GENERIC NAME OF THE MEDICINAL PRODUCT:
Modafinil Tablets USP 200mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each Un-coated tablets contains:
Modafinil USP …………….50mg
Excipients…………………… q.s.
Colour: Red Oxide iron
b) Modafinil Tablets USP 200mg
Each Un-coated tablets contains:
Modafinil USP …………….200mg
Excipients…………………… q.s.
Colour: Quinoline 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.
Modafinil Tablets 100mg Technical Specification:
| Product Name: | Modafinil Tablets USP |
| Brand Name: | Generics |
| Strength: | (100mg), (200mg) |
| Dosage Form: | Tablets (Un-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: | Modafinil is used to help people who have narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS), or shift work sleep disorder (SWSD) to stay awake during the day. Modafinil does not cure these conditions and will only work as long as you continue to take it. |
| 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:
- Modafinil Tablets USP 100mg
- Modafinil Tablets USP 200mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- a) Modafinil Tablets USP 100mg
Each Un-coated tablet contains:
Modafinil USP …………….50mg
Excipients…………………… q.s.
Colour: Red Oxide iron - b) Modafinil Tablets USP 200mg
Each Un-coated tablet contains:
Modafinil USP …………….200mg
Excipients…………………… q.s.
Colour: Quinoline Yellow
THERAPEUTIC INDICATIONS:
- Modafinil is used to help people who have narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS), or shift work sleep disorder (SWSD) to stay awake during the day. Modafinil does not cure these conditions and will only work as long as you continue to take it.
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.
Why Global Buyers Prefer Modafinil Tablet 100mg from India
The international pharmaceutical industry increasingly relies on Indian manufacturers for high-quality generic medicines. Among the most sought-after products in the sleep disorder segment is Modafinil Tablet 100mg, a prescription medicine used to improve wakefulness and reduce excessive daytime sleepiness.
India has become one of the world’s largest pharmaceutical manufacturing hubs because of its advanced manufacturing infrastructure, skilled workforce, cost-effective production capabilities, and strong regulatory expertise. These advantages allow Indian pharmaceutical companies to produce medicines that meet international quality standards while remaining competitively priced.
For pharmaceutical importers, hospitals, distributors, and government procurement agencies, selecting the right manufacturing partner is critical. Product quality, regulatory compliance, supply reliability, and documentation support directly affect business success and patient safety.
Taj Medico, a trusted Modafinil Tablet 100mg Manufacturer in India, provides comprehensive pharmaceutical solutions designed to meet the needs of global buyers. The company combines advanced manufacturing technology with strict quality control procedures to ensure consistent product performance.
What Importers Should Evaluate Before Purchasing Modafinil Tablet 100mg
Before selecting a supplier, pharmaceutical buyers should consider several important factors:
Manufacturing Compliance
The manufacturing facility should operate according to internationally recognized quality standards such as WHO-GMP and Good Manufacturing Practices (GMP). Compliance demonstrates that products are manufactured consistently and meet required quality specifications.
Product Documentation
Successful importation requires complete documentation. Buyers should verify the availability of:
- Certificate of Pharmaceutical Product (COPP)
- Certificate of Analysis (COA)
- Product Specifications
- Stability Data
- CTD Dossier
- ACTD Dossier
- Manufacturing Licenses
- Free Sale Certificates
These documents support registration and regulatory approvals in importing countries.
Supply Reliability
Many pharmaceutical businesses struggle because of inconsistent product availability. Working with an experienced manufacturer such as Taj Medico helps ensure stable supply chains, timely production schedules, and dependable order fulfillment.
Packaging Flexibility
Different countries have unique packaging and labeling requirements. Taj Medico offers customized packaging solutions that help distributors comply with local regulations while enhancing brand recognition.
Advantages of Partnering with Taj Medico
Taj Medico has established itself as a reliable pharmaceutical exporter by focusing on quality, transparency, and customer support.
Key advantages include:
- WHO-GMP compliant manufacturing
- Competitive export pricing
- Regulatory documentation support
- Custom packaging solutions
- Private label manufacturing
- Dedicated export team
- Bulk supply capabilities
- Long-term distribution partnerships
These advantages make Taj Medico a preferred supplier for buyers seeking a dependable Modafinil Tablet 100mg Supplier from India.
Understanding Modafinil Tablet 100mg for Healthcare Professionals
Modafinil Tablet 100mg belongs to a class of medicines known as wakefulness-promoting agents. It is prescribed for patients experiencing excessive daytime sleepiness due to specific medical conditions.
Common Clinical Uses
Healthcare providers may prescribe Modafinil Tablet 100mg for:
- Narcolepsy
- Obstructive Sleep Apnea (OSA)
- Shift Work Sleep Disorder (SWSD)
The medicine helps patients remain awake and alert during waking hours, thereby improving productivity and daily functioning.
Administration Information
Modafinil Tablet 100mg is generally administered orally and may be taken with or without food according to physician recommendations.
Patients should:
- Take the medicine at the same time each day.
- Follow prescribed dosage instructions.
- Avoid sudden discontinuation without medical advice.
- Inform healthcare providers about any other medications being used.
Safety Considerations
Like all prescription medicines, Modafinil may cause side effects in some individuals.
Common side effects include:
- Headache
- Nausea
- Nervousness
- Anxiety
- Insomnia
- Indigestion
- Runny Nose
Patients should seek medical attention if severe allergic reactions, unusual skin reactions, or significant mood changes occur.
Why Documentation Matters for International Buyers
One of the most common challenges for pharmaceutical importers is obtaining complete registration documentation.
Incomplete documentation can result in:
- Delayed product registrations
- Customs clearance issues
- Regulatory non-compliance
- Increased business costs
Taj Medico provides comprehensive regulatory support to help customers avoid these challenges and accelerate market entry.
Global Export Markets Served by Taj Medico
Taj Medico supplies pharmaceutical products to a wide range of international markets, including:
Africa
- Nigeria
- Kenya
- Ghana
- Tanzania
- Uganda
- Ethiopia
Asia
- Vietnam
- Philippines
- Nepal
- Sri Lanka
- Cambodia
- Myanmar
Middle East
- UAE
- Saudi Arabia
- Oman
- Qatar
- Bahrain
- Kuwait
CIS Countries
- Kazakhstan
- Uzbekistan
- Armenia
- Azerbaijan
Latin America
- Peru
- Bolivia
- Guatemala
- Honduras
This extensive export experience allows Taj Medico to understand market-specific requirements and provide tailored support to international buyers.
Long-Term Business Benefits for Distributors
Distributors partnering with Taj Medico gain access to:
- Consistent product quality
- Competitive pricing structures
- Reliable delivery schedules
- Product registration assistance
- Marketing support opportunities
- Private label solutions
- Franchise opportunities
These benefits help distributors strengthen their market position while maintaining customer confidence.
Top 20 Related FAQs
1. What is Modafinil Tablet 100mg used for?
Modafinil Tablet 100mg is a prescription medicine primarily used to treat excessive daytime sleepiness caused by narcolepsy, obstructive sleep apnea (OSA), and shift work sleep disorder (SWSD). It helps improve wakefulness, alertness, and concentration, enabling patients to remain active during normal waking hours.
2. How does Modafinil Tablet 100mg work?
Modafinil works by influencing certain neurotransmitters in the brain that regulate the sleep-wake cycle. It promotes alertness and wakefulness without causing the intense stimulation associated with some traditional stimulant medications.
3. Who is the leading Modafinil Tablet 100mg Manufacturer in India?
Taj Medico is recognized as a trusted Modafinil Tablet 100mg Manufacturer in India, offering high-quality pharmaceutical products manufactured under stringent quality control standards and supplied to domestic and international markets.
4. Why is India a preferred source for Modafinil Tablet 100mg?
India is known for its advanced pharmaceutical manufacturing infrastructure, skilled workforce, WHO-GMP-compliant facilities, and cost-effective production capabilities. These advantages make India a preferred sourcing destination for pharmaceutical buyers worldwide.
5. Does Taj Medico export Modafinil Tablet 100mg internationally?
Yes. Taj Medico exports Modafinil Tablet 100mg to numerous countries across Africa, Asia, the Middle East, CIS nations, and Latin America, providing complete export documentation and regulatory support.
6. What certifications are available with Modafinil Tablet 100mg exports?
Depending on the importing country’s requirements, certifications may include WHO-GMP, COPP (Certificate of Pharmaceutical Product), Certificate of Analysis (COA), Free Sale Certificate, CTD Dossier, ACTD Dossier, and Stability Data.
7. What dosage strengths of Modafinil are commonly available?
Modafinil is commonly available in 100mg and 200mg tablet strengths. Availability may vary according to regulatory approvals and market requirements.
8. Can Modafinil Tablet 100mg be supplied under a private label?
Yes. Taj Medico offers private labeling and contract manufacturing services, allowing distributors and pharmaceutical companies to market the product under their own brand name.
9. What packaging options are available for export?
Packaging options typically include Alu-Alu blister packs, PVC blister packs, strip packs, HDPE bottles, hospital packs, and customized export packaging with country-specific labeling.
10. What is the shelf life of Modafinil Tablet 100mg?
The product generally has a shelf life of 24 to 36 months when stored under recommended conditions and protected from excessive heat, moisture, and direct sunlight.
11. How should Modafinil Tablet 100mg be stored?
Store the tablets in a cool, dry place below the recommended temperature specified on the packaging. Keep away from moisture, direct sunlight, and out of reach of children.
12. What are the common side effects of Modafinil Tablet 100mg?
Common side effects may include headache, nausea, nervousness, anxiety, insomnia, indigestion, dizziness, back pain, and runny nose. Patients should consult a healthcare professional if symptoms persist.
13. Is Modafinil Tablet 100mg safe for long-term use?
The safety and duration of use should always be determined by a qualified healthcare provider. Patients should follow prescribed treatment plans and attend regular medical evaluations.
14. What regulatory documents does Taj Medico provide to importers?
Taj Medico can provide COA, COPP, Product Specifications, Stability Reports, CTD Dossiers, ACTD Dossiers, Manufacturing Licenses, and other registration documents required by regulatory authorities.
15. Which countries commonly import Modafinil Tablet 100mg from India?
Major importing countries include Nigeria, Kenya, Ghana, UAE, Saudi Arabia, Vietnam, Philippines, Sri Lanka, Nepal, Kazakhstan, Uzbekistan, Peru, and several other emerging pharmaceutical markets.
16. Why do pharmaceutical distributors choose Taj Medico?
Distributors choose Taj Medico because of its consistent product quality, competitive pricing, reliable supply chain, regulatory support, customized packaging options, and strong export experience.
17. Can hospitals and government agencies purchase Modafinil Tablet 100mg in bulk?
Yes. Taj Medico supports bulk orders for hospitals, government procurement agencies, pharmaceutical wholesalers, and healthcare institutions, subject to applicable regulations.
18. What quality control measures are followed during manufacturing?
The manufacturing process includes raw material testing, in-process quality checks, finished product analysis, stability studies, and strict adherence to Good Manufacturing Practices (GMP).
19. How can a distributor become a partner of Taj Medico?
Interested distributors can contact Taj Medico’s export team to discuss distribution opportunities, private labeling requirements, product registration support, and long-term supply agreements.
20. Why should buyers choose a WHO-GMP Manufacturer in India?
A WHO-GMP manufacturer follows internationally recognized quality standards that help ensure product safety, consistency, efficacy, and regulatory compliance. This provides confidence to importers, healthcare professionals, and patients worldwide.
For importers, distributors, hospitals, and procurement agencies seeking a trusted Modafinil Tablet 100mg Manufacturer in India, Taj Medico offers a complete pharmaceutical sourcing solution. Through advanced manufacturing facilities, regulatory expertise, export experience, and customer-focused services, the company continues to build long-term relationships with pharmaceutical buyers worldwide.
Whether the requirement is bulk purchasing, private labeling, contract manufacturing, or long-term distribution partnerships, Taj Medico remains committed to delivering quality, compliance, and reliability in every order.






