Suppliers / Biological E

Biological E

India 243 employees 3 duplicate records merged Updated 9 July 2026

Biological E is a finished-dose manufacturer based in India. It appears in 62 regulatory filings across 12 regulators, without an active US DMF or CEP on file. Its filings concentrate with EDE (AE), MCAZ (ZW) and NMRC (NA). Its GMP standing is certified by ANVISA (Brazil), EMA and FDA (GH), among 7 authorities. Its most recent recorded inspection, by US FDA, closed on 12 November 2024 as VAI. Customs aggregates show $350.7M of exports covering 1,175 molecules to 112 destinations in 2025.

0
active US DMFs
0
valid CEPs
5
registered plants 2 with an FDA FEI number
62
filings across 12 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
4 of 4 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

  • 12 November 2024 VAI US FDA
  • 26 April 2024 VAI US FDA
  • 2 August 2019 VAI US FDA
  • 6 March 2019 NAI US FDA

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

Registered plants

Site FDA FEI
Medchal, United Arab Emirates Not on file
TELANGANA, India Not on file
Medchal, India 3008377265
Medchal, India 3009522832
Medchal Malkajgiri, India Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
EDE (AE) 29 None
MCAZ (ZW) 8 None
NMRC (NA) 3 None
NAFDAC (NG) 3 1
JFDA (JO) 3 None
COFEPRIS (MX) 3 None
ANVISA (Brazil) None 4
EMA None 2
FDA (GH) None 2
CDSCO (India) None 2
US FDA None 1
MHRA (UK) None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $32.1M 54
2025 Not reported $350.7M 112
2024 Not reported $224.8M 120
2023 Not reported $181.9M 116

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 We do not publish the identity of any buyer.

Questions about Biological E

Does Biological E hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Biological E. It does have 62 filings with 12 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Biological E FDA-registered?
2 sites operated by Biological E carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Biological E's last inspection go?
The most recent inspection on record closed on 12 November 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Biological E manufacture?
5 registered sites are on record, in United Arab Emirates and India (Medchal, Telangana and Medchal Malkajgiri among others). Every site is listed on this page with the register it came from.
Which regulators recognise Biological E's GMP?
Current GMP certificates are on record from ANVISA (Brazil), EMA, FDA (GH), CDSCO (India), US FDA and 2 more. 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 12 November 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