Suvorexant Tablet 20mg FDA Manufacturers India, GMP Supplier

Suvorexant Tablet 20mg 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 20mg: Usage, Medical Significance & Global Demand

Suvorexant Tablet 20mg is a powerful prescription medication developed for the treatment of insomnia, a condition characterized by difficulty in falling asleep or staying asleep throughout the night. Suvorexant, marketed under the brand name Belsomra, belongs to the orexin receptor antagonist (ORA) class of drugs. By targeting and blocking the action of orexins—neuropeptides responsible for promoting wakefulness—Suvorexant helps regulate the body’s sleep-wake cycle, enabling better rest and sleep quality.

As modern lifestyles continue to disrupt circadian rhythms globally, the prevalence of sleep disorders like insomnia has increased substantially. Consequently, Suvorexant Tablet 20mg has seen a surge in demand across international markets such as the USA, Canada, UK, Australia, and Southeast Asia.

Taj Pharma, a leading Suvorexant Tablet 20mg Manufacturer in India, provides this high-purity medication in compliance with the highest international regulatory standards, catering to both regulated and semi-regulated markets.

Comprehensive Guide for Importers, Exporters & Global Buyers

📄 Regulatory Documentation Provided

Taj Pharma ensures every Suvorexant Tablet 20mg batch is export-ready with full documentation, including:

Certificate of Pharmaceutical Product (COPP)
WHO-GMP / EU-GMP certificates
Certificate of Analysis (CoA)
Batch Manufacturing Records (BMR)
Stability Data (long-term and accelerated)
CTD/ACTD Dossiers for registration
Free Sale Certificate (FSC)
MSDS (Material Safety Data Sheet)

🎁 Custom Packaging & Labelling Services

We provide customized solutions to meet the specific branding and regulatory requirements of each country:

Multilingual labeling
Serialization & QR-coded packaging
Alu-Alu, blister packs, or HDPE bottle options
Cold-chain or ambient packaging as per API sensitivity
Child-resistant closures & tamper-evident seals

⏳ Shelf Life, Storage & Dosage Form

Form: Oral Film-Coated Tablets
Strength: Suvorexant 20mg
Packaging: Blister / Bottle Pack
Storage: Below 30°C in a dry place
Shelf Life: 24 Months
Route of Administration: Oral

🌍 Certifications Available for Export

Taj Pharma ensures its manufacturing and quality assurance processes are recognized globally:

WHO-GMP Certified Facility
EU-GMP for select export markets
ISO 9001:2015 & ISO 14001:2015 Certified
CTD/ACTD Dossier Ready
Compliance with ICH Q7 and cGMP Standards
COFEPRIS, ANVISA, and INVIMA registration support

🌎 Target Countries & Export Markets

Taj Pharma exports Suvorexant Tablet 20mg to over 40 countries across:

North America (USA, Canada)
Latin America (Mexico, Brazil, Colombia)
Europe (UK, Germany, Poland)
Asia (Vietnam, Myanmar, Philippines, Sri Lanka)
Africa (Nigeria, Kenya, South Africa)
MENA (UAE, Saudi Arabia, Egypt)

Why Taj Pharma is the #1 Trusted Manufacturer & Exporter of Suvorexant Tablet 20mg

🏭 State-of-the-Art WHO-GMP Manufacturing – Vapi, Gujarat

Taj Pharma’s manufacturing plant, located in Vapi, Gujarat, is equipped with:

Automated tablet compression & coating lines
Class 100,000 cleanrooms
Online particle monitoring systems
High-end analytical instruments (HPLC, GC, FTIR)
Zero Cross-contamination protocols

💰 Affordable Pricing with Global Quality Standards

Taj Pharma ensures that Suvorexant Tablet 20mg remains cost-effective while maintaining premium quality. This is achieved through:

In-house API synthesis
Lean manufacturing practices
Scalable production volumes
Bulk procurement of raw materials

🌐 Global Distribution & Supply Chain Support

Seamless export documentation and logistics
On-time air and sea shipments with real-time tracking
Technical support for market authorization and registration
PCD pharma franchise and third-party manufacturing services across India

🌍 Top 20 Exporting Countries

Country	Regulatory Compliance
USA	USFDA Compliant
Canada	Health Canada Approved
UK	MHRA Compliant
Australia	TGA Registered
Germany	EU-GMP Compliant
Mexico	COFEPRIS Registered
Brazil	ANVISA Compliant
Nigeria	NAFDAC Approved
Philippines	FDA Registered
Vietnam	DAV Registered
Kenya	PPB Certified
UAE	MOH Approved
Saudi Arabia	SFDA Compliant
South Africa	MCC Registered
Egypt	CAPA Licensed
Myanmar	FDA Certified
Thailand	Thai FDA Approved
Peru	DIGEMID Compliant
Sri Lanka	NMRA Registered
Colombia	INVIMA Compliant

📋 Technical Product Specification Table

Attribute	Details
Product Name	Suvorexant Tablet 20mg
API	Suvorexant
Brand Reference	Belsomra
Therapeutic Class	Orexin Receptor Antagonist
Formulation	Film-Coated Tablet
Strength	20mg
Route	Oral
Packaging Type	Blister / Bottle Pack
Storage Conditions	Below 30°C
Shelf Life	24 Months
Manufacturer Location	Vapi, Gujarat, India
Certifications	WHO-GMP, EU-GMP, ISO
Compliance	CTD Dossier, COPP, FSC
Minimum Order Quantity (MOQ)	100,000 Tablets

Looking for a reliable Suvorexant Tablet 20mg Manufacturer Supplier in India?
Partner with Taj Pharma, the trusted name in pharmaceutical exports, with unmatched experience, quality, and regulatory support.

📧 Email: exports@tajpharma.com
🌐 Website: www.tajpharma.com
📞 Phone: +91-22-2637-4592
📍 Headquarters: Vapi, Gujarat & Mumbai, Maharashtra – India

Explore PCD pharma franchise opportunities and bulk export deals with the leading WHO-GMP Suvorexant manufacturer India.

❓ Top 20 FAQs

1. What is Suvorexant Tablet 20mg used for?

It treats insomnia, helping people fall asleep and stay asleep longer.

2. How does it work?

Suvorexant blocks orexins, which are brain chemicals that promote wakefulness.

3. Is Suvorexant 20mg the highest dose?

Yes, 20mg is the maximum recommended dose taken once per night.

4. Is this a controlled substance?

Yes, it is classified as a Schedule IV controlled substance.

5. Can it be taken long-term?

It is typically recommended for short-term use (1–2 weeks) only.

6. Is a prescription required?

Yes, it is available only with a doctor’s prescription.

7. Are there any side effects?

Common side effects include drowsiness, dizziness, and fatigue.

8. Is Suvorexant better than Z-drugs?

Some studies show orexin antagonists like Suvorexant are more effective.

9. Does Taj Pharma export Suvorexant globally?

Yes, Taj Pharma exports to over 40 countries.

10. What documentation is provided for export?

COPP, CTD dossier, FSC, CoA, BMR, and more.

11. Can the packaging be customized?

Yes, multilingual and serialized packaging is available.

12. Is it available for PCD franchise?

Yes. Taj Pharma offers PAN India PCD Pharma Franchise.

13. What are the storage requirements?

Store below 30°C in a dry and dark place.

14. Does Taj Pharma have WHO-GMP certification?

Yes. The Vapi plant is WHO-GMP certified.

15. Are CTD/ACTD dossiers available?

Yes, ready-to-submit CTD dossiers are provided.

16. Is there a generic version of Belsomra?

No, Suvorexant is a branded formulation with no generic equivalent currently.

17. What’s the shelf life?

24 months under ideal storage conditions.

18. Can Taj Pharma handle small orders?

Yes, with MOQ starting from 100,000 tablets.

19. Does Taj Pharma assist with product registration?

Absolutely. Full regulatory support is available.

20. How to place an order?

Email info@tajpharma.com or call +91 74 0000 9975 for a quote