Suppliers / Covalent Laboratories

Covalent Laboratories

India 110 employees 2 duplicate records merged Updated 9 July 2026

Covalent Laboratories is an API manufacturer based in India. It holds 7 active US drug master files and 2 valid CEPs across a filed portfolio of 8 molecules. Its GMP standing is certified by MFDS (Korea), EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 25 April 2025 as NAI. Customs aggregates show $75.7M of exports covering 590 molecules to 32 destinations in 2025.

7
active US DMFs
2
valid CEPs
3
registered plants 1 with an FDA FEI number
1
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
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

  • 25 April 2025 NAI US FDA
  • 23 November 2018 NAI US FDA
  • 10 April 2015 NAI US FDA

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

Registered plants

Site FDA FEI
Hyderabad, India Not on file
Sangareddy, India Not on file
Sangareddy District, India 3004590215

What they file, and where

Molecule Regulators Docs
Cefdinir SFDA (Saudi Arabia), US FDA 5
Cefixime EDQM, SFDA (Saudi Arabia), US FDA 3
Cefuroxime US FDA 2
Cefpodoxime US FDA 1
Cefpodoxime Proxetil SFDA (Saudi Arabia) 1
Cefprozil US FDA 1
Cefuroxime Axetil EDQM 1
Cepodoxime Proxelil SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Cefdinir API Cefixime API Cefpodoxime API Cefprozil API Cefuroxime API Cefuroxime Axetil API

Filings and GMP by regulator

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

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $11.8M 27
2025 Not reported $75.7M 32
2024 Not reported $87.8M 36
2023 Not reported $96.1M 33

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 We do not publish the identity of any buyer.

Questions about Covalent Laboratories

Does Covalent Laboratories hold a US DMF or a CEP?
Covalent Laboratories holds 7 active US drug master files and 2 valid CEPs. 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 Covalent Laboratories FDA-registered?
One site operated by Covalent Laboratories 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 Covalent Laboratories's last inspection go?
The most recent inspection on record closed on 25 April 2025 as NAI (No Action Indicated: nothing objectionable was found). 3 inspections are on file.
Where does Covalent Laboratories manufacture?
3 registered sites are on record, in India (Hyderabad, Sangareddy and Sangareddy District). Every site is listed on this page with the register it came from.
What does Covalent Laboratories make?
8 molecules are on record against Covalent Laboratories, including Cefdinir, Cefixime, Cefuroxime and Cefpodoxime. Each links through to that molecule's full manufacturer list.
Which regulators recognise Covalent Laboratories's GMP?
Current GMP certificates are on record from MFDS (Korea), EMA 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 NAI, on 25 April 2025.

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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