Suppliers / Apex Healthcare

Apex Healthcare

India 74 employees 2 duplicate records merged Updated 9 July 2026

Apex Healthcare is an API manufacturer based in India. It holds 10 active US drug master files across a filed portfolio of 9 molecules. Its GMP standing is certified by CDSCO (India) and US FDA. Its most recent recorded inspection, by US FDA, closed on 15 June 2023 as VAI. Customs aggregates show $8.1M of exports covering 305 molecules to 46 destinations in 2025.

10
active US DMFs
0
valid CEPs
3
registered plants 1 with an FDA FEI number
2
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 15 June 2023 VAI US FDA

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

Registered plants

Site FDA FEI
Ankleshwar, India 3006509185
bharuch 393 002, India Not on file
Bharuch, India Not on file

What they file, and where

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 2 None
CDSCO (India) None 3
US FDA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $931K 20
2025 Not reported $8.1M 46
2024 Not reported $6.2M 41
2023 Not reported $4.5M 33

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 We do not publish the identity of any buyer.

Questions about Apex Healthcare

Does Apex Healthcare hold a US DMF or a CEP?
Apex Healthcare holds 10 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 Apex Healthcare FDA-registered?
One site operated by Apex Healthcare 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 Apex Healthcare's last inspection go?
The most recent inspection on record closed on 15 June 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 1 inspection is on file.
Where does Apex Healthcare manufacture?
3 registered sites are on record, in India (Ankleshwar, Bharuch 393 002 and Bharuch). Every site is listed on this page with the register it came from.
What does Apex Healthcare make?
9 molecules are on record against Apex Healthcare, including Lidocaine, Acyclovir, Benzocaine and Bisacodyl. Each links through to that molecule's full manufacturer list.
Which regulators recognise Apex Healthcare'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

  • 17 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 15 June 2023.

Comparable suppliers

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