Suppliers / Alkaloids

Alkaloids

India 44 employees Updated 9 July 2026

Alkaloids is an API manufacturer based in India. It holds 3 active US drug master files across a filed portfolio of 3 molecules. Its GMP standing is certified by MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 20 September 2024 as VAI. Customs aggregates show $4.0M of exports covering 103 molecules to 35 destinations in 2025.

3
active US DMFs
0
valid CEPs
1
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
3 of 3 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 20 September 2024 VAI US FDA
  • 17 May 2018 VAI US FDA
  • 17 February 2011 VAI US FDA

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

Registered plants

Site FDA FEI
Medchal-Malkajgiri District, India 3004987008

What they file, and where

Molecule Regulators Docs
Scopolamine US FDA 2
Hyoscine Butylbromide SFDA (Saudi Arabia) 1
Methscopolamine Bromide US FDA 1

Also appears on these molecule pages

Scopolamine API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 2 None
MFDS (Korea) None 2
US FDA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $347K 7
2025 Not reported $4.0M 35
2024 Not reported $7.1M 41
2023 Not reported $9.1M 46

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 We do not publish the identity of any buyer.

Questions about Alkaloids

Does Alkaloids hold a US DMF or a CEP?
Alkaloids holds 3 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 Alkaloids FDA-registered?
One site operated by Alkaloids 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 Alkaloids's last inspection go?
The most recent inspection on record closed on 20 September 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does Alkaloids manufacture?
1 registered site is on record, in India (Medchal-malkajgiri District). Every site is listed on this page with the register it came from.
What does Alkaloids make?
3 molecules are on record against Alkaloids, including Scopolamine, Hyoscine Butylbromide and Methscopolamine Bromide. Each links through to that molecule's full manufacturer list.
Which regulators recognise Alkaloids's GMP?
Current GMP certificates are on record from MFDS (Korea) 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 20 September 2024.

Comparable suppliers

Fine Chemicals Corporation (PTY) shares 1 molecule Alchem International shares 1 molecule Phytex Australia shares 1 molecule Phytex Australia Pty 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