Drug
Who makes glycopyrrolate?
58 companies list glycopyrrolate as a human prescription drug, including under the names Cuvposa, GLYRX-PF, Glycate. Forms: injection; injection, solution; liquid; solution; tablet. Routes: intramuscular, intravenous, oral.
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 glycopyrrolate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bryant Ranch PrepackUnited States | solution; tablet | ANDA, NDA AUTHORIZED GENERICANDA040653, ANDA090195, ANDA091182 | 15 | 1 |
| Medical Purchasing Solutions, LLCUnited States | injection; injection, solution | ANDAANDA090963, ANDA207639, ANDA208973 | 15 | 1 |
| Hikma Pharmaceuticals USA Inc.United States | injection | ANDA, NDAANDA090963, NDA017558 | 10 | 4 |
| Somerset Therapeutics Private LimitedIndia | injection; solution | ANDAANDA207639, ANDA211705 | 8 | 1 |
| Fresenius Kabi USA, LLCUnited States | injection; injection, solution | ANDA, NDAANDA209024, ANDA209328, NDA214919 | 7 | 6 |
| Xiromed LLCIndia | injection | ANDAANDA212227, ANDA212612 | 7 | 1 |
| Alembic Pharmaceuticals LimitedIndia | injection; tablet | ANDAANDA203657, ANDA214635 | 6 | 7 |
| Amneal Ireland LimitedIreland | injection; injection, solution | ANDAANDA208973, ANDA215333 | 6 | 1 |
| HF Acquisition Co LLCUnited States | injection | ANDAANDA090963, ANDA208973 | 6 | 1 |
| American Regent, Inc.United States | injection, solution | ANDAANDA089335 | 4 | 5 |
| Sandoz Industrial Products S.AAustria | injection | ANDAANDA211334 | 4 | 5 |
| GLAND PHARMA LIMITEDIndia | injection | ANDAANDA212612 | 4 | 4 |
| ProPharma Distribution, LLC.United States | injection; injection, solution | ANDAANDA210842, ANDA210927 | 4 | 3 |
| ACCORD HEALTHCARE LIMITEDUnited Kingdom | injection | ANDAANDA213238 | 4 | 2 |
| Nivagen Pharmaceuticals LLCUnited States | injection | ANDAANDA212591 | 4 | 2 |
| CAPLIN STERILES LIMITEDIndia | injection | ANDAANDA211705 | 4 | 1 |
| Exela Pharma SciencesUnited States | injection, solution | NDANDA210997 | 4 | 1 |
| Henry Schein, Inc.United States | injection, solution | ANDAANDA210083, ANDA210842 | 4 | 1 |
| Piramal Critical Care IncUnited States | injection, solution | ANDAANDA210842 | 4 | 1 |
| RemedyRepack, IncUnited States | tablet | ANDAANDA202675, ANDA207201, ANDA212696 | 4 | 1 |
| AuroMedics Pharma LLC | injection, solution | ANDAANDA210244 | 4 | 0 |
| BE Pharmaceuticals Inc. | injection | ANDAANDA211705 | 4 | 0 |
| Lifestar Pharma LLC. | injection | ANDAANDA217354 | 4 | 0 |
| Solco healthcare U.S., LLC | injection | ANDAANDA210927 | 4 | 0 |
| Par Health USA, LLCIndia | solution; tablet | ANDAANDA040653, ANDA204438 | 3 | 5 |
| QUAGEN PHARMACEUTICALS LLCUnited States | solution; tablet | ANDAANDA212696, ANDA216910 | 3 | 2 |
| Chartwell RX, LLC. | solution; tablet | ANDAANDA207201, ANDA216368 | 3 | 0 |
| Dr. Reddy's Laboratories LimitedIndia | tablet | ANDAANDA040847 | 2 | 15 |
| Aurolife Pharma LLCUnited States | tablet | ANDAANDA202675 | 2 | 3 |
| Civica, Inc. dba CivicaRxUnited States | injection; injection, solution | ANDAANDA089335, ANDA090963 | 2 | 1 |
| Florida Pharmaceutical Products LLCUnited States | tablet | ANDAANDA091182 | 2 | 1 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.United States | tablet | ANDAANDA207201 | 2 | 1 |
| Leading Pharma, LLCUnited States | tablet | ANDAANDA090195 | 2 | 1 |
| Rising Pharma Holdings, Inc.United States | tablet | NDA AUTHORIZED GENERICNDA012827 | 2 | 1 |
| Meitheal Pharmaceuticals, Inc. | injection | ANDAANDA212802 | 2 | 0 |
| Quinn Pharmaceuticals | tablet | ANDAANDA091182 | 2 | 0 |
| Cardinal Health 418, Inc.United States | injection | ANDAANDA090963 | 1 | 34 |
| Granules Pharmaceuticals Inc.India | solution | ANDAANDA214735 | 1 | 8 |
| Aurobindo Pharma LimitedIndia | solution | ANDAANDA214847 | 1 | 6 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet | ANDAANDA202675 | 1 | 5 |
| LGM Pharma Solutions, LLCUnited States | tablet | ANDAANDA091522 | 1 | 4 |
| Merz Pharma GmbH & Co. KGaAGermany | liquid | NDANDA022571 | 1 | 3 |
| AJENAT PHARMACEUTICALS LLCUnited States | solution | ANDAANDA219267 | 1 | 2 |
| Bionpharma Inc.India | solution | ANDAANDA220062 | 1 | 1 |
| Camber Pharmaceuticals, Inc.United States | solution | ANDAANDA213698 | 1 | 1 |
| Golden State Medical Supply Inc.United States | tablet | ANDAANDA091182 | 1 | 1 |
| Jvet Pharmaceuticals LLCUnited States | injection | ANDAANDA212612 | 1 | 1 |
| NCS HealthCare of KY, LLC dba Vangard LabsUnited States | tablet | ANDAANDA202675 | 1 | 1 |
| Precision Dose Inc.United States | solution | ANDAANDA204438 | 1 | 1 |
| Saptalis Pharmaceuticals, LLCUnited States | solution | ANDAANDA216297 | 1 | 1 |
| South Atlantic Corporation LLCUnited States | solution | ANDAANDA213698 | 1 | 1 |
| AvPAK | tablet | ANDAANDA202675 | 1 | 0 |
| FH2 Pharma LLC | tablet | ANDAANDA091522 | 1 | 0 |
| Intra-Sana Laboratories | tablet | ANDAANDA091522 | 1 | 0 |
| MAJOR Pharmaceuticals Inc. | tablet | ANDAANDA207201 | 1 | 0 |
| NorthStar RxLLC | solution | ANDAANDA213698 | 1 | 0 |
| Novadoz Pharmaceuticals LLC | liquid | ANDAANDA216084 | 1 | 0 |
| Sagent Pharmaceuticals | injection, solution | ANDAANDA210083 | 1 | 0 |
Bulk ingredient listings
- Anonima Materie Sintetiche and Affini (AMSA) SpA · 1 NDC
- Cohance Lifesciences LimitedIndia · 1 NDC
- Fagron Services B.V.Netherlands · 1 NDC
- HARMAN FINOCHEM LIMITEDIndia · 1 NDC
- Hikma Pharmaceuticals USA Inc.United States · 1 NDC
- INKE SASpain · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- PCAS Finland OyFinland · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
- Viyash Life Sciences Private Limited · 1 NDC
Orange Book patents
10 unexpired patents list glycopyrrolate as the active ingredient, expiring between Oct 2028 and Dec 2036. Application holders: NOVARTIS PHARMACEUTICALS CORP, SUMITOMO PHARMA AMERICA INC.
Enquiry
Common questions
- Who makes glycopyrrolate?
- 58 companies list glycopyrrolate as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, Medical Purchasing Solutions, LLC, Hikma Pharmaceuticals USA Inc., Somerset Therapeutics Private Limited, 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 Cuvposa?
- 55 companies list glycopyrrolate under an abbreviated new drug application (ANDA), the application type used for generics, and 4 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies glycopyrrolate active ingredient?
- 12 companies list glycopyrrolate as a bulk ingredient, including Anonima Materie Sintetiche and Affini (AMSA) SpA, Cohance Lifesciences Limited, Fagron Services B.V., HARMAN FINOCHEM LIMITED.