Molecules / Gelatin

Gelatin API manufacturers

CAS 9000-70-8 ATC B05AA06 Updated 9 July 2026
15
manufacturers with an active filing 14 of them hold a US DMF or a CEP
6
shortage records on file across 3 countries
70
finished-dose makers across 20 regulators
Showing 15 of 15 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

02

Beijing Cytoniche Biotech

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

Holds one active US DMF for gelatin, filing since 2025. Its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

India Gelatine And Chemicals

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

Holds one valid CEP for gelatin, filing since 2025. 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
08

Rousselot

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

Holds one valid CEP for gelatin, filing since 2026. 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
09

Baotou Dongbao Bio-Tech

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

Holds one valid CEP for gelatin, filing since 2023.

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
10

Chengdu Classic Gelatin

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

Holds one valid CEP for gelatin, filing since 2026.

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
11

Jilin Tianzheng Biotechnology

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

Holds one valid CEP for gelatin, 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
15

Dgfstoessag-Gelitagroup

Germany
Makes the API

Registered with PMDA (Japan) for gelatin.

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

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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