences hold a US DMF or a CEP?
CTX Lifesciences holds 27 active US drug master files and 21 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 CTX Lifesciences FDA-registered?
One site operated by CTX Lifesciences 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 CTX Lifesciences's last inspection go?
The most recent inspection on record closed on 2 September 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file, of which 1 closed as OAI.
Where does CTX Lifesciences manufacture?
5 registered sites are on record, in India (Surat among others). Every site is listed on this page with the register it came from.
What does CTX Lifesciences make?
29 molecules are on record against CTX Lifesciences, including Metoprolol, Hydrochlorothiazide, Acetazolamide and Lamotrigine. Each links through to that molecule's full manufacturer list.
Which regulators recognise CTX Lifesciences's GMP?
Current GMP certificates are on record from CDSCO (India), MFDS (Korea) 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.

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Open risk flags

  • The most recent inspection outcome was VAI, on 2 September 2022.

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