Molecules / Clavulanic Acid

Clavulanic Acid API manufacturers

CAS 58001-44-8 Updated 9 July 2026
5
manufacturers with an active filing 5 of them hold a US DMF or a CEP
$144.50
median export price per kg $101.76 to $153.00 · 8 exporters · 2025
5
shortage records on file across 2 countries
487
finished-dose makers across 25 regulators
Showing 5 of 5 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Shandong New Time Pharmaceutical

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 3 active US DMFs for clavulanic acid, filing since 2012. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

US DMF
3 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
6 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
02

Lek Pharmaceuticals D.D

Slovenia
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 4 active US DMFs for clavulanic acid, filing since 2000. Its GMP is recognised in 13 markets.

US DMF
4 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
13 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Sinopharm Weiqida Pharmaceutical

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 3 active US DMFs for clavulanic acid, filing since 2014. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 5 markets.

US DMF
3 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
5 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

CKD Bio

South Korea
Makes the API

Holds 6 active US DMFs for clavulanic acid, filing since 2003. Its 2025 FDA inspection closed as VAI.

US DMF
6 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Fermic Sa De Cv

Mexico
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for clavulanic acid, filing since 2002.

US DMF
2 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile

2 more manufacturers hold filings for clavulanic acid

The names are listed below. The filings, inspection history and GMP certificates behind each one are available with a free account.

CKD BioFermic Sa De Cv
Open the full list with a free account

Finished-dose makers (42)

Sandoz Switzerland HIKMA ITALIA Italy Cipla India Micro Labs India Viatris United States Apotex Canada Zentiva, k.s Czech Republic Fresenius Kabi Ab Sweden Gsk Vaccines United Kingdom Teva Israel USAntibiotics United States Eurofarma Laboratorios Brazil Zydus Lifesciences India GlaxoSmithKline United States Fidia Farmaceutici Italy Ipca Laboratories India JNTL Consumer Health (France) S.A.S France Jamp Pharma Canada Yung Shin Pharmaceutical Ind Taiwan Towa Pharmaceutical Europe, S.L Spain

How this list is built

The order is set by active filings weighted by regulator, inspection outcomes and their recency, breadth of GMP recognition, and evidence of real exports, less any open risk flags. Every factor appears on the card it produced. Read the full method.

Active US DMFs
FDA, List of Drug Master Files
Valid CEPs
EDQM certificate database
Inspection outcomes
FDA inspection classifications
GMP certificates
EudraGMDP and national regulators
Price band
Customs export unit values for 2025. These are export values rather than contract prices for regulated-market grade material, which are higher.

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Also on this molecule

Price history 3 yrs Shortages 5 Recalls 10 Finished dose 42 Contract mfrs 0

Export price by year

Year Median Exporters
2025 $144.50 8
2024 $154.00 6
2023 $155.00 6

US dollars per kilogram, customs export unit values.