Molecules / Bupivacaine

Bupivacaine API manufacturers

CAS 38396-39-3 ATC N01BB01 Updated 9 July 2026
15
manufacturers with an active filing 13 of them hold a US DMF or a CEP
$430.00
median export price per kg $376.94 to $566.74 · 7 exporters · 2025
65
shortage records on file across 4 countries
370
finished-dose makers across 47 regulators
Showing 15 of 15 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Excella Gmbh

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

Holds one active US DMF and one valid CEP for bupivacaine, filing since 2007. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 7 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2022 · VAI
GMP recognised in
7 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
02

MSN Laboratories

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

Holds one active US DMF and one valid CEP for bupivacaine, filing since 2020. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 4 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2024 · VAI
GMP recognised in
4 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
03

Moehs

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

Holds one active US DMF and one valid CEP for bupivacaine, filing since 2008. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
05

Jiangsu Hengrui Pharmaceuticals

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

Holds one active US DMF for bupivacaine, filing since 2020. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 8 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
8 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Siegfried

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

Holds 2 active US DMFs and one valid CEP for bupivacaine, filing since 1977. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
07

Dishman Carbogen Amcis

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

Holds 2 active US DMFs for bupivacaine, filing since 2007. Its 2025 FDA inspection closed as NAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Apex Healthcare

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

Holds one active US DMF for bupivacaine, filing since 2025. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 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
View profile
09

Nortec Quimica

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

Holds one active US DMF for bupivacaine, filing since 2018. Its 2023 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Medigraph Pharmaceuticals

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

Holds one valid CEP for bupivacaine, filing since 2020. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
View profile
11

Haichang Biotech

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

Holds one active US DMF for bupivacaine, filing since 2025.

US DMF
1 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
14

Registered with SFDA (Saudi Arabia) for bupivacaine. 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
15

Công ty Cổ phần Dược phẩm CPC1 Hà Nội

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for bupivacaine. 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

12 more manufacturers hold filings for bupivacaine

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

Cambrex Karlskoga ABJiangsu Hengrui PharmaceuticalsSiegfriedDishman Carbogen AmcisApex HealthcareNortec QuimicaMedigraph PharmaceuticalsHaichang BiotechSocieta Italiana Medicinali Scandicci SimsZhejiang Boxiao BiopharmaceuticalDishman Pharmaceuticals and ChemicalsCông ty Cổ phần Dược phẩm CPC1 Hà Nội
Open the full list with a free account

Contract manufacturers (7)

Moehs Ibérica, S.L Spain Ethypharm France Ciron Drugs & Pharmaceuticals India Ray Life Sciences India Vem Ilac Sanayi Ve Ticaret A S Turkey Jiangsu Tianhe Pharmaceutical China Beijing Sunho Pharmaceutical China

Contract manufacturers make to order rather than holding their own filing for this molecule.

Finished-dose makers (67)

Fresenius Kabi Ab Sweden HIKMA ITALIA Italy Aspen Notre Dame De Bondeville France Novocol Pharmaceutical Of Canada Canada Onesource Specialty Pharma India Pfizer Brasil Ltda Brazil Laboratorio Sanderson Chile «B. Braun Medical» Portugal Pt. Novell Pharmaceutical Laboratories Indonesia Sintetica Switzerland Amneal United States Fisiopharma Italy Hospira United States Pacira Pharmaceuticals United States Viatris United States Troikaa Pharmaceuticals India Panpharma Germany Dechra Hospira Healthcare Canada Sandoz Switzerland

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 4 yrs Shortages 65 Recalls 64 Finished dose 67 Contract mfrs 7

By country

India 9 China 6

Sold in these combinations

Epinephrine + Bupivacaine 2 APIs

Fixed-dose combinations containing bupivacaine. Each page leads with the verified API makers of every component.

Export price by year

Year Median Exporters
2025 $430.00 7
2024 $480.00 9
2023 $500.00 8
2022 $537.50 11

US dollars per kilogram, customs export unit values.