GENERIC NAME OF THE MEDICINAL PRODUCT:
Suvorexant Tablet 10mg
Suvorexant Tablet 15mg
Suvorexant Tablet 20mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each Film coated tablet contains:
Suvorexant …………….5mg
Excipients…………………………….… q.s.
Colour: Red Oxide iron
b) Suvorexant Tablet 10mg
Each Film coated tablet contains:
Suvorexant …………….10mg
Excipients…………………………….… q.s.
Colour: Quinoline Yellow
c) Suvorexant Tablet 15mg
Each Film coated tablet contains:
Suvorexant …………….15mg
Excipients…………………………….… q.s.
Colour: Indigo Carmine
d) Suvorexant Tablet 20mg
Each Film coated tablet contains:
Suvorexant …………….20mg
Excipients…………………………….… q.s.
Colour: Iron Oxide Yellow
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
STORAGE & DOSAGE:
Dosage: As directed by the physician.
Attach dispensing label as per end country.
Suvorexant Tablet 15mg Technical Specification:
| Product Name: | Suvorexant Tablet |
| Brand Name: | Generics |
| Strength: | (5mg), (10mg), (15mg), (20mg) |
| Dosage Form: | Tablet (Film-coated) |
| Route of Administration: | Via oral Route |
| Packing: | 30s, 90s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | CNS Depressant, benzodiazepines |
| Indication: | Suvorexant is used treat insomnia (difficulty falling asleep or staying asleep). Suvorexant is in a class of medications called orexin receptor antagonists. It works by blocking the action of a certain natural substance in the brain that causes wakefulness. |
| Storage: | controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Suvorexant Tablet 5mg
- Suvorexant Tablet 10mg
- Suvorexant Tablet 15mg
- Suvorexant Tablet 20mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- a) Suvorexant Tablet 5mg
Each Film coated tablet contains:
Suvorexant …………….5mg
Excipients…………………………….… q.s.
Colour: Red Oxide iron - b) Suvorexant Tablet 10mg
Each Film coated tablet contains:
Suvorexant …………….10mg
Excipients…………………………….… q.s.
Colour: Quinoline Yellow - c) Suvorexant Tablet 15mg
Each Film coated tablet contains:
Suvorexant …………….15mg
Excipients…………………………….… q.s.
Colour: Indigo Carmine - d) Suvorexant Tablet 20mg
Each Film coated tablet contains:
Suvorexant …………….20mg
Excipients…………………………….… q.s.
Colour: Iron Oxide Yellow
THERAPEUTIC INDICATIONS:
- Suvorexant is used treat insomnia (difficulty falling asleep or staying asleep). Suvorexant is in a class of medications called orexin receptor antagonists. It works by blocking the action of a certain natural substance in the brain that causes wakefulness.
CAUTION & WARNING:
- CAUTION:
Keep medicine out of reach of CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH - Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
STORAGE & DOSAGE:
- Storage: Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture.
- Dosage: As directed by the physician.
Introduction to Suvorexant Tablet 15mg: Uses, Global Demand & Clinical Benefits
Suvorexant Tablet 15mg is a highly effective medication used in the treatment of insomnia—a common sleep disorder affecting millions globally. Suvorexant belongs to a class of drugs known as orexin receptor antagonists (ORAs) or sedative-hypnotics. By selectively blocking orexins, neuropeptides that promote wakefulness, this medication helps individuals fall asleep faster and stay asleep longer, thus improving sleep quality and overall well-being.
As the global population becomes increasingly affected by lifestyle-related sleep disturbances, the demand for scientifically advanced and clinically effective solutions like Suvorexant Tablet 15mg has soared. Countries such as the USA, UK, UAE, Australia, and Japan have reported increased usage of ORAs, with Suvorexant being one of the most prescribed molecules in its class.
Among the top global suppliers, Taj Pharma stands out as the leading Suvorexant Tablet 15mg Manufacturer in India, offering unmatched quality, global regulatory compliance, and export efficiency.
In-Depth Details for Importers, Exporters, and Global Buyers
✅ Regulatory Documentation Provided
Taj Pharma ensures that every export batch of Suvorexant Tablet 15mg is backed by comprehensive documentation for regulatory clearance, including:
-
Certificate of Pharmaceutical Product (COPP)
-
Certificate of Analysis (CoA)
-
Batch Manufacturing Records (BMR)
-
Free Sale Certificates
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WHO-GMP and EU-GMP Compliance Certificates
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CTD Dossiers (Common Technical Document)
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Stability Data & Clinical Trial Reports (on request)
✅ Custom Packaging & Labelling
We provide custom packaging and labeling solutions to suit the specific needs of importing countries and distributors, including:
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Multilingual labeling
-
Tamper-proof blister/bottle packaging
-
Climate-controlled packaging options
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Barcode integration & serialization as per 21 CFR Part 11
✅ Shelf Life, Storage & Dosage Form
-
Dosage Strength: Suvorexant Tablet 15mg
-
Dosage Form: Film-coated oral tablets
-
Shelf Life: 24 months from the date of manufacturing
-
Storage: Store below 30°C in a dry place, away from sunlight
✅ Export Certifications Available
Taj Pharma’s Suvorexant Tablet 15mg is approved for export in regulated and semi-regulated markets with the following certifications:
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WHO-GMP Certified Manufacturing Plant
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EU-GMP Certification for Select Facilities
-
ISO 9001:2015 & ISO 14001:2015
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COFEPRIS, PICS, US FDA (Type II DMF) Ready
-
CTD/ACTD format dossiers available for registration in multiple countries
✅ Target Export Markets
Taj Pharma actively exports Suvorexant Tablet 15mg to over 30 countries, including:
Nigeria, Kenya, Ghana, Iraq, UAE, Saudi Arabia, Bangladesh, Sri Lanka, Vietnam, Ukraine, Uzbekistan, Colombia, Peru, Ecuador, Philippines, Tanzania, Myanmar, Cambodia, Jordan, Zambia
Why is the Most Trusted Manufacturer, Supplier & Exporter
🌟 State-of-the-Art Manufacturing Facility – Vapi, Gujarat
Taj Pharma is a WHO-GMP and EU-GMP approved pharmaceutical manufacturer based in Vapi, Gujarat. Our cutting-edge facility is equipped with:
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Automated production lines
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Class 100,000 cleanrooms
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24×7 quality control monitoring
-
Advanced HPLC and GC instruments
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Zero-contamination policies
🌟 Affordable Pricing & Global Quality Assurance
While Suvorexant Tablet 15mg is a high-end sleep aid, Taj Pharma ensures it remains affordable for global buyers by leveraging:
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In-house API sourcing
-
Scalable production capabilities
-
Stringent QC and QA measures
-
Cost-effective logistics support
🌟 Global Presence & Robust Supply Chain
With a dedicated export team and established logistics network, we offer:
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Seamless international shipping
-
Real-time tracking & delivery
-
Local support for registration & distribution
-
PAN India PCD Pharma Franchise opportunities
🌍 Top 20 Countries Taj Pharma Exports To
| Sr | Country | Regulatory Status |
|---|---|---|
| 1 | USA | FDA Compliance |
| 2 | UK | MHRA Compliance |
| 3 | South Africa | MCC Approved |
| 4 | UAE | MOH Approved |
| 5 | Australia | TGA Registered |
| 6 | Germany | EU-GMP Compliant |
| 7 | Nigeria | NAFDAC Registered |
| 8 | Kenya | PPB Registered |
| 9 | Philippines | FDA Registered |
| 10 | Vietnam | DAV Registered |
| 11 | Myanmar | FDA Certified |
| 12 | Sri Lanka | NMRA Approved |
| 13 | Saudi Arabia | SFDA Compliant |
| 14 | Egypt | CAPA Registered |
| 15 | Brazil | ANVISA Compliant |
| 16 | Mexico | COFEPRIS Compliant |
| 17 | Colombia | INVIMA Registered |
| 18 | Thailand | Thai FDA Approved |
| 19 | Peru | DIGEMID Registered |
| 20 | Canada | Health Canada Compliant |
Technical Specification: Suvorexant Tablet 15mg
| Specification | Details |
|---|---|
| Product Name | Suvorexant Tablet 15mg |
| API | Suvorexant |
| Brand Name | Belsomra Equivalent |
| Therapeutic Class | Sedative-Hypnotic, ORA |
| Form | Film-Coated Tablet |
| Strength | 15mg |
| Packaging Type | Alu-Alu / Blister / Bottle |
| Storage | Below 30°C, Dry Place |
| Shelf Life | 24 Months |
| Manufacturing Site | Vapi, Gujarat – India |
| Certifications | WHO-GMP, EU-GMP, ISO, COPP, CTD |
| Country of Origin | India |
| Schedule Classification | Schedule IV Controlled Substance |
Are you a global importer, government buyer, or PCD distributor searching for a reliable Suvorexant Tablet 15mg Manufacturer in India?
Look no further than Taj Pharma, your trusted pharmaceutical export partner.
📞 Contact Now for Bulk Orders, Franchise Enquiries, or Product Registrations:
🌐 Website: www.tajpharma.com
📧 Email: sales@tajpharma.com | exports@tajpharma.com
📞 Phone: +91-22-2637-4592
Top 20 FAQs
1. What is Suvorexant Tablet 15mg used for?
It is used to treat insomnia by helping individuals fall asleep and stay asleep longer.
2. How does Suvorexant work?
It blocks orexins, brain chemicals that promote wakefulness, helping the body to sleep.
3. Is Suvorexant addictive?
Suvorexant is a Schedule IV controlled substance; hence, it has a low potential for dependence.
4. What are the side effects of Suvorexant?
The most common side effect is sleepiness. Others include next-day drowsiness and coordination issues.
5. How should Suvorexant Tablet 15mg be taken?
Take once daily within 30 minutes of going to bed. Avoid heavy meals before dosing.
6. Can elderly patients take Suvorexant?
Yes, but with caution, as the risk of falls and confusion increases with age.
7. What precautions should I take with this drug?
Avoid driving or operating machinery the day after use. Do not mix with alcohol.
8. Is it safe for patients with liver disease?
Not recommended for those with severe hepatic impairment.
9. Can it be used during pregnancy?
Consult your physician. Suvorexant should be used only if clearly needed.
10. Does Taj Pharma offer international regulatory support?
Yes. Dossiers in CTD format are available along with WHO-GMP, COPP, FSC, and more.
11. What is the shelf life of Suvorexant Tablet 15mg?
24 months under recommended storage conditions.
12. Is Suvorexant better than Z-drugs?
Studies suggest orexin receptor antagonists like Suvorexant may be more effective than Z-drugs.
13. Can I get a PCD franchise for Suvorexant?
Yes. Taj Pharma offers PAN India PCD Pharma Franchise options.
14. Does Taj Pharma provide custom packaging?
Absolutely. We offer multilingual, serialized, and tamper-proof packaging.
15. Is the product registered globally?
Yes. Our products are registered and exported to over 30 countries.
16. What documents are needed for importing?
We provide COPP, COA, FSC, BMR, CTD Dossier, etc.
17. Can I order in small batches?
Yes, we accept MOQ orders depending on the market.
18. What are the logistics options?
We support both sea and air freight with complete shipping documentation.
19. Is Suvorexant Tablet 15mg available in Mumbai?
Yes. Taj Pharma supplies Suvorexant from its Mumbai and Vapi locations.
20. Why should I choose Taj Pharma?
Because we offer top-tier quality, regulatory expertise, affordability, and trusted international partnerships.






