Drug
Who makes buprenorphine hydrochloride?
9 companies list buprenorphine hydrochloride as a human prescription drug, including under the names BELBUCA. Forms: film, soluble; injection; injection, solution; tablet. Routes: buccal, intramuscular, intravenous, sublingual.
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 buprenorphine hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| BioDelivery Sciences International Inc | film, soluble | NDANDA207932 | 7 | 0 |
| Advagen Pharma Limited | tablet | ANDAANDA090279 | 4 | 0 |
| PAI Holdings, LLCUnited States | tablet | ANDAANDA090622 | 2 | 1 |
| RemedyRepack, IncUnited States | tablet | ANDAANDA090279, ANDA090622 | 2 | 1 |
| Hospira, Inc.United States | injection, solution | ANDAANDA074137 | 1 | 7 |
| Par Health USA, LLCIndia | injection | ANDAANDA206586 | 1 | 5 |
| Hikma Pharmaceuticals USA Inc.United States | injection | ANDAANDA076931 | 1 | 4 |
| International Medication Systems, Ltd.United States | tablet | ANDAANDA090622 | 1 | 3 |
| Somerset Therapeutics Private LimitedIndia | injection | ANDAANDA219302 | 1 | 1 |
Bulk ingredient listings
- SpecGx LLCUnited States · 4 NDC
- Siegfried USA, LLCUnited States · 2 NDC
- Arevipharma GmbHGermany · 1 NDC
- Chattem Chemicals, Inc.United States · 1 NDC
- Chr. Olesen Synthesis A/SDenmark · 1 NDC
- Indivior Inc.United States · 1 NDC
- Janssen Pharmaceuticals Sciences Unlimited Company · 1 NDC
- Janssen Pharmaceuticals, Inc. · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- Macfarlan Smith LimitedUnited Kingdom · 1 NDC
- Noramco Coventry LLC · 1 NDC
- Noramco, LLCUnited States · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
- TAPI Czech Industries s.r.o.Czechia · 1 NDC
- Teva Czech Industries s.r.o.Czechia · 1 NDC
- Unichem Laboratories Limited, IndiaIndia · 1 NDC
Orange Book patents
3 unexpired patents list buprenorphine hydrochloride as the active ingredient, expiring between Jul 2027 and Dec 2032. Application holder: BIODELIVERY SCIENCES INTERNATIONAL INC.
Enquiry
Common questions
- Who makes buprenorphine hydrochloride?
- 9 companies list buprenorphine hydrochloride as a human prescription drug in the openFDA NDC Directory, led by BioDelivery Sciences International Inc, Advagen Pharma Limited, PAI Holdings, LLC, RemedyRepack, Inc, Hospira, Inc.. 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 BELBUCA?
- 8 companies list buprenorphine hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies buprenorphine hydrochloride active ingredient?
- 18 companies list buprenorphine hydrochloride as a bulk ingredient, including SpecGx LLC, Siegfried USA, LLC, Arevipharma GmbH, Chattem Chemicals, Inc..