Drug
Who makes phenylephrine hydrochloride?
37 companies list phenylephrine hydrochloride as a human prescription drug, including under the names Biorphen, IMMPHENTIV. Forms: injectable, liposomal; injection; injection, solution; solution; solution/ drops. Routes: intravenous, ophthalmic.
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 phenylephrine hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Somerset Therapeutics Private LimitedIndia | injection; solution | ANDAANDA213318, ANDA215617 | 7 | 1 |
| Lifestar Pharma LLC. | injection; solution/ drops | ANDAANDA216496, ANDA216859, ANDA217069 | 7 | 0 |
| Sandoz Industrial Products S.AAustria | injection | ANDAANDA208905 | 6 | 5 |
| GLAND PHARMA LIMITEDIndia | injection; solution/ drops | ANDAANDA211920, ANDA218129 | 6 | 4 |
| Hikma Pharmaceuticals USA Inc.United States | injectable, liposomal; injection | NDANDA203826 | 6 | 4 |
| CAPLIN STERILES LIMITEDIndia | injection; solution/ drops | ANDAANDA213318, ANDA215183 | 6 | 1 |
| Medical Purchasing Solutions, LLCUnited States | injection | ANDA, NDAANDA210334, ANDA210696, ANDA211079 | 6 | 1 |
| Dr. Reddy's Laboratories LimitedIndia | injection, solution; solution/ drops | ANDA, NDAANDA218129, NDA212909 | 5 | 15 |
| Baxter Healthcare CorporationUnited States | injection | ANDAANDA217032 | 3 | 16 |
| Xellia Pharmaceuticals ApSDenmark | injection | ANDAANDA213318 | 3 | 3 |
| Amneal Ireland LimitedIreland | injection | ANDAANDA211078, ANDA211079 | 3 | 1 |
| Camber Pharmaceuticals, Inc.United States | injection | ANDAANDA218110 | 3 | 1 |
| Hainan Poly Pharm. Co., Ltd.China | injection | ANDAANDA218412 | 3 | 1 |
| Armas Pharmaceuticals, Inc. | injection | ANDAANDA213318 | 3 | 0 |
| BE Pharmaceuticals Inc. | injection | ANDAANDA217521 | 3 | 0 |
| Eugia US LLC | injection | ANDAANDA210696, ANDA210697 | 3 | 0 |
| Method Pharmaceuticals, LLC. | injection | ANDAANDA218412 | 3 | 0 |
| Novadoz Pharmaceuticals LLC | injection | ANDAANDA217521 | 3 | 0 |
| Provepharm Inc. | injection | ANDAANDA211081 | 3 | 0 |
| Fresenius Kabi USA, LLCUnited States | injection | ANDAANDA210665 | 2 | 6 |
| Par Health USA, LLCIndia | injection | ANDAANDA210025 | 2 | 5 |
| Alcon Laboratories, IncUnited States | solution/ drops | NDANDA207926 | 2 | 3 |
| Civica, Inc. dba CivicaRxUnited States | injection | NDANDA203826 | 2 | 1 |
| Leading Pharma, LLCUnited States | solution | ANDAANDA215183 | 2 | 1 |
| Bausch & Lomb Americas Inc. | solution/ drops | NDA AUTHORIZED GENERICNDA203510 | 2 | 0 |
| First Nation Group, LLC | solution/ drops | ANDAANDA216496, ANDA216859 | 2 | 0 |
| Meitheal Pharmaceuticals, Inc. | injection | ANDAANDA210333, ANDA210334 | 2 | 0 |
| NorthStar RxLLC | solution/ drops | ANDAANDA216496, ANDA216859 | 2 | 0 |
| Paragon BioTeck, Inc. | solution/ drops | NDANDA203510 | 2 | 0 |
| SOLA Pharmaceuticals, LLC | solution/ drops | ANDAANDA215183 | 2 | 0 |
| Cardinal Health 418, Inc.United States | injection | ANDAANDA211079 | 1 | 34 |
| ProPharma Distribution, LLC.United States | injection | ANDAANDA217069 | 1 | 3 |
| HF Acquisition Co LLCUnited States | injection | ANDAANDA210665 | 1 | 1 |
| Henry Schein, Inc.United States | injection | ANDAANDA211079 | 1 | 1 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.United States | injection | ANDAANDA209968 | 1 | 1 |
| Medical Purhasing Solutions, LLC | injection | ANDAANDA211081 | 1 | 0 |
| Sagent Pharmaceuticals | injection, solution | ANDAANDA209967 | 1 | 0 |
Bulk ingredient listings
- Professional Compounding Centers of America dba PCCAUnited States · 2 NDC
- Spera Nexus IncJapan · 2 NDC
- Boehringer Ingelheim Biopharmaceuticals China LtdGermany · 1 NDC
- Cheng Fong Chemical Co., Ltd.Taiwan · 1 NDC
- DIVI'S LABORATORIES LIMITEDIndia · 1 NDC
- Fagron Services B.V.Netherlands · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- Malladi Drugs & Pharmaceuticals LimitedIndia · 1 NDC
- SHILPA PHARMA LIFESCIENCES LIMITEDIndia · 1 NDC
- Shenzhen Oriental Pharmaceutical Co. LtdChina · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
- Syn-Tech Chem. & Pharm. Co., Ltd.Taiwan · 1 NDC
Orange Book patents
5 unexpired patents list phenylephrine hydrochloride as the active ingredient, expiring between Nov 2033 and Aug 2044. Application holders: DR REDDYS LABORATORIES SA, HIKMA PHARMACEUTICALS USA INC, PARAGON BIOTECK INC.
Enquiry
Common questions
- Who makes phenylephrine hydrochloride?
- 37 companies list phenylephrine hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Somerset Therapeutics Private Limited, Lifestar Pharma LLC., Sandoz Industrial Products S.A, GLAND PHARMA LIMITED, Hikma Pharmaceuticals USA 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 Biorphen?
- 32 companies list phenylephrine hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 6 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies phenylephrine hydrochloride active ingredient?
- 13 companies list phenylephrine hydrochloride as a bulk ingredient, including Professional Compounding Centers of America dba PCCA, Spera Nexus Inc, Boehringer Ingelheim Biopharmaceuticals China Ltd, Cheng Fong Chemical Co., Ltd..