Molecules / Octreotide

Octreotide API manufacturers

CAS 83150-76-9 ATC H01CB02 Updated 9 July 2026
23
manufacturers with an active filing 21 of them hold a US DMF or a CEP
61
shortage records on file across 8 countries
246
finished-dose makers across 40 regulators
Showing 20 of 23 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

02

Bachem

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

Holds 2 active US DMFs and one valid CEP for octreotide, filing since 2019. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2024 · VAI
GMP recognised in
2 markets
04

Fresenius Kabi Ab

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

Holds one active US DMF for octreotide, filing since 2020. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 48 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
48 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Auro Peptides

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

Holds one active US DMF and one valid CEP for octreotide, filing since 2015. Its 2024 FDA inspection closed as NAI.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
06

Alembic Pharmaceuticals

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

Holds one active US DMF for octreotide, filing since 2022. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 18 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
18 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Piramal Pharma

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

Holds one active US DMF for octreotide, filing since 2021. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 10 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
10 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

USV

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

Holds one active US DMF for octreotide, filing since 2010. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 9 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
9 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Hybio Pharmaceutical

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

Holds one valid CEP for octreotide, filing since 2022. 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
View profile
10

Bcn Peptides

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

Holds 2 active US DMFs for octreotide, filing since 2005. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 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
11

Chemi

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

Holds one active US DMF for octreotide, filing since 2006. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 8 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
8 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
12

ScinoPharm Taiwan

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

Holds one active US DMF for octreotide, filing since 2015. Its 2022 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
13

Sinopep-Allsino Biopharmaceutical

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

Holds one active US DMF for octreotide, filing since 2017. Its 2024 FDA inspection closed as VAI.

US DMF
1 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
View profile
14

Hainan Shuangcheng Pharmaceuticals

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

Holds one active US DMF for octreotide, filing since 2021. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
15

Chengdu Shengnuo Biopharm

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

Holds one active US DMF for octreotide, filing since 2016. 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
16

Matrix Pharmacorp

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

Holds one active US DMF for octreotide, filing since 2013. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
17

Ambiopharm

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

Holds one active US DMF for octreotide, filing since 2013. 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

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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