Drug
Who makes octreotide acetate?
11 companies list octreotide acetate as a human prescription drug, including under the names BYNFEZIA Pen, Sandostatin, Sandostatin LAR Depot. Forms: injection; injection, solution; kit. Routes: intramuscular, intravenous, subcutaneous.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing octreotide acetate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Novartis Pharmaceuticals CorporationSwitzerland | injection, solution; kit | NDANDA019667, NDA021008 | 6 | 20 |
| Mylan Institutional Inc. | injection, solution; kit | ANDAANDA079198, ANDA216589 | 6 | 0 |
| Hikma Pharmaceuticals USA Inc.United States | injection, solution | ANDAANDA076313, ANDA076330 | 5 | 4 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.United States | injection, solution | ANDAANDA203765, ANDA204669 | 5 | 1 |
| Fresenius Kabi USA, LLCUnited States | injection, solution | ANDAANDA077450, ANDA077457 | 4 | 6 |
| GLAND PHARMA LIMITEDIndia | injection, solution | ANDAANDA216807, ANDA216839 | 4 | 4 |
| Teva Pharmaceutical Industries Ltd.Canada | kit | ANDAANDA210317 | 3 | 6 |
| Meitheal Pharmaceuticals, Inc. | injection, solution | ANDAANDA075957 | 3 | 0 |
| Glenmark Pharmaceuticals Inc., USAIndia | injection, solution | ANDAANDA216839 | 2 | 9 |
| Sun Pharmaceutical Industries LimitedIndia | injection | NDANDA213224 | 1 | 13 |
| Hainan Shuangcheng Pharmaceuticals Co., Ltd.China | injection, solution | ANDAANDA217860 | 1 | 1 |
Bulk ingredient listings
- Assia Chemical Industries Ltd. - Teva Tech SiteIsrael · 1 NDC
- Aurobindo Pharma LimitedIndia · 1 NDC
- Bachem AGSwitzerland · 1 NDC
- Bachem Americas, Inc.United States · 1 NDC
- Chemical & Biopharmaceutical Laboratories of Patras Single Member S.A.Greece · 1 NDC
- Chengdu Shengnuo Biopharm Co., Ltd.China · 1 NDC
- Fresenius Kabi iPSUM S.r.l.Italy · 1 NDC
- Hainan Shuangcheng Pharmaceuticals Co., Ltd.China · 1 NDC
- Matrix Pharmacorp Private LimitedIndia · 1 NDC
- Polypeptide Laboratories Private LtdUnited States · 1 NDC
- ScinoPharm Taiwan, Ltd.Taiwan · 1 NDC
- Sinopep-Allsino Biopharmaceutical Co., Ltd.China · 1 NDC
- Sterling Pharmaceutical Services, LLCUnited States · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
Orange Book patents
21 unexpired patents list octreotide acetate as the active ingredient, expiring between Sept 2029 and Dec 2041. Application holders: CHIESI FARMACEUTICI SPA, SUN PHARMACEUTICAL INDUSTRIES LTD.
Enquiry
Common questions
- Who makes octreotide acetate?
- 11 companies list octreotide acetate as a human prescription drug in the openFDA NDC Directory, led by Novartis Pharmaceuticals Corporation, Mylan Institutional Inc., Hikma Pharmaceuticals USA Inc., Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., Fresenius Kabi USA, LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic BYNFEZIA Pen?
- 9 companies list octreotide acetate under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies octreotide acetate active ingredient?
- 14 companies list octreotide acetate as a bulk ingredient, including Assia Chemical Industries Ltd. - Teva Tech Site, Aurobindo Pharma Limited, Bachem AG, Bachem Americas, Inc..