Alendronic acid
Sold as Boniran, Ran-alendronate, Femax, Osteonate, Aldren, Zydus alendronate, Fosadron, Accord-alendronate, Ostena, DYNA alendronate, Densate, Ossadura, Gensof, Natrebon once weekly, Osteobon, Fosagen, Merck-alendronate, Alendronate oethmaan, Densalen
(4-Amino-1-hydroxy-1-phosphonobutyl)phosphonic acid
Drag to rotate. Structure from PubChem CID 2088.
Background
Registration
- Applicants
- 15
- Registrations
- 24
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| MSQ Pharma (Pty) Ltd | Boniran, Ran-alendronate | 10, 70 | 410431, 410432, 410433, 410434 | S3 | None |
| Elle pharmCertificate held by Astral Pharma (Pty) Ltd | Femax | 70 mg | 420221 | S3 | PIPIL |
| Pharma Dynamics (Pty) Ltd | Osteonate | 70 mg | 420235 | S3 | PIPIL |
| Zydus Healthcare (Pty) LtdCancelled | Aldren, Zydus alendronate | 70 | 420236, 420276 | S3 | None |
| Innovata pharmaceuticals | Fosadron | Not stated | 420410 | S3 | None |
| Accord Healthcare (Pty) Ltd | Accord-alendronate, Ostena | 10, 70 | 421014, 421015, 421016 | S3 | None |
| Unicorn Pharmaceuticals (Pty) Ltd | DYNA alendronate | 70 mg | 430266 | S3 | None |
| Novagen Pharma (Pty) Ltd | Densate | 70 mg | 450581 | S3 | None |
| Aurogen South Africa (Pty) Ltd | Ossadura, Gensof | 10 mg, 70 mg | 450582, 450583, 450584, 450585 | S3 | None |
| Austell Pharmaceuticals (Pty) LtdCancelled | Natrebon once weekly | 70 mg | 510129 | S3 | None |
| Cipla Medpro (Pty) Ltd | Osteobon | 70 | A390396 | S3 | None |
| Viatris Healthcare (Pty) Ltd | Fosagen | 70 mg | A390597 | S3 | None |
| Merck Generics Rsa (Pty) Ltd | Merck-alendronate | 70 mg | A390598 | S3 | None |
| Oethmaan Biosims (Pty) Ltd | Alendronate oethmaan | 70 | A400514 | S3 | None |
| Trinity Pharma (Pty) Ltd | Densalen | 70 | A400515 | S3 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Boniran 10 EACH TABLET CONTAINS ALENDRONATE SODIUM EQUIVALENT TO ALENDRONIC ACID 10,0 mg | 10 | 41043141/3.2/0431 | Registered | S3 | None |
| Boniran 70 EACH TABLET CONTAINS ALENDRONATE SODIUM EQUIVALENT TO ALENDRONIC ACID 70,0 mg | 70 | 41043241/3.2/0432 | Registered | S3 | None |
| Ran-alendronate 10 EACH TABLET CONTAINS ALENDRONATE SODIUM EQUIVALENT TO ALENDRONIC ACID 10,0 mg | 10 | 41043341/3.2/0433 | Registered | S3 | None |
| Ran-alendronate 70 EACH TABLET CONTAINS ALENDRONATE SODIUM EQUIVALENT TO ALENDRONIC ACID 70,0 mg | 70 | 41043441/3.2/0434 | Registered | S3 | None |
| Femax 70 EACH TABLET CONTAINS ALENDRONATE SODIUM EQUIVALENT TO ALENDRONIC ACID 70,0 mg | 70 mgTablets | 42022142/3.2/0221Approved 21 November 2022 | Registered | S3 | PIPIL |
| Osteonate 70 MG EACH TABLET CONTAINS ALENDRONATE SODIUM EQUIVALENT TO ALENDRONIC ACID 70,0 mg | 70 mgTablets | 42023542/3.2/0235Approved 20 July 2025 | Registered | S3 | PIPIL |
| Aldren 70 tablets EACH TABLET CONTAINS ALENDRONATE SODIUM EQUIVALENT TO ALENDRONIC ACID 70,0 mg | 70Tablets | 42023642/3.2/0236 | Cancelled | S3 | None |
| Zydus alendronate 70 tablets EACH TABLET CONTAINS ALENDRONATE SODIUM EQUIVALENT TO ALENDRONIC ACID 70,0 mg | 70Tablets | 42027642/3.2/0276 | Cancelled | S3 | None |
| Fosadron EACH TABLET CONTAINS ALENDRONATE SODIUM EQUIVALENT TO ALENDRONIC ACID 70,0 mg | Not listed | 42041042/3.2/0410 | Registered | S3 | None |
| Accord-alendronate 70 EACH TABLET CONTAINBS ALENDRONATE SODIUM EQUIVALENT TO ALENDRONIC ACID 70,0 mg | 70 | 42101442/3.2/1014 | Registered | S3 | None |
| Ostena 10 EACH TABLET CONTAIN : ALENDRONATE SODIUM EQUIVALENT TO ALENDRONIC ACID 10,0 mg | 10 | 42101542/3.2/1015 | Registered | S3 | None |
| Ostena 70 EACH TABLET CONTAINBS ALENDRONATE SODIUM EQUIVALENT TO ALENDRONIC ACID 70,0 mg | 70 | 42101642/3.2/1016 | Registered | S3 | None |
| DYNA alendronate 70 MG EACH TABLET CONTAINS ALENDRONATE SODIUM EQUIVALENT TO ALENDRONIC ACID 70,0 mg | 70 mg | 43026643/3.2/0266 | Registered | S3 | None |
| Densate 70 MG EACH TABLET CONTAINS ALENDRONATE SODIUM EQUIVALENT TO ALENDRONIC ACID 70,0 mg | 70 mg | 45058145/3.2/0581 | Registered | S3 | None |
| Ossadura 10 MG EACH TABLET CONTAINS ALENDRONATE SODIUM EQUIVALENT TO ALENDRONIC ACID 10,0 mg | 10 mg | 45058245/3.2/0582 | Registered | S3 | None |
| Ossadura 70 MG EACH TABLET CONTAINS ALENDRONATE SODIUM EQUIVALENT TO ALENDRONIC ACID 70,0 mg | 70 mg | 45058345/3.2/0583 | Registered | S3 | None |
| Gensof 10 MG EACH TABLET CONTAINS ALENDRONATE SODIUM EQUIVALENT TO ALENDRONIC ACID 10,0 mg | 10 mg | 45058445/3.2/0584 | Registered | S3 | None |
| Gensof 70 MG EACH TABLET CONTAINS ALENDRONATE SODIUM EQUIVALENT TO ALENDRONIC ACID 70,0 mg | 70 mg | 45058545/3.2/0585 | Registered | S3 | None |
| Natrebon once weekly 70 MG EACH TABLET CONTAINS ALENDRONATE SODIUM EQUIVALENT TO ALENDRONIC ACID 70,0 mg | 70 mg | 51012951/3.2/0129 | Cancelled | S3 | None |
| Osteobon 70 EACH TABLET CONTAINS ALENDRONATE SODIUM EQUIVALENT TO ALENDRONIC ACID 70,0 mg | 70 | A390396A39/3.2/0396 | Registered | S3 | None |
| Fosagen 70 MG EACH TABLET CONTAINS ALENDRONATE SODIUM EQUIVALENT TO ALENDRONIC ACID 70,0 mg | 70 mg | A390597A39/3.2/0597 | Registered | S3 | None |
| Merck-alendronate 70 MG EACH TABLET CONTAINS ALENDRONATE SODIUM EQUIVALENT TO ALENDRONIC ACID 70,0 mg | 70 mg | A390598A39/3.2/0598 | Registered | S3 | None |
| Alendronate 70 oethmaan EACH TABLET CONTAINS ALENDRONATE SODIUM EQUIVALENT TO ALENDRONIC ACID 70,0 mg | 70 | A400514A40/3.2/0514 | Registered | S3 | None |
| Densalen 70 EACH TABLET CONTAINS ALENDRONATE SODIUM EQUIVALENT TO ALENDRONIC ACID 70,0 mg | 70 | A400515A40/3.2/0515 | Registered | S3 | None |
Regulatory status
Where S3 sits on the scale
Needs a doctor's prescription, dispensed by a pharmacist.
Schedule 3 medicines can only be sold on a prescription from an authorised prescriber, such as a doctor or dentist. A pharmacist dispenses the medicine once they have the written prescription, or a verbal instruction from a prescriber they know. Its price, name, pack size and strength can still be told to the public, as long as nothing links it to what it treats.
Schedule S3, matched to the Consolidated Schedules by ingredient, confidence high.
Who may supply: A pharmacist dispensing against a written or verbal prescription from an authorised prescriber; a veterinarian, who may also prescribe, compound or dispense it directly; a medical practitioner or dentist, who may prescribe it and may compound or dispense it directly only if licensed under section 22C(1)(a); manufacturers and wholesalers may supply people who may lawfully possess it; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.
Consolidated Schedules listings for Alendronate sodium equivalent to alendronic acid
S3: Alendronic acid
Consolidated Schedules 06 July 2026, line 3126
Pharmacological class: Non-hormonal preparations. (class 3.2)
This is an informational summary of the Medicines and Related Substances Act 101 of 1965 and its 2017 General Regulations. It is not medical advice and not legal advice. Always check the medicine's label, which carries the schedule number inside a square border, or ask a pharmacist if you are unsure.
SAHPRA documents
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.