Asenapine Maleate Sublingual Tablets 2.5mg

Asenapine Maleate Sublingual Tablets 2.5mg 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 2.5mg

What is Asenapine Maleate Sublingual Tablets 2.5mg?

Asenapine Maleate Sublingual Tablets 2.5mg are an atypical (second-generation) antipsychotic medicine. Unlike conventional oral tablets, this formulation is placed under the tongue to dissolve. Swallowing the tablet makes it largely ineffective due to first-pass metabolism, which is why sublingual use is essential.

Therapeutic Uses

• Treatment of schizophrenia in adults

• Management of bipolar I disorder, including manic and mixed episodes

• Used alone or in combination with lithium or valproate

This medicine should not be used to manage behavioral problems in elderly patients with dementia.

Global Demand and Market Trends

The demand for Asenapine Maleate Sublingual Tablets 2.5mg export from India is rising due to:

• Increasing diagnosis of psychotic disorders

• Preference for low-dose and titration-friendly strengths

• Growing adoption of sublingual dosage forms

• India’s reputation as a reliable WHO-GMP pharmaceutical manufacturing hub

  Trusted Asenapine Maleate Sublingual Tablets 2.5mg Manufacturer Supplier in India

Taj Pharma Ltd India is a well-recognized Manufacturer, Exporter, and Supplier of Asenapine Maleate Sublingual Tablets 2.5mg from Vapi, Gujarat, India. The company follows international quality systems, validated manufacturing processes, and comprehensive in-house testing to ensure uniformity and performance of sublingual tablets.

Asenapine works by rebalancing dopamine and serotonin activity in the brain, helping improve mood, thinking, and behavior in patients with schizophrenia and bipolar disorder.

  Dosage, Administration & Pharmacological Action

Dosage and Administration

• Dosage Form: Sublingual tablet

• Strength: 2.5mg

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

• Do not chew, crush, or swallow

• Usually taken twice daily

• Take at the same time each day as prescribed

Patients should avoid eating or drinking immediately after administration to ensure optimal absorption.

Mechanism of Action

Asenapine is classified as a second-generation antipsychotic (SGA). It modulates dopamine and serotonin receptors, which helps stabilize mood, reduce hallucinations and delusions, and improve overall cognitive and emotional functioning.

  In-Depth Details for Importers, Exporters & Global Buyers

Regulatory Documentation Provided

As a professional Asenapine Maleate Sublingual Tablets 2.5mg Supplier, Taj Pharma provides complete regulatory and compliance documentation, including:

• WHO-GMP Certificate

• Certificate of Pharmaceutical Product (COPP)

• CTD Dossier (Modules 1–5)

• Certificate of Analysis (CoA)

• Stability Data & Validation Reports

• Batch Manufacturing Records

Custom Packaging & Labeling

Taj Pharma offers flexible, export-oriented packaging solutions:

• Alu-Alu blister packs

• PVC/PVDC blister packs

• HDPE bottle packaging

• Country-specific labeling and inserts

• Multilingual artwork

• Private label and contract manufacturing services

Shelf Life, Storage & Dosage Form

• Dosage Form: Sublingual Tablet

• Strength: 2.5mg

• Shelf Life: 24–36 months

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

Export Certifications

• WHO-GMP certified manufacturing facility

• ISO-compliant quality management systems

• EU-GMP supportive documentation (as required)

• GDP-compliant logistics and export handling

Target Export Countries & Markets

Taj Pharma exports Asenapine Maleate Sublingual Tablets 2.5mg from India to:

• Asia-Pacific countries

• African nations

• Middle East

• CIS and Eurasian markets

• Latin America

 Why Taj Pharma is the Most Trusted Asenapine Manufacturer in India

State-of-the-Art Manufacturing Facilities

Taj Pharma’s advanced manufacturing units in Vapi, Gujarat are equipped with:

• Modern sublingual tablet compression technology

• Controlled environmental conditions

• In-process quality monitoring

• Stringent microbial and stability testing

Affordable Pricing with Assured Quality

As a leading Asenapine Maleate Sublingual Tablets 2.5mg Manufacturer & Supplier, Taj Pharma delivers cost-effective solutions without compromising quality, making it ideal for institutional buyers, tenders, and distributors.

Global Presence & Strong Supply Chain

With a dedicated export team, regulatory experts, and reliable logistics partners, Taj Pharma ensures:

• Timely deliveries

• Complete documentation

• Consistent batch-to-batch quality

Top 20 Countries Served by Taj Pharma

India | Vietnam | UAE | Saudi Arabia | Kenya | Tanzania | Nigeria | Philippines | Cambodia | Ghana | Peru | Colombia | Uzbekistan | Kazakhstan | Sri Lanka | Myanmar | Yemen | Oman | South Africa | Chile

 Technical Product Specification 

 PAN India Presence & PCD Pharma Franchise Opportunities

Taj Pharma is a:

• Asenapine Maleate Sublingual Tablets 2.5mg PAN India Manufacturer

• Asenapine Maleate Sublingual Tablets 2.5mg Manufacturer Supplier and PCD Pharma Franchise

• Asenapine Maleate Sublingual Tablets 2.5mg Manufacturer from Mumbai

• Asenapine Maleate Sublingual Tablets 2.5mg Manufacturer in Vapi, Gujarat

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

 Top 20 FAQs  

1. What is Asenapine Maleate Sublingual Tablets 2.5mg used for?
   Schizophrenia and bipolar I disorder.

2. Why must the tablet be taken sublingually?
   Swallowing reduces its 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 combined with lithium or valproate?
   Yes, if 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 elderly dementia patients?
    No.

11. Are CTD dossiers available?
    Yes.

12. Is bulk supply possible?
    Yes.

13. Is Mumbai distribution available?
    Yes.

14. Are stability studies conducted?
    Yes.

15. Is it prescription-only?
    Yes.

16. Does Taj Pharma offer PCD franchise?
    Yes.

17. Are African markets supported?
    Yes.

18. Is pricing competitive for tenders?
    Yes.

19. Are batches quality tested?
    Yes.

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

If you are looking for a Leading 1 Asenapine Maleate Sublingual Tablets 2.5mg Manufacturer & Supplier in India, Taj Pharma is your trusted global partner. With WHO-GMP certification, regulatory expertise, flexible packaging, and dependable exports, Taj Pharma supports your success in regulated and semi-regulated markets worldwide.

📞 Contact Taj Pharma today to source premium-quality Asenapine Maleate Sublingual Tablets 2.5mg – Taj Pharma, tailored to your market and regulatory requirements.