Molecules / Lidocaine

Lidocaine API manufacturers

CAS 137-58-6 ATC C01BB01 Updated 9 July 2026
20
manufacturers with an active filing 12 of them hold a US DMF or a CEP
$23.00
median export price per kg $15.00 to $34.00 · 86 exporters · 2025
167
shortage records on file across 10 countries
1,955
finished-dose makers across 54 regulators
Showing 20 of 20 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

06

W. R. Grace & Co.-Conn

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

Holds 2 active US DMFs for lidocaine, filing since 1981. Its 2026 FDA inspection closed as NAI, and its GMP is recognised in 2 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2026 · NAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
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07

Viwit Pharmaceutical

China
Makes the API

Holds one valid CEP for lidocaine, filing since 2024. Its 2024 FDA inspection closed as NAI.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
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08

Apex Healthcare

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

Holds 2 active US DMFs for lidocaine, filing since 2019. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
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10

Gufic Biosciences

India
Makes the APIFinished dose

Registered with SFDA (Saudi Arabia) for lidocaine. Its GMP is recognised in 9 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
9 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
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11

Chemino Pharma

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

Holds one valid CEP for lidocaine, filing since 2025.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
View profile
14

Roquette Frères

France
Makes the API

Registered with SFDA (Saudi Arabia) for lidocaine. Its 2020 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
2020 · VAI
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
15

Registered with SFDA (Saudi Arabia) for lidocaine.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
16

Công ty cổ phần Dược phẩm VCP

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for lidocaine. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
17

Kairav Chemicals

India
Makes the API

Registered with SFDA (Saudi Arabia) for lidocaine.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile

Registered with SFDA (Saudi Arabia) for lidocaine.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
19

Công ty Cổ phần Dược phẩm CPC1 Hà Nội

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for lidocaine. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
20

Registered with DAV (Vietnam) for lidocaine. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile

Contract manufacturers (8)

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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By country

Export price by year

Year Median Exporters
2026 YTD $17.42 25
2025 $23.00 86
2024 $21.00 111
2023 $20.99 70

US dollars per kilogram, customs export unit values.