Suppliers / Ion Exchange (India)

Ion Exchange (India)

India Updated 9 July 2026

Ion Exchange (India) is an API manufacturer based in India. It holds 4 active US drug master files across a filed portfolio of 2 molecules. Its GMP standing is certified by CDSCO (India) and US FDA. Its most recent recorded inspection, by US FDA, closed on 5 April 2024 as VAI. Customs aggregates show $7K of exports covering 1 molecule to 1 destination in 2025.

4
active US DMFs
0
valid CEPs
4
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
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 5 April 2024 VAI US FDA
  • 26 June 2015 VAI US FDA

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

Registered plants

Site FDA FEI
strial estate ankleshwar 393 002 bharuch, India Not on file
Gidc, India Not on file
Bharuch, India 3004390840
bharuch, India Not on file

What they file, and where

Molecule Regulators Docs
Calcium US FDA 2
Cholestyramine US FDA 2

Also appears on these molecule pages

Cholestyramine API

Filings and GMP by regulator

Regulator Filings GMP certificates
CDSCO (India) None 3
US FDA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $21K 1
2025 Not reported $7K 1
2024 Not reported $2K 1
2023 Not reported $12K 1

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 We do not publish the identity of any buyer.

Questions about Ion Exchange (India)

Does Ion Exchange (India) hold a US DMF or a CEP?
Ion Exchange (India) holds 4 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 Ion Exchange (India) FDA-registered?
One site operated by Ion Exchange (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 Ion Exchange (India)'s last inspection go?
The most recent inspection on record closed on 5 April 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does Ion Exchange (India) manufacture?
4 registered sites are on record, in India (Strial Estate Ankleshwar 393 002 Bharuch, Gidc and Bharuch among others). Every site is listed on this page with the register it came from.
What does Ion Exchange (India) make?
2 molecules are on record against Ion Exchange (India), including Calcium and Cholestyramine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Ion Exchange (India)'s GMP?
Current GMP certificates are on record from CDSCO (India) and US FDA. 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 5 April 2024.

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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