Molecules / Nefopam

Nefopam API manufacturers

CAS 13669-70-0 ATC N02BG06 Updated 9 July 2026
5
manufacturers with an active filing 3 of them hold a US DMF or a CEP
130
finished-dose makers across 22 regulators
Showing 5 of 5 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

PMC Isochem

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

Holds 3 active US DMFs for nefopam, filing since 2008. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
3 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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02

Arene Life Sciences

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

Holds 2 active US DMFs for nefopam, filing since 2025. Its 2024 FDA inspection closed as VAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
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03

Anhui Wanhe Pharmaceutical

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

Holds one active US DMF for nefopam, 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
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04

Pharmasynthese

France
Makes the API

Registered with SFDA (Saudi Arabia) for nefopam.

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
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05

Registered with DAV (Vietnam) for nefopam. 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
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2 more manufacturers hold filings for nefopam

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

PharmasyntheseCông ty Cổ phần Dược phẩm Khánh Hòa (Khapharco)
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Finished-dose makers (25)

Delpharm Tours France Biocodex France Glenmark Pharmaceuticals s.r.o Czech Republic Viatris United States Farmak Czech Republic Medreich India Altan Pharmaceuticals Spain Dawa Kenya Medochemie Cyprus Medical Union Pharmaceuticals-MUP-Official Egypt Công ty Cổ phần Dược phẩm OPV Vietnam Armephaco Vietnam Công Ty TNHH Dược Phẩm Hạnh Thái Vietnam Công ty Cổ phần Dược phẩm Tipharco Vietnam Công ty TNHH Dược phẩm BV Pharma Vietnam Công ty cổ phần dược Danapha Vietnam Công ty cổ phần dược phẩm TW 25 Vietnam Công ty cổ phần dược phẩm Vĩnh Phúc (Vinphaco) Vietnam Công ty cổ phần dược Đồng Nai (Donaipharm) Vietnam Công ty cổ phần xuất nhập khẩu y tế Domesco Vietnam

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

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Also on this molecule

Finished dose 25 Contract mfrs 0