Composition: Modafinil BP 100 mg; excipients q.s.
Dosage form: Uncoated tablet
Usage: Excessive sleepiness associated with selected sleep disorders
Category: Generic Drugs and Medicine
Therapeutic category: Wakefulness-Promoting Agent / CNS Drug
SKU: Modafinil Tablets
Categories: Pharmaceutical Exporter India, Pharmaceutical Formulations India, WHO GMP Certified Formulations
Prescription medicine: Subject to applicable national restrictions.
Modafinil Tablets USP is listed in our pharmaceutical product portfolio for business-to-business enquiries. Product-specific formulation details, available strengths, dosage form, pack configuration and supply terms should be confirmed against the current product specification before ordering.
For distributor, wholesaler, hospital procurement and export enquiries, please request the applicable product specifications, batch documentation, shelf-life information, packaging options and regulatory documents. Availability and documentation depend on the product and destination market.
Manufacturer identified in supplied content: Healthy Life Pharma Pvt. Ltd. (WHO-GMP status requires verification)
Exporter identified in supplied content: Healthy Inc (Star Export House status requires verification)
Modafinil is a prescription wakefulness-promoting agent used to improve wakefulness in adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA) and shift work disorder (SWD), subject to local regulatory approvals. In OSA, it addresses residual sleepiness and does not treat the airway obstruction or replace CPAP or other primary therapy.
The supplied product label specifies an uncoated tablet containing Modafinil BP 100 mg, although the heading describes “Tablets USP.” Healthy Life Pharma Pvt. Ltd. and Healthy Inc are identified as manufacturer and exporter in the supplied material; certification and export authorizations must be verified. This is not an approved general-purpose study aid or cognitive enhancer.
| Product name | Modafinil Tablets |
|---|---|
| Confirmed strength | 100 mg per tablet |
| Composition | Modafinil BP 100 mg; excipients q.s. |
| Dosage form | Uncoated oral tablet |
| Pharmacopoeial labeling | Product heading says USP; ingredient specification says BP. Confirm applicable finished-product standard before publication. |
| Additional 200 mg strength | Referenced in marketing description only; no 200 mg finished-product composition supplied |
| CAS number | 68693-11-8 |
| Therapeutic class | Wakefulness-promoting agent / CNS medicine |
| Indications | Excessive sleepiness associated with narcolepsy, OSA or shift work disorder, where approved |
| Packaging / shelf life | To be verified against registered specifications and stability data |
| SKU | Modafinil Tablets |
Modafinil has low aqueous solubility, so particle-size distribution, dissolution and blend uniformity may be important formulation attributes. Micronization, air-jet milling, direct compression, specific disintegration times and any particular production suite are not verified by the supplied label and should not be represented as established facility practices without manufacturing records.
Manufacturing controls should address cross-contamination prevention, traceability, content uniformity and the registered process.
Finished-product testing should follow the approved applicable monograph and registered specification, including identity, assay, content uniformity, dissolution, impurities and stability. Universal claims such as “>80% dissolution in 30 minutes,” fixed assay limits and a 36-month shelf life cannot be confirmed from the information supplied.
Any GMP certificates, batch certificates of analysis, import permissions and controlled-drug authorizations must be current and market-specific.
Modafinil promotes wakefulness through mechanisms that are not fully understood; dopamine transporter inhibition contributes to its effects. Its clinical use should be based on a confirmed sleep-disorder diagnosis and an individualized assessment of benefit and risk.
Indications in some jurisdictions include excessive sleepiness related to narcolepsy, OSA and shift work disorder. It is not a substitute for adequate sleep or for treatment of the underlying airway obstruction in OSA. Claims of “clean energy,” no rebound effects or safe cognitive enhancement in healthy people are not established.
International distribution requires verification of product registration, applicable scheduling or controlled-substance rules, export and import permits, prescribing status and destination-country requirements. Availability of CTD/ACTD dossiers, COPP, FSC, COA, WHO-GMP certification, and Healthy Inc export-house credentials must be checked before commercial use.
Do not assume that a product authorized in one country can be freely exported to the USA, UK, Australia or Europe.
Q: What strength is confirmed?
A: The supplied tablet composition confirms 100 mg. The 200 mg strength is mentioned only in descriptive text.
Q: Is modafinil a nootropic for studying?
A: It is a prescription medicine for specific sleep-related indications, not an approved study-performance product.
Q: Does modafinil have dependence or misuse potential?
A: Yes. It has abuse and dependence potential and is regulated differently across jurisdictions.
Q: Can it affect contraception?
A: Yes. It can reduce the effectiveness of steroidal hormonal contraceptives during treatment and for a period after stopping; follow the approved local label and discuss alternative or additional contraception with a clinician.
Use only as prescribed and in accordance with the locally approved label. Dose and timing differ by indication, patient factors and liver function. The supplied product is a 100 mg tablet; do not infer a particular daily dose from a separate 200 mg marketing description. Severe hepatic impairment may require dose reduction. Do not exceed the prescribed dose or use to compensate for insufficient sleep.
Serious skin and hypersensitivity reactions: Rare but potentially life-threatening reactions, including Stevens–Johnson syndrome, toxic epidermal necrolysis and DRESS, have been reported. Stop the drug and seek urgent medical advice for a new rash, mouth sores, facial swelling or other hypersensitivity symptoms.
Psychiatric and cardiovascular effects: Anxiety, insomnia, agitation, mood changes, hallucinations, increases in blood pressure or heart rate may occur. Assess relevant psychiatric or cardiac history. Headache, nausea and nervousness are possible.
Drug interactions: Modafinil can interact with hormonal contraceptives and other medicines via drug-metabolizing enzymes. Pregnancy exposure may carry fetal risk; discuss pregnancy planning and contraception with a qualified clinician. It may impair judgment or driving despite perceived wakefulness.
Store according to the approved product label, protected from inappropriate heat and moisture, and keep out of reach of children. The proposed “below 25°C” storage condition and 36-month shelf life need confirmation from product-specific stability and registration records.