Suppliers / Alkaloids Bioactives

Alkaloids Bioactives

India 9 employees Updated 9 July 2026

Alkaloids Bioactives is an API manufacturer based in India. It holds one active US drug master file. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 23 February 2024 as NAI. Customs aggregates show $2.8M of exports covering 50 molecules to 21 destinations in 2025.

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

Inspection history

  • 23 February 2024 NAI US FDA
  • 9 June 2016 NAI US FDA
  • 25 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, India 3004443761

What they file, and where

Molecule Regulators Docs
Colchicine US FDA 1

Also appears on these molecule pages

Colchicine API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $745K 12
2025 Not reported $2.8M 21

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 We do not publish the identity of any buyer.

Questions about Alkaloids Bioactives

Does Alkaloids Bioactives hold a US DMF or a CEP?
Alkaloids Bioactives holds 1 active US drug master file. 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 Bioactives FDA-registered?
One site operated by Alkaloids Bioactives 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 Bioactives's last inspection go?
The most recent inspection on record closed on 23 February 2024 as NAI (No Action Indicated: nothing objectionable was found). 3 inspections are on file.
Where does Alkaloids Bioactives manufacture?
1 registered site is on record, in India (Medchal-malkajgiri). Every site is listed on this page with the register it came from.
What does Alkaloids Bioactives make?
1 molecule is on record against Alkaloids Bioactives, including Colchicine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Alkaloids Bioactives's GMP?
Current GMP certificates are on record from 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 NAI, on 23 February 2024.

Comparable suppliers

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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