somatostatin analogue

Octreotide companies

Answer

Public registers name 17 licence holders, 18 bulk ingredient labelers, 13 US labelers, 155 trial sponsors and 5 recalling firms for Octreotide.

Each row is what a register states. A company named here is not endorsed or accused by this site.

MARKETING AUTHORISATION HOLDER

17 companies

Holds the licence to sell the medicine in a country (EMA, MHRA, Health Canada).

Amryt Pharmaceuticals DAC
Mycapssa (EMEA/H/C/005826), Withdrawn Regulator EMA
Camurus AB
Oczyesa (EMEA/H/C/006322), Authorised Regulator EMA
OCZYESA 20 MG PROLONGED-RELEASE SOLUTION FOR INJECTION IN PRE-FILLED PEN, PL 42800/0011, Authorised Regulator MHRA
CHEMI SPA MILAN ITALY
OCTREOTIDE 100 MICROGRAMS/ML SOLUTION FOR INJECTION IN PREFILLED SYRINGE, PL 04465/0006, Authorised Regulator MHRA
OCTREOTIDE 50 MICROGRAMS/ML SOLUTION FOR INJECTION IN PREFILLED SYRINGE, PL 04465/0005, Authorised Regulator MHRA
OCTREOTIDE 500 MICROGRAMS/ML SOLUTION FOR INJECTION IN PREFILLED SYRINGE, PL 04465/0007, Authorised Regulator MHRA
GENERIC MEDICAL PARTNERS INC
OCTREOTIDE ACETATE INJECTION (DIN 02509741), Approved Regulator Health Canada
OCTREOTIDE ACETATE INJECTION (DIN 02509768), Approved Regulator Health Canada
OCTREOTIDE ACETATE INJECTION (DIN 02509776), Approved Regulator Health Canada
HOSPIRA UK LIMITED
OCTREOTIDE 100 MICROGRAMS/1 ML SOLUTION FOR INJECTION, PL 04515/0218, Authorised Regulator MHRA
OCTREOTIDE 50 MICROGRAMS/1 ML SOLUTION FOR INJECTION, PL 04515/0217, Authorised Regulator MHRA
OCTREOTIDE 500 MICROGRAMS/1 ML SOLUTION FOR INJECTION, PL 04515/0220, Authorised Regulator MHRA
MONT-PHARMA INC
OCTREOTIDE INJECTION (DIN 02535890), Approved Regulator Health Canada
OCTREOTIDE INJECTION (DIN 02535904), Approved Regulator Health Canada
OCTREOTIDE INJECTION (DIN 02535912), Approved Regulator Health Canada
and 1 more entries
NOVARTIS IRELAND LIMITED
SANDOSTATIN AMPOULES 100 MCG/ML SOLUTION FOR INJECTION OR CONCENTRATE FOR SOLUTION FOR INFUSION, PL 23860/0031, Authorised Regulator MHRA
SANDOSTATIN AMPOULES 50 MCG/ML SOLUTION FOR INJECTION OR CONCENTRATE FOR SOLUTION FOR INFUSION, PL 23860/0030, Authorised Regulator MHRA
SANDOSTATIN AMPOULES 500 MCG/ML SOLUTION FOR INJECTION OR CONCENTRATE FOR SOLUTION FOR INFUSION, PL 23860/0032, Authorised Regulator MHRA
and 3 more entries
NOVARTIS PHARMACEUTICALS CANADA INC
SANDOSTATIN (DIN 00839191), Marketed Regulator Health Canada
SANDOSTATIN (DIN 00839205), Cancelled Post Market Regulator Health Canada
SANDOSTATIN (DIN 00839213), Cancelled Post Market Regulator Health Canada
and 4 more entries
OMEGA LABORATORIES LIMITED
OCTREOTIDE ACETATE OMEGA (DIN 02248639), Marketed Regulator Health Canada
OCTREOTIDE ACETATE OMEGA (DIN 02248640), Marketed Regulator Health Canada
OCTREOTIDE ACETATE OMEGA (DIN 02248641), Marketed Regulator Health Canada
and 1 more entries
PENDOPHARM DIVISION OF PHARMASCIENCE INC
OCPHYL (DIN 02413191), Cancelled Post Market Regulator Health Canada
OCPHYL (DIN 02413205), Cancelled Post Market Regulator Health Canada
OCPHYL (DIN 02413213), Cancelled Post Market Regulator Health Canada
ROTOP PHARMAKA GMBH
TEKTROTYD 16 MICROGRAM KIT FOR RADIOPHARMACEUTICAL PREPARATION, PL 45925/0001, Authorised Regulator MHRA
SANDOZ CANADA INCORPORATED
OCTREOTIDE ACETATE INJECTION - 100MCG/ML (DIN 02263173), Cancelled Pre Market Regulator Health Canada
OCTREOTIDE ACETATE INJECTION - 200MCG/ML (DIN 02263181), Cancelled Pre Market Regulator Health Canada
OCTREOTIDE ACETATE INJECTION - 500MCG/ML (DIN 02263203), Cancelled Pre Market Regulator Health Canada
and 1 more entries
SEACROSS PHARMACEUTICALS LIMITED
OCTREOTIDE 100 MICROGRAM/ML SOLUTION FOR INJECTION/INFUSION, PL 41013/0024, Authorised Regulator MHRA
STERIMAX INC
OCTREOTIDE DEPOT (DIN 02567776), Marketed Regulator Health Canada
OCTREOTIDE DEPOT (DIN 02567784), Marketed Regulator Health Canada
OCTREOTIDE DEPOT (DIN 02567792), Marketed Regulator Health Canada
and 3 more entries
SUN PHARMACEUTICAL INDUSTRIES EUROPE BV
OCTREOTIDE 100 MICROGRAMS/ML SOLUTION FOR INJECTION, PL 31750/0084, Authorised Regulator MHRA
OCTREOTIDE 200 MICROGRAMS/ML SOLUTION FOR INJECTION, PL 31750/0086, Authorised Regulator MHRA
OCTREOTIDE 50 MICROGRAMS/ML SOLUTION FOR INJECTION, PL 31750/0083, Authorised Regulator MHRA
and 1 more entries
TEVA CANADA LIMITED
OCTREOTIDE FOR INJECTABLE SUSPENSION (DIN 02503751), Cancelled Post Market Regulator Health Canada
OCTREOTIDE FOR INJECTABLE SUSPENSION (DIN 02503778), Cancelled Post Market Regulator Health Canada
OCTREOTIDE FOR INJECTABLE SUSPENSION (DIN 02503786), Cancelled Post Market Regulator Health Canada
and 4 more entries
TEVA UK LIMITED
OLATUTON 10 MG POWDER AND SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION, PL 00289/2219, Authorised Regulator MHRA
OLATUTON 20 MG POWDER AND SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION, PL 00289/2220, Authorised Regulator MHRA
OLATUTON 30 MG POWDER AND SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION, PL 00289/2221, Authorised Regulator MHRA

BULK INGREDIENT LABELER

18 companies

Lists the bulk active ingredient with FDA (NDC directory).

Ambiopharm, Inc.
Octreotide, BULK INGREDIENT Regulator openFDA
Assia Chemical Industries Ltd - Teva Tech Site
Octreotide Acetate, BULK INGREDIENT Regulator openFDA
Aurobindo Pharma Limited
Octreotide Acetate, BULK INGREDIENT Regulator openFDA
Bachem AG
Octreotide Acetate, BULK INGREDIENT Regulator openFDA
Octreotide Hydrochloride, BULK INGREDIENT Regulator openFDA
Bachem Americas, Inc.
Octreotide Acetate, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING Regulator openFDA
Octreotide, BULK INGREDIENT Regulator openFDA
BCN PEPTIDES SA
Octreotide, BULK INGREDIENT Regulator openFDA
Chemical & Biopharmaceutical Laboratories of Patras Single Member S.A.
Octreotide acetate, BULK INGREDIENT Regulator openFDA
Chengdu Shengnuo Biopharm Co. Ltd.
Octreotide Acetate, BULK INGREDIENT Regulator openFDA
FRESENIUS KABI IPSUM SRL
OCTREOTIDE ACETATE, BULK INGREDIENT Regulator openFDA
Hainan Shuangcheng Pharmaceuticals Co., Ltd.
octreotide acetate, BULK INGREDIENT Regulator openFDA
LSNE, Inc.
Octreotide, BULK INGREDIENT Regulator openFDA
Matrix Pharmacorp Private Limited
OCTREOTIDE ACETATE, BULK INGREDIENT Regulator openFDA
PolyPeptide Laboratories, Pvt. Ltd.
Octreotide Acetate, BULK INGREDIENT Regulator openFDA
ScinoPharm Taiwan Ltd.
Octreotide Acetate, BULK INGREDIENT Regulator openFDA
Sinopep-Allsino Biopharmaceutical Co., Ltd.
octreotide acetate, BULK INGREDIENT Regulator openFDA
Sterling Pharma Solutions Limited
Octreotide acetate, BULK INGREDIENT Regulator openFDA
SUN PHARMACEUTICAL INDUSTRIES INC
Octreotide Acetate, BULK INGREDIENT Regulator openFDA
USV Private Limited
Octreotide, BULK INGREDIENT Regulator openFDA

US LABELER

13 companies

Lists a finished product with FDA (NDC directory); can be a maker, repackager or distributor.

Amryt Pharmaceuticals Designated Activity Company
Mycapssa, NDA Regulator openFDA
Chiesi USA, Inc.
Mycapssa, NDA Regulator openFDA
Fresenius Kabi USA, LLC
Octreotide, ANDA Regulator openFDA
Gland Pharma Limited
Octreotide Acetate, ANDA Regulator openFDA
Glenmark Pharmaceuticals Inc., USA
Octreotide Acetate, ANDA Regulator openFDA
Hainan Shuangcheng Pharmaceuticals Co., Ltd.
OCTREOTIDE ACETATE, ANDA Regulator openFDA
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
OCTREOTIDE ACETATE, ANDA Regulator openFDA
Hikma Pharmaceuticals USA Inc.
Octreotide Acetate, ANDA Regulator openFDA
Meitheal Pharmaceuticals, Inc
Octreotide Acetate, ANDA Regulator openFDA
Mylan Institutional LLC
Octreotide Acetate, ANDA Regulator openFDA
OCTREOTIDE ACETATE, ANDA Regulator openFDA
Novartis Pharmaceuticals Corporation
Sandostatin LAR Depot, NDA Regulator openFDA
Sandostatin, NDA Regulator openFDA
SUN PHARMACEUTICAL INDUSTRIES INC
BYNFEZIA Pen, NDA Regulator openFDA
Teva Pharmaceuticals, Inc.
Octreotide Acetate, ANDA Regulator openFDA

TRIAL SPONSOR

155 companies

Sponsors registered clinical trials of the peptide.

Novartis Pharmaceuticals
21 registered trials Trial register ClinicalTrials.gov
Camurus AB
3 registered trials Trial register EU CTIS
6 registered trials Trial register ClinicalTrials.gov
Novartis
8 registered trials Trial register ClinicalTrials.gov
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
5 registered trials Trial register ClinicalTrials.gov
Federico II University
5 registered trials Trial register ClinicalTrials.gov
Aspireo Pharmaceuticals Limited
4 registered trials Trial register ClinicalTrials.gov
Columbia University
4 registered trials Trial register ClinicalTrials.gov
Eastern Cooperative Oncology Group
4 registered trials Trial register ClinicalTrials.gov
Endo USA Inc., a Keenova Therapeutics Company
4 registered trials Trial register ClinicalTrials.gov
Ipsen
4 registered trials Trial register ClinicalTrials.gov
National Cancer Institute (NCI)
4 registered trials Trial register ClinicalTrials.gov
Advanced Accelerator Applications
1 registered trial Trial register EU CTIS
2 registered trials Trial register ClinicalTrials.gov
Alliance for Clinical Trials in Oncology
3 registered trials Trial register ClinicalTrials.gov
Chiasma, Inc.
3 registered trials Trial register ClinicalTrials.gov
Mario Negri Institute for Pharmacological Research
3 registered trials Trial register ClinicalTrials.gov
National Hepatology & Tropical Medicine Research Institute
3 registered trials Trial register ClinicalTrials.gov
Radboud University Medical Center
3 registered trials Trial register ClinicalTrials.gov
Shanghai Zhongshan Hospital
3 registered trials Trial register ClinicalTrials.gov
St. James's Hospital, Ireland
3 registered trials Trial register ClinicalTrials.gov
Universitaire Ziekenhuizen KU Leuven
3 registered trials Trial register ClinicalTrials.gov
Cedars-Sinai Medical Center
2 registered trials Trial register ClinicalTrials.gov
Chemi S.p.A.
2 registered trials Trial register ClinicalTrials.gov
Duke University
2 registered trials Trial register ClinicalTrials.gov
Grupo Espanol de Tumores Neuroendocrinos
2 registered trials Trial register ClinicalTrials.gov
Italfarmaco
2 registered trials Trial register ClinicalTrials.gov
Lexicon Pharmaceuticals
2 registered trials Trial register ClinicalTrials.gov
Mayo Clinic
2 registered trials Trial register ClinicalTrials.gov
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
2 registered trials Trial register ClinicalTrials.gov
Peking University
2 registered trials Trial register ClinicalTrials.gov
Rayzebio Inc.
1 registered trial Trial register EU CTIS
1 registered trial Trial register ClinicalTrials.gov
Roswell Park Cancer Institute
2 registered trials Trial register ClinicalTrials.gov
Sandoz
2 registered trials Trial register ClinicalTrials.gov
Sue O'Dorisio
2 registered trials Trial register ClinicalTrials.gov
University of Aarhus
2 registered trials Trial register ClinicalTrials.gov
University of Turin, Italy
2 registered trials Trial register ClinicalTrials.gov
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 registered trial Trial register ClinicalTrials.gov
AdventHealth
1 registered trial Trial register ClinicalTrials.gov
AdventHealth Translational Research Institute
1 registered trial Trial register ClinicalTrials.gov
Aga Khan University
1 registered trial Trial register ClinicalTrials.gov
Albert Einstein Healthcare Network
1 registered trial Trial register ClinicalTrials.gov

Showing 40 of 155.

RECALLING FIRM

5 companies

Recalled a product naming the peptide (FDA enforcement report).

Ben Venue Laboratories Inc
Class II recall, Terminated, 2012-06-20 Regulator openFDA
Fresenius Kabi USA, LLC
Class II recall, Terminated, 2016-06-01 Regulator openFDA
Teva Pharmaceuticals USA
Class II recall, Terminated, 2021-08-25 Regulator openFDA
Teva Pharmaceuticals USA, Inc
Class II recall, Ongoing, 2026-04-01 Regulator openFDA
Class II recall, Ongoing, 2026-05-13 Regulator openFDA
Viatris Inc
Class I recall, Terminated, 2022-11-16 Regulator openFDA

Every company across all peptides: companies. Names are matched only when identical apart from case and punctuation, so one group can appear under two spellings.

WEEKLY

Register Watch, weekly

New trials, approvals and enforcement actions. One email a week.