Anticholinergic, Cholinergic Muscarinic Antagonist
Where is Glycopyrronium made?
54 companies sell it under their own name and 17 repackagers rebottle it. Their labels name 32 factories in India, the United States, Portugal, China and Spain.
India 15United States 14Portugal 1China 1Spain 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Accord Healthcare Inc.0.2 mg per 1 mL · NDC 16729-471, 16729-472, 16729-473 +1 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | No problems foundJul 2024 |
| Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | Serious problems, FDA actionDec 2022 | |
| Civica, Inc.0.2 mg per 1 mL · NDC 72572-225, 72572-226 | American Regent, Inc.Makes it and tests it | Shirley, NY, United States | Problems found, fixed voluntarilyApr 2024 |
| Hikma Farmaceutica (portugal), S.aMakes it and tests it | Terrugem Sintra, Portugal | Problems found, fixed voluntarilyApr 2023 | |
| Fresenius Kabi, LLC Glycopyrrolate0.2 mg per 1 mL · NDC 63323-578, 76045-203, 76045-206 +3 | Fresenius Kabi USA, LLCMakes it and tests it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 |
| Fresenius Kabi USA, LLCMakes it and tests it | Wilson, NC, United States | Problems found, fixed voluntarilyFeb 2026 | |
| Quagen Pharmaceuticals LLC1 mg, 1 mg per 5 mL, 2 mg · NDC 70752-108, 70752-175, 70752-109 | Quagen Pharmaceuticals LLCMakes it and packages it | West Caldwell, NJ, United States | No problems foundApr 2026 |
| Quagen Pharmaceuticals LLCMakes it and packages it | West Caldwell, NJ, United States | No problems foundApr 2026 | |
| Somerset Therapeutics, LLC0.2 mg per 1 mL · NDC 70069-011, 70069-012, 70069-013 +5 | Caplin Steriles LimitedMakes it, tests it and packages it | Gummidipoondi, India | No problems foundAug 2024 |
| Somerset Therapeutics Private LimitedMakes it, tests it, packages it and labels it | Bengaluru, India | Serious problems, FDA actionFeb 2025 | |
| Xiromed, LLC.0.2 mg per 1 mL · NDC 70700-264, 70700-165, 70700-166 +4 | Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJun 2023 |
| Universal Farma SLMakes it, tests it and sterilizes it | Guadalajara, Spain | Problems found, fixed voluntarilyJun 2024 | |
| Ajenat Pharmaceuticals LLC1 mg per 5 mL · NDC 82983-428 | Ajenat Pharmaceuticals LLCMakes it and tests it | Largo, FL, United States | No problems foundFeb 2025 |
| Alembic Pharmaceuticals Inc.0.2 mg per 1 mL · NDC 62332-607, 62332-627, 62332-628 +1 | Alembic Pharmaceuticals LimitedMakes it | Vadodara, India | Problems found, fixed voluntarilyFeb 2026 |
| American Regent, Inc.0.2 mg per 1 mL · NDC 0517-4601, 0517-4602, 0517-4605 +1 | American Regent, Inc.Makes it and tests it | Shirley, NY, United States | Problems found, fixed voluntarilyApr 2024 |
| Amneal Pharmaceuticals LLC0.2 mg per 1 mL, 0.4 mg per 2 mL, 1 mg per 5 mL, 4 mg per 20 mL · NDC 70121-1698, 70121-1699, 70121-1394 +3 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and sterilizes it | Ahmedabad, India | No problems foundJun 2024 |
| AuroMedics Pharma LLC0.2 mg per 1 mL · NDC 55150-292, 55150-293, 55150-294 +1 | Eugia Pharma Specialities LimitedMakes it and tests it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| Aurobindo Pharma Limited1 mg per 5 mL · NDC 59651-435 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| Aurolife Pharma LLC1 mg, 2 mg · NDC 13107-014, 13107-015 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| BE Pharmaceuticals Inc.0.2 mg per 1 mL, 0.4 mg per 2 mL, 1 mg per 5 mL, 4 mg per 20 mL · NDC 71839-123, 71839-124, 71839-125 +1 | Caplin Steriles LimitedMakes it, tests it and packages it | Gummidipoondi, India | No problems foundAug 2024 |
| Bionpharma Inc.1 mg per 5 mL · NDC 69452-406 | OrBion Pharmaceuticals Private LimitedMakes it and tests it | Kancheepuram, India | No problems foundOct 2025 |
| Camber Pharmaceuticals Inc.1 mg per 5 mL · NDC 31722-016 | Annora Pharma Private LimitedMakes it and tests it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| Caplin Steriles Limited0.2 mg per 1 mL, 0.4 mg per 2 mL, 1 mg per 5 mL, 4 mg per 20 mL · NDC 65145-102, 65145-103, 65145-104 +1 | Caplin Steriles LimitedMakes it, tests it and packages it | Gummidipoondi, India | No problems foundAug 2024 |
| Caraco Pharmaceutical Laboratories, Ltd.1 mg per 5 mL · NDC 51672-5316 | Cohance Lifesciences LimitedMakes it, makes the active ingredient, tests it, packages it and labels it | Sangareddy, India | No problems foundFeb 2024 |
| Dr.Reddy's Laboratories Ltd.1 mg · NDC 55111-648, 55111-649 | USV Private LimitedMakes it and tests it | Daman, India | Serious problems, FDA actionApr 2026 |
| Excellium Pharmaceutical Inc.1 mg, 2 mg · NDC 64125-139, 64125-140 | Excellium Pharmaceutical Inc.Makes it | Location not on file | Not inspected on record |
| Exela Pharma Sciences, LLC Glyrx-Pf0.2 mg per 1 mL · NDC 51754-6015, 51754-6000, 51754-6001 +1 | Exela Pharma Sciences, LLC.Makes it, tests it, packages it and labels it | Lenoir, NC, United States | Serious problems, FDA actionNov 2024 |
| FH2 Pharma LLC1.5 mg · NDC 72887-160 | LGM Pharma Solutions, LLCMakes it | Irvine, CA, United States | No problems foundJan 2025 |
| Florida Pharmaceutical Products, LLC.1 mg, 2 mg · NDC 69076-475, 71921-110, 69076-476 +1 | Contract Pharmacal Corp.Makes it, tests it, packages it and labels it | Hauppauge, NY, United States | Problems found, fixed voluntarilyApr 2022 |
| Fresenius Kabi USA, LLC0.2 mg per 1 mL · NDC 65219-801 | Fresenius Kabi USA, LLCMakes it and tests it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 |
| Gland Pharma Limited0.2 mg per 1 mL · NDC 68083-376, 68083-377, 68083-378 +1 | Gland Pharma LimitedMakes it, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJun 2023 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1 mg, 2 mg · NDC 23155-606, 23155-607 | Appco Pharma LLCMakes it, tests it and packages it | Piscataway, NJ, United States | Problems found, fixed voluntarilyMay 2026 |
| Hikma Pharmaceuticals USA Inc.0.2 mg per 1 mL · NDC 0143-9587, 0143-9586, 0143-9585 +5 | Hikma Farmaceutica (portugal), S.aMakes it, tests it, packages it and labels it | Terrugem Sintra, Portugal | Problems found, fixed voluntarilyApr 2023 |
| Journey Medical Corporation Qbrexza2.4 g per 100 g · NDC 69489-411 | Aphena Pharma Solutions - Maryland, LLCMakes it | Easton, MD, United States | Problems found, fixed voluntarilyFeb 2026 |
| Jvet Pharmaceuticals LLC0.2 mg per 1 mL · NDC 86211-113 | Gland Pharma LimitedMakes it, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJun 2023 |
| LGM Pharma Solutions, LLC1.5 mg · NDC 79739-7097 | LGM Pharma Solutions, LLCMakes it, tests it, packages it and labels it | Irvine, CA, United States | No problems foundJan 2025 |
| Leading Pharma, LLC1 mg, 2 mg · NDC 69315-139, 69315-140 | Leading Pharma, LLCMakes it | Fairfield, NJ, United States | Problems found, fixed voluntarilyOct 2024 |
| Lifestar Pharma LLC.0.2 mg per 1 mL · NDC 70756-631, 70756-632, 70756-633 +1 | Mankind Pharma LimitedMakes it, tests it and packages it | Sirmaur, India | Problems found, fixed voluntarilyFeb 2022 |
| Lupin Pharmaceuticals, Inc.0.2 mg per 1 mL, 0.4 mg per 2 mL, 1 mg per 5 mL, 4 mg per 20 mL · NDC 70748-136, 70748-137, 70748-138 +1 | Lupin LimitedMakes it and packages it | Nagpur, India | Problems found, fixed voluntarilyJul 2023 |
| Meitheal Pharmaceuticals Inc.0.2 mg per 1 mL · NDC 71288-414, 71288-415 | Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd (API and FDF Site)Makes it | Nanjing, China | Problems found, fixed voluntarilyNov 2023 |
| Nexgen Pharma, Inc.1.5 mg · NDC 0722-7097 | Nexgen Pharma, Inc.Makes it, tests it, packages it and labels it | Location not on file | Not inspected on record |
| Northstar Rx LLC.1 mg per 5 mL · NDC 72603-240 | Annora Pharma Private LimitedMakes it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| Novadoz Pharmaceuticals LLC1 mg per 5 mL · NDC 72205-070 | MSN Pharmaceuticals IncMakes it and tests it | Piscataway, NJ, United States | No problems foundMar 2026 |
| Nuro Pharma, Inc.1.5 mg · NDC 59547-210 | Nexgen Pharma, Inc.Makes it, tests it, packages it and labels it | Location not on file | Not inspected on record |
| Orit Laboratories LLC1 mg, 2 mg · NDC 15955-305, 15955-318 | Appco Pharma LLCMakes it | Piscataway, NJ, United States | Problems found, fixed voluntarilyMay 2026 |
| Ranbaxy Laboratories Inc.1 mg, 2 mg · NDC 63304-210, 63304-211 | Ohm Laboratories Inc.Makes it | New Brunswick, NJ, United States | No problems foundOct 2024 |
| Rising Pharma Holdings, Inc.1 mg, 2 mg · NDC 16571-743, 16571-744 | Cohance Lifesciences LimitedMakes it, makes the active ingredient, tests it, packages it and labels it | Sangareddy, India | No problems foundFeb 2024 |
| Chartwell RX, LLC.1 mg, 1 mg per 5 mL, 2 mg · NDC 62135-734, 62135-961, 62135-735 | The label doesn't name the factory. Plants this company names for other drugs | ||
| ENDO USA, Inc.1 mg per 5 mL · NDC 49884-042 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Granules Pharmaceuticals Inc.1 mg per 5 mL · NDC 70010-106 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hikma Pharmaceuticals USA Inc. Glycopyrrolate0.2 mg per 1 mL · NDC 0641-6212, 0641-6213 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Intra-Sana Laboratories1.5 mg · NDC 80056-160 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Merz Pharmaceuticals, LLC Cuvposa1 mg per 5 mL · NDC 0259-0501 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Nivagen Pharmaceuticals, Inc.0.2 mg per 1 mL · NDC 75834-193, 75834-194, 75834-195 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Par Health USA, LLC1 mg, 2 mg · NDC 49884-065, 49884-066 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Piramal Critical Care Inc.0.2 mg per 1 mL · NDC 66794-205, 66794-202, 66794-203 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals0.2 mg per 1 mL · NDC 25021-796 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc.0.2 mg per 1 mL, 0.4 mg per 2 mL, 1 mg per 5 mL, 4 mg per 20 mL · NDC 0781-3825, 0781-3827, 0781-3829 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Saptalis Pharmaceuticals, LLC.1 mg per 5 mL · NDC 71656-061 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Solco Healthcare U.S., LLC0.2 mg per 1 mL, 0.4 mg per 2 mL · NDC 43547-639, 43547-543, 43547-640 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Glycopyrronium in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- A-S Medication Solutions:
50090-5227,50090-4513,50090-5226,50090-6113+1 - American Health Packaging:
60687-458 - Atlantic Biologicals Corps.:
17856-1016 - AvPAK:
50268-363 - Bryant Ranch Prepack:
71335-2075,71335-9652,72162-1477,72162-2597+11 - Cardinal Health 107, LLC:
55154-7475 - Carilion Materials Management:
68151-0614 - Golden State Medical Supply, Inc.:
60429-665,60429-666 - HF Acquisition Co. LLC. DBA HealthFirst:
51662-1601,51662-1554,51662-1487,51662-1425+2 - Henry Schein, Inc.:
0404-9782,0404-9776,0404-9775,0404-9777 - Major Pharmaceuticals:
0904-6709 - Medical Purchasing Solutions, LLC.:
71872-7292,71872-7208,71872-7224,71872-7227+13 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-8617 - Precision Dose Inc.:
68094-073 - Preferred Pharmaceuticals, Inc..:
68788-8279,68788-8650 - ProPharma Distribution:
84549-543,84549-205,84549-203,84549-204 - Remedyrepack Inc.:
70518-4597,70518-3031,70518-4671,70518-4537
Recalls
- Jul 16, 2026 · Class II · Fresenius Kabi USA, LLC
Presence of Particulate Matter: Hair was found in product - Jul 14, 2026 · Class II · Precision Dose Inc.
Failed Impurities/Degradation Specifications - Dec 15, 2025 · Class III · Novadoz Pharmaceuticals Llc
Failed Impurities/Degradation Specifications - Jun 6, 2023 · Class III · HF Acquisition Co LLC
Labeling: Label Mix-up - May 18, 2023 · Class III · Aurolife Pharma, LLC
Failed Impurities/Degradation Specifications - Feb 7, 2023 · Class II · Accord Healthcare, Inc. · 4 recall notices
CGMP Deviations: recalling drug products following an FDA inspection. - Dec 22, 2022 · Class II · Avkare Llc
Failed impurities/degradation specifications: Out of specification for unknown impurities. - Dec 16, 2022 · Class II · Aurolife Pharma, LLC
Failed Impurities/Degradation Specifications - Mar 17, 2022 · Class II · Aurolife Pharma, LLC
Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room. - Jan 28, 2021 · Class III · Accord Healthcare, Inc.
Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials - Feb 7, 2020 · Class III · AuroMedics Pharma LLC
Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.