Molecules / Cefaclor

Cefaclor API manufacturers

CAS 53994-73-3 ATC J01DC04 Updated 9 July 2026
12
manufacturers with an active filing 3 of them hold a US DMF or a CEP
41
shortage records on file across 7 countries
300
finished-dose makers across 36 regulators
Showing 12 of 12 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

02

Lupin

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

Holds 2 valid CEPs for cefaclor, filing since 2018. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 30 markets.

US DMF
None on file
CEP
2 valid
Last FDA inspection
2025 · VAI
GMP recognised in
30 markets
How this listing is sourced EDQM certificate database
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03

Zhejiang Dongbang Pharmaceutical

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

Holds one valid CEP for cefaclor, filing since 2024.

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
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04

Mekophar Chemical Pharmaceutical

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for cefaclor. Its GMP is recognised in 2 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
2 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
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05

Imexpharm

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for cefaclor. 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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06

Minh

Vietnam
Makes the API

Registered with DAV (Vietnam) for cefaclor. 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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07

Registered with PMDA (Japan) for cefaclor.

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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08

TV. Pharm

Vietnam
Makes the API

Registered with DAV (Vietnam) for cefaclor.

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
09

Armephaco

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for cefaclor. 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
10

Công ty cổ phần Tập đoàn Merap

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for cefaclor. 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
11

Registered with DAV (Vietnam) for cefaclor. 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

Công ty: CP US Pharma USA

Vietnam
Makes the API

Registered with DAV (Vietnam) for cefaclor.

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

9 more manufacturers hold filings for cefaclor

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

Open the full list with a free account

Contract manufacturers (1)

Yangtze River Pharmaceutical Group China

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

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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