Asenapine Maleate Sublingual Tablets 10mg

Asenapine Maleate Sublingual Tablets 10mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Asenapine Maleate Sublingual Tablets 2.5mg
B) Asenapine Maleate Sublingual Tablets 5mg
C) Asenapine Maleate Sublingual Tablets 10mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Asenapine Maleate Sublingual Tablets IP 2.5mg
Each Sublingual tablet contains:
Asenapine Maleate
Equivalent Asenapine          2.5mg
Excipients                               q.s.

B) Asenapine Maleate Sublingual Tablets IP 5mg
Each Sublingual tablet contains:
Asenapine Maleate
Equivalent Asenapine          5mg
Excipients                               q.s.

C) Asenapine Maleate Sublingual Tablets IP 10mg
Each Sublingual tablet contains:
Asenapine Maleate
Equivalent Asenapine          10mg
Excipients                               q.s.

THERAPEUTIC INDICATIONS:

Asenapine Maleate is used to treat certain mental/mood disorders (such as schizophrenia, bipolar disorder). Asenapine helps you to think more clearly, feel less nervous, and take part in everyday life. It may also help to decrease hallucinations (hearing/seeing things that are not there) and prevent severe mood swings. Asenapine is a psychiatric medication that belongs to the class of drugs called atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain (neurotransmitters).

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Place tablet under tongue and allow it to dissolve completely.
Do not eat or drink for 10 minutes.
Do not crush, chew or swallow tablet.

Warning: To be sold by retail on the prescription of a psychiatrist only.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dosage: As directed by the Physician

Attach dispensing label as per end county.

Introduction to Asenapine Maleate Sublingual Tablets 10mg

What is Asenapine Maleate Sublingual Tablets 10mg?

Asenapine Maleate Sublingual Tablets 10mg are an atypical (second-generation) antipsychotic medication. Unlike conventional oral tablets, this formulation is placed under the tongue to dissolve. Swallowing the tablet makes it largely ineffective due to extensive first-pass metabolism.

Therapeutic Uses

• Treatment of schizophrenia in adults

• Management of bipolar I disorder (mania or mixed episodes)

• Used alone or in combination with lithium or valproate

This medicine should not be used for behavioral problems in elderly patients with dementia, as per clinical safety guidelines.

Global Demand Overview

Rising awareness of mental health, preference for fast-acting sublingual dosage forms, and improved patient compliance have fueled global demand for Asenapine Maleate Sublingual Tablets 10mg export from India. Indian manufacturers like Taj Pharma are preferred worldwide for their WHO-GMP facilities, cost efficiency, and regulatory expertise.

 Trusted Asenapine Maleate Sublingual Tablets 10mg Manufacturer Supplier in India

Taj Pharma Ltd India is a well-recognized Manufacturer, Exporter, and Supplier of Asenapine Maleate Sublingual Tablets 10mg from Vapi, Gujarat, India. The company follows strict quality systems, validated manufacturing processes, and international pharmacopeial standards.

Asenapine works in the brain to rebalance dopamine and serotonin, improving thinking, mood, and behavior in patients with psychotic disorders. Taj Pharma ensures that every batch meets global safety, efficacy, and stability requirements.

  Dosage, Administration & Safety Information

How to Take Asenapine Maleate Sublingual Tablets 10mg

• Comes as a sublingual tablet

• Place the tablet under the tongue and allow it to dissolve completely

• Do not chew, crush, or swallow

• Usually taken twice daily

• Take at the same times each day

• Follow the doctor’s prescription exactly

Eating or drinking immediately after administration should be avoided for a short duration to ensure optimal absorption.

Mechanism of Action

Asenapine is a second-generation antipsychotic (SGA). It modulates dopamine and serotonin receptors, helping stabilize mood, reduce hallucinations, and improve cognitive function in schizophrenia and bipolar disorder.

  In-Depth Information for Importers, Exporters & Global Buyers

Regulatory Documentation Provided

As a professional Asenapine Maleate Sublingual Tablets 10mg Supplier, Taj Pharma provides complete regulatory support, including:

• WHO-GMP Certificate

• Certificate of Pharmaceutical Product (COPP)

• CTD Dossier (Modules 1–5)

• Certificate of Analysis (CoA)

• Stability Study Reports

• Batch Manufacturing Records

Custom Packaging & Labeling

Taj Pharma offers flexible and compliant packaging solutions:

• Alu-Alu and blister packaging

• Bottles for institutional supply

• Multilingual labeling

• Country-specific artwork and inserts

• Private labeling and contract manufacturing

Shelf Life, Storage & Dosage Form

• Dosage Form: Sublingual Tablet

• Strength: 10mg

• Shelf Life: 24–36 months

• Storage: Store below 25°C, protect from moisture and light

Export Certifications

• WHO-GMP certified manufacturing unit

• ISO-compliant quality systems

• EU-GMP support documentation (as required)

• GDP-compliant logistics and cold-chain management where necessary

Target Export Countries & Markets

Taj Pharma exports Asenapine Maleate Sublingual Tablets 10mg from India to:

• Asia

• Africa

• Middle East

• CIS Countries

• Latin America

 Why Taj Pharma is the Most Trusted Asenapine Manufacturer in India

State-of-the-Art Manufacturing

Taj Pharma’s advanced production facilities in Vapi, Gujarat are equipped with modern machinery, controlled environments, and in-process quality monitoring to ensure consistent sublingual tablet performance.

Affordable Pricing with Global Quality

As a leading Asenapine Maleate Sublingual Tablets 10mg Manufacturer & Supplier, Taj Pharma delivers international-quality products at competitive Indian pricing, making it ideal for tenders and bulk procurement.

Global Presence & Reliable Supply Chain

A dedicated export team, regulatory specialists, and efficient logistics network ensure timely delivery, documentation accuracy, and uninterrupted supply.

Top 20 Countries Served by Taj Pharma

Nigeria | Kenya | Ghana | Tanzania | Uganda | Myanmar | Vietnam | Philippines | Yemen | Afghanistan | Iraq | Iran | Peru | Bolivia | Chile | Mexico | Dominican Republic | Nepal | Cambodia |Ethiopia

  Technical Product Specification  

  PAN India Presence & PCD Pharma Franchise Opportunities

Taj Pharma is a:

• Asenapine Maleate Sublingual Tablets 10mg PAN India Manufacturer

• Asenapine Maleate Sublingual Tablets 10mg Manufacturer Supplier and PCD Pharma Franchise

• Asenapine Maleate Sublingual Tablets 10mg Manufacturer from Mumbai

• Asenapine Maleate Sublingual Tablets 10mg Manufacturer in Vapi, Gujarat

PCD franchise partners benefit from monopoly rights, marketing support, visual aids, and consistent supply.

 Top 20 FAQs  

1. What is Asenapine Maleate Sublingual Tablets 10mg used for?
   Schizophrenia and bipolar I disorder.

2. Why is sublingual administration important?
   Swallowing reduces effectiveness.

3. Is Taj Pharma WHO-GMP certified?
   Yes.

4. Does Taj Pharma export globally?
   Yes.

5. Is COPP available?
   Yes.

6. Can it be used with lithium or valproate?
   Yes, as prescribed.

7. Is private labeling available?
   Yes.

8. Where is Taj Pharma located?
   Vapi, Gujarat, India.

9. What is the shelf life?
   24–36 months.

10. Is it suitable for dementia patients?
    No.

11. Are CTD dossiers provided?
    Yes.

12. Is bulk supply available?
    Yes.

13. Is Mumbai supply available?
    Yes.

14. Are stability studies conducted?
    Yes.

15. Is it prescription-only?
    Yes.

16. Does Taj Pharma offer PCD franchise?
    Yes.

17. Are exports to Africa supported?
    Yes.

18. Is pricing competitive?
    Yes.

19. Are batches quality-tested?
    Yes.

20. How can buyers place orders?
    By contacting Taj Pharma directly.

If you are seeking a Leading 1 Asenapine Maleate Sublingual Tablets 10mg Manufacturer & Supplier in India, Taj Pharma is your ideal global partner. With WHO-GMP certification, regulatory expertise, flexible packaging, and reliable exports, Taj Pharma supports your business growth across international markets.

📞 Contact Taj Pharma today to source premium-quality Asenapine Maleate Sublingual Tablets 10mg – Taj Pharma, tailored to your regulatory and commercial needs.