Methylphenidate Hydrochloride ER Tablet 54mg

Methylphenidate HCl ER Tablet 54mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Methylphenidate HCl ER Tablet 5mg
  
• Methylphenidate HCl ER Tablet 10mg
• Methylphenidate HCl ER Tablet 18mg
• Methylphenidate HCl ER Tablet 27mg
• Methylphenidate HCl ER Tablet 36mg
• Methylphenidate HCl ER Tablet 54mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• a) Methylphenidate HCl ER Tablet 5mg
  Each film-coated tablet contains:
  Methylphenidate HCl USP………………5mg
  Colours: Titanium Dioxide
• b) Methylphenidate HCl ER Tablet 10mg
  Each film-coated tablet contains:
  Methylphenidate HCl USP………………10mg
  Colours: Quinoline Yellow
• c) Methylphenidate HCl ER Tablet 18mg
  Each film-coated tablet contains:
  Methylphenidate HCl USP………………18mg
  Colours: Titanium Dioxide Red
• d) Methylphenidate HCl ER Tablet 27mg
  Each film-coated tablet contains:
  Methylphenidate HCl USP………………27mg
  Colours: Quinoline Yellow
• e) Methylphenidate HCl ER Tablet 36mg
  Each film-coated tablet contains:
  Methylphenidate HCl USP………………36mg
  Colours: Indigo carmine
• f) Methylphenidate HCl ER Tablet 54mg
  Each film-coated tablet contains:
  Methylphenidate HCl USP………………54mg
  Colours: Orange 4

THERAPEUTIC INDICATIONS:

• This medication is used to treat attention deficit hyperactivity disorder – ADHD. It works by changing the amounts of certain natural substances in the brain. Methylphenidate belongs to a class of drugs known as stimulants.

CAUTION & WARNING:

• CAUTION:
  Read enclosed leaflet before use.
  Keep medicine out of reach of children.
  SWALLOW WHOLE DO NOT CHEW OR CRUSH
• Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

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 Methylphenidate Hydrochloride ER Tablet 54mg

Methylphenidate Hydrochloride ER Tablet 54mg belongs to a class of medicines called central nervous system stimulants. It is most commonly prescribed for:

• Attention Deficit Hyperactivity Disorder (ADHD) – improves concentration, focus, and impulse control.

• Narcolepsy – reduces excessive daytime sleepiness and sudden sleep attacks.

The medicine works by affecting certain natural chemicals in the brain, particularly dopamine and norepinephrine, which play a key role in controlling attention and behavior.

Global demand for Methylphenidate Hydrochloride ER Tablet 54mg is significantly increasing, driven by a rising prevalence of ADHD in children, adolescents, and adults. According to recent reports, the global ADHD treatment market is projected to exceed USD 18 billion by 2030, creating robust opportunities for manufacturers and exporters like Taj Pharma.

In-depth Details for Importers, Exporters & Buyers

When sourcing Methylphenidate Hydrochloride ER Tablet 54mg from India, global buyers seek assurance of regulatory compliance, stable supply, and competitive pricing. Taj Pharma fulfills these requirements with world-class infrastructure and international certifications.

1. Regulatory Documentation Provided

Taj Pharma offers full regulatory support for easy product registration:

• WHO-GMP Certificate

• EU-GMP Approval (where applicable)

• Certificate of Pharmaceutical Product (COPP)

• Free Sale Certificate (FSC)

• Certificate of Analysis (CoA)

• CTD / eCTD Dossier for submission to health authorities

2. Custom Packaging & Labeling

• Blister packs, strip packs, HDPE bottles, and cartons

• Multilingual labeling (English, French, Spanish, Arabic, Russian, etc.)

• Private labeling and PCD Pharma Franchise opportunities

3. Shelf-life, Storage & Dosage Form

• Shelf-life: 24–36 months

• Storage: Below 30°C, away from direct sunlight and moisture

• Dosage Form: Extended-release (ER) oral tablets

4. Export Certifications

Taj Pharma complies with international quality and safety standards:

• WHO-GMP (World Health Organization)

• EU-GMP (European Union)

• ISO 9001:2015 Quality Management System

• COPP for smooth overseas registrations

• DMF and CTD dossiers available on request

5. Target Countries & Export Markets

Taj Pharma exports Methylphenidate Hydrochloride ER Tablet 54mg to over 40 countries worldwide, including:

• Africa: Nigeria, South Africa, Kenya, Ghana, Ethiopia

• Middle East: UAE, Saudi Arabia, Iraq, Yemen

• Asia: Vietnam, Cambodia, Myanmar, Philippines, Sri Lanka

• CIS: Russia, Uzbekistan, Kazakhstan, Ukraine

• Latin America: Brazil, Peru, Chile, Dominican Republic

• Europe: Poland, Romania, Bulgaria

Why is the Most Trusted Manufacturer, Supplier & Exporter

As a leading Methylphenidate Hydrochloride ER Tablet 54mg Manufacturer in India, Taj Pharma is renowned for quality, affordability, and regulatory compliance.

1. State-of-the-Art Manufacturing

• WHO-GMP & EU-GMP certified plants in Vapi, Gujarat

• Fully automated manufacturing with zero human contamination risk

• Dedicated R&D teams for process optimization and formulation innovation

2. Affordable Pricing & Quality Assurance

• Cost-effective bulk pricing for international tenders and private distributors

• 100% batch testing through in-house QC and third-party accredited labs

• Compliance with pharmacopeial standards (IP/USP/EP/BP)

3. Global Presence & Supply Chain Support

• Exporting to Africa, Latin America, Middle East, Asia, and Europe

• End-to-end logistics and customs clearance support

• Flexible MOQ (Minimum Order Quantity) to support small & large buyers

4. Top 20 Countries Exporting Methylphenidate Hydrochloride ER Tablet 54mg

Nigeria, Kenya, Ghana, Iraq, UAE, Saudi Arabia, Bangladesh, Sri Lanka, Vietnam, Ukraine, Uzbekistan, Colombia, Peru, Ecuador, Philippines, Tanzania, Myanmar, Cambodia, Jordan, Zambia

Technical Product Specification Table

If you are looking for a Methylphenidate Hydrochloride ER Tablet 54mg Manufacturer & Supplier in India, Taj Pharma is your trusted partner.

We offer:
✔ Bulk supply for distributors and hospitals
✔ Contract manufacturing & private labeling
✔ PCD Pharma franchise opportunities

📩 Contact Taj Pharma today to request product samples, quotations, or partnership details. Together, we can ensure affordable access to ADHD and narcolepsy treatments worldwide.

Top 20 FAQs

Q1. What is Methylphenidate Hydrochloride ER Tablet 54mg used for?
A: It is used to treat ADHD and narcolepsy by improving focus, alertness, and behavior control.

Q2. Who is the best Methylphenidate Hydrochloride ER Tablet 54mg Manufacturer in India?
A: Taj Pharma is a top manufacturer and exporter, known for WHO-GMP certified quality.

Q3. Can Methylphenidate ER 54mg be exported from India?
A: Yes, Taj Pharma exports globally with full regulatory support and documentation.

Q4. What is the shelf life of this medicine?
A: Typically 24–36 months.

Q5. What are the common side effects?
A: Headache, insomnia, stomach ache, loss of appetite, and dry mouth.

Q6. How should this medicine be taken?
A: At the same time each day, with or without food. Do not crush or chew the ER tablet.

Q7. Is Methylphenidate ER safe for children?
A: Yes, but dosage should only be prescribed by a pediatric specialist.

Q8. Can it cause addiction?
A: It has a potential for misuse, hence must be taken under medical supervision.

Q9. Does Taj Pharma offer PCD Pharma franchise?
A: Yes, Taj Pharma provides nationwide PCD franchise opportunities.

Q10. Can this medicine be customized for private labeling?
A: Yes, Taj Pharma provides custom branding and packaging.

Q11. Which countries import Methylphenidate ER 54mg from Taj Pharma?
A: Over 40 countries across Africa, Asia, Middle East, Latin America, and CIS.

Q12. What certifications does Taj Pharma have?
A: WHO-GMP, EU-GMP, ISO 9001:2015, and COPP.

Q13. Can Taj Pharma supply for government tenders?
A: Yes, Taj Pharma is an approved supplier for institutional and tender-based procurement.

Q14. What precautions should be taken?
A: Avoid late evening doses to prevent insomnia. Do not consume alcohol.

Q15. Does Methylphenidate affect sleep?
A: Yes, it may cause insomnia. Morning dosing is preferred.

Q16. Can this medicine be stopped suddenly?
A: No, abrupt discontinuation may worsen symptoms. Always taper under medical supervision.

Q17. Is it safe during pregnancy?
A: Not recommended unless prescribed by a doctor.

Q18. Does Taj Pharma provide DMF/CTD dossiers?
A: Yes, complete dossiers are available for product registration.

Q19. Can buyers request product samples?
A: Yes, Taj Pharma provides samples for quality evaluation.

Q20. Why choose Taj Pharma?
A: Because of global trust, WHO-GMP quality, affordability, and unmatched export experience.