Drug
Who makes alendronate sodium?
16 companies list alendronate sodium as a human prescription drug, including under the names Binosto, FOSAMAX. Forms: solution; tablet; tablet, effervescent. Routes: 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 alendronate sodium
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Amneal Pharmaceuticals of New York, LLCIndia | tablet | ANDAANDA075710 | 5 | 14 |
| International Medication Systems, Ltd.United States | tablet | ANDAANDA076768, ANDA090124 | 4 | 3 |
| Rising Pharma Holdings, Inc.United States | tablet | ANDAANDA090124 | 3 | 1 |
| Northstar Rx, LLC, | tablet | ANDAANDA090124 | 3 | 0 |
| CIPLA PHARMACEUTICALS LIMITEDIndia | tablet | ANDAANDA076768 | 2 | 7 |
| Aurobindo Pharma LimitedIndia | tablet | ANDAANDA090124 | 2 | 6 |
| NuCare Pharmaceuticals,Inc.United States | tablet | ANDAANDA076768 | 2 | 1 |
| RemedyRepack, IncUnited States | tablet | ANDAANDA076768 | 2 | 1 |
| Exelan Pharmaceuticals, Inc. | tablet | ANDAANDA076768 | 2 | 0 |
| Hikma Pharmaceuticals USA Inc.United States | solution | ANDAANDA090520 | 1 | 4 |
| Organon LLCNetherlands | tablet | NDANDA020560 | 1 | 4 |
| ANI Pharmaceuticals, Inc.United States | solution | ANDAANDA214512 | 1 | 1 |
| Hangzhou Minsheng Binjiang Pharmaceutical Co.,Ltd.China | tablet | ANDAANDA090258 | 1 | 1 |
| Preferred Pharmaceuticals Inc.United States | tablet | ANDAANDA076768 | 1 | 1 |
| Proficient Rx LPUnited States | tablet | ANDAANDA090124 | 1 | 1 |
| Radius Health, Inc. | tablet, effervescent | NDANDA202344 | 1 | 0 |
Bulk ingredient listings
- Pharmaceutical Works POLPHARMA · 2 NDC
- Assia Chemical Industries Ltd. - Teva Tech SiteIsrael · 1 NDC
- Aurobindo Pharma LimitedIndia · 1 NDC
- CIPLA PHARMACEUTICALS LIMITEDIndia · 1 NDC
- Cadila Pharmaceuticals LimitedIndia · 1 NDC
- Dr. Reddy's Laboratories LimitedIndia · 1 NDC
- Jubilant Biosys LimitedIndia · 1 NDC
- MINSHENG GROUP SHAOXING PHARMACEUTICAL CO., LTD.China · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
Orange Book patents
1 unexpired patent lists alendronate sodium as the active ingredient, expiring between Dec 2031 and Dec 2031. Application holder: RADIUS HEALTH INC.
Enquiry
Common questions
- Who makes alendronate sodium?
- 16 companies list alendronate sodium as a human prescription drug in the openFDA NDC Directory, led by Amneal Pharmaceuticals of New York, LLC, International Medication Systems, Ltd., Rising Pharma Holdings, Inc., Northstar Rx, LLC,, CIPLA PHARMACEUTICALS LIMITED. 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 Binosto?
- 14 companies list alendronate sodium 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 alendronate sodium active ingredient?
- 9 companies list alendronate sodium as a bulk ingredient, including Pharmaceutical Works POLPHARMA, Assia Chemical Industries Ltd. - Teva Tech Site, Aurobindo Pharma Limited, CIPLA PHARMACEUTICALS LIMITED.