Buprenorphine Sublingual Tablet is a specialized Finished Dosage Form (FDF) and a potent partial opioid agonist manufactured by Parand Darou Co. By binding to μ-opioid receptors and exhibiting a distinct “ceiling effect,” Buprenorphine serves as a strategic therapeutic agent for both Opioid Use Disorder (OUD) maintenance/substitution therapy and acute or chronic pain management protocols. The sublingual route of administration ensures optimal capillary absorption, bypassing first-pass hepatic metabolism and providing effective bioavailability.
Therapeutic Dosages, Appearance & Packaging
Buprenorphine sublingual tablets are produced in three standard therapeutic strengths: 0.4 mg, 2 mg, and 8 mg. The tablets are formulated as Round-Biconvex solid dosages to facilitate proper sublingual dissolution. To ensure complete physicochemical stability, the product is supplied in medical-grade blister packs (ALU-PVC), with each carton containing 3 blisters of 10 tablets.
Regulatory Status & Dispensing Guidelines
This product is strictly classified as an under control medicine. Distribution and dispensing are conducted exclusively through validated specialist prescriptions, in full compliance with the rigorous protocols and oversight of the Food and Drug Administration.
General Information
| Generic Name | Buprenorphine Sublingual Tablet | |
| Brand Name | – | |
| Manufacturer | Parand Darou Co. |
Specification
| Dosage Form | Sublingual Tablet | |
| Strength | 0.4 mg, 2 mg, 8 mg | |
| Appearance | Round-Biconvex | |
| Packaging | Each box contains 3 blisters (ALU-PVC) of 10’s | |
| OTC/Prescription/Supplement | Prescription | |
| Route of Administration | Sublingual | |
| Access Level | Under control medicine | |
| Category | Opioid partial agonist (OUD treatment & Pain management) |
