Molecules / Somatostatin

Somatostatin API manufacturers

CAS 38916-34-6 ATC H01CB01 Updated 9 July 2026
5
manufacturers with an active filing 5 of them hold a US DMF or a CEP
2
shortage records on file across 2 countries
70
finished-dose makers across 21 regulators
Showing 5 of 5 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Hybio Pharmaceutical

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

Holds one valid CEP for somatostatin, filing since 2024. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 3 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
3 markets
How this listing is sourced EDQM certificate database
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02

Piramal Pharma

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

Holds one valid CEP for somatostatin, filing since 2022. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 10 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
10 markets
How this listing is sourced EDQM certificate database
View profile
03
Credentials confirmed against the regulator files on 25 July 2026

Holds one valid CEP for somatostatin, filing since 2022. Its 2025 FDA inspection closed as VAI.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
View profile
04

Bachem

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

Holds one valid CEP for somatostatin, filing since 2021. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2024 · VAI
GMP recognised in
2 markets
How this listing is sourced EDQM certificate database
View profile
05
Credentials confirmed against the regulator files on 25 July 2026

Holds one valid CEP for somatostatin, filing since 2021. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2024 · VAI
GMP recognised in
2 markets
How this listing is sourced EDQM certificate database
View profile

2 more manufacturers hold filings for somatostatin

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

BachemHainan Shuangcheng Pharmaceuticals
Open the full list with a free account

Contract manufacturers (7)

Bachem Switzerland Zhejiang Peptites Biotech China Shenzhen Jymed Technology China Eumedica Pharmaceuticals Belgium Anfarm Hellas Greece Gp Pharm Spain PolyPeptide Sweden

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

Finished-dose makers (11)

Ucb Pharma Belgium HIKMA ITALIA Italy Viatris United States Gp Pharm Spain Laboratorios Normon Spain Eumedica Pharmaceuticals Belgium Ems S/A Brazil Công Ty TNHH Dược Phẩm Hạnh Thái Vietnam Công ty Cổ phần Nam Dược Vietnam Novell Pharmaceutical Laboratories Indonesia Guna Italy

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

Shortages 2 Finished dose 11 Contract mfrs 7