Etizolam & Escitalopram Oxalate Tablets (0.5mg+10mg)

Etizolam & Escitalopram Oxalate Tablets (0.5mg+10mg) Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Etizolam & Escitalopram Oxalate Tablets (0.5mg+10mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Etizolam & Escitalopram Oxalate Tablets (0.5mg+10mg)
  Each film coated tablet contains:
  Etizolam………………………………………………0.5mg
  Escitalopram Oxalate IP
  Equivalent to Escitalopram…………………………..10mg
  Excipients…………………………………………..…q.s
  Colour: Sunset Yellow FCF

THERAPEUTIC INDICATIONS:

Escitalopram Oxalate is a selective serotonin reuptake inhibitor (SSRI) antidepressant. It works by increasing the levels of serotonin, a chemical messenger in the brain. This improves mood and physical symptoms of depression and also relieves symptoms of anxiety, panic attacks and obsessive-compulsive disorders.

CAUTION & SCHEDULE:

CAUTION:  Read enclosed leaflet before use.
Keep medicine out of reach of children.
Tablet to be swallowed as a whole, and not to be chewed or crushed.

SCHEDULE H PRESCRIPTION DRUG- WARNING: To be sold by retail on the prescription of a Psychiatrist Only. 

STORAGE & DOSAGE:

Storage: Store at temperature not exceeding 30℃.
Store in cool, dry & dark place.
Protect from Light & moisture.

Dosage:  As directed by the Physician.

1. ➤ Introduction to Etizolam & Escitalopram Oxalate Tablets (0.5mg+10mg)

Etizolam & Escitalopram Oxalate Tablets (0.5mg+10mg) are a prescription-only combination medication that brings together two distinct pharmacological agents to create a powerful therapeutic synergy.

• Escitalopram Oxalate (10mg): A highly selective Serotonin Reuptake Inhibitor (SSRI), it works by increasing the levels of serotonin, a neurotransmitter in the brain that is crucial for maintaining mood balance. It is the cornerstone for the long-term management of Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD).

• Etizolam (0.5mg): A thienodiazepine derivative, it possesses potent anxiolytic, sedative, and muscle relaxant properties. It acts rapidly to alleviate acute symptoms of anxiety and panic, providing immediate relief while the escitalopram takes effect over several weeks.

This combination is strategically formulated to manage conditions where depression and anxiety co-exist. The Escitalopram provides the foundational, long-term antidepressant and anxiolytic effect, while the Etizolam offers immediate short-term relief from breakthrough anxiety and insomnia, facilitating better patient compliance during the initial phase of treatment.

Global Demand and Therapeutic Applications:
The international demand for this combination is significant and driven by several key factors:

• High Comorbidity Rates: The frequent co-occurrence of anxiety and depressive disorders necessitates combination therapies for effective management.

• Improved Treatment Outcomes: The synergistic effect can lead to faster symptom relief and improved long-term prognosis.

• Patient Compliance: By addressing both immediate and long-term symptoms, this combination can enhance patient adherence to the treatment regimen.

• Cost-Effective Care: As a generic combination product, it offers a more affordable option compared to sourcing and administering two separate medications, making it vital for public health systems.

This growing global demand underscores the need for a reliable and compliant Etizolam & Escitalopram Oxalate Tablets (0.5mg+10mg) Supplier capable of navigating the complex regulatory landscape associated with psychotropic substances.

2. ➤ A Buyer’s Guide: Essential Details for Importers & Distributors

Procuring a combination product that includes a controlled substance like Etizolam requires a manufacturer with robust regulatory expertise and operational integrity. Taj Pharma is structured to provide a seamless, transparent, and fully compliant sourcing experience.

➤ Regulatory Documentation and Compliance

We provide an exhaustive suite of documentation to facilitate smooth import processes, especially critical for medications containing psychotropic agents.

• Certificate of Pharmaceutical Product (COPP): Issued in line with WHO recommendations.

• WHO-GMP Certificate: Our facility is fully compliant with WHO Good Manufacturing Practices.

• Psychotropic Substance Licenses: We hold all necessary Indian regulatory licenses for the manufacture and export of Etizolam, as per the Narcotic Drugs and Psychotropic Substances (NDPS) Act.

• Certificate of Analysis (CoA): Batch-specific documentation confirming identity, potency, and purity of both active ingredients.

• CTD Dossier: A comprehensive Common Technical Document for regulatory submissions.

• Stability Studies Data: Full data supporting the product’s shelf life.

➤ Custom Packaging & Labeling

We offer tailored packaging solutions that respect the sensitive nature of the product and meet destination-country regulations.

• Blister Packing: Secure Alu-Alu blister packs to protect against moisture and tampering.

• Bottle Packing: HDPE bottles with child-resistant and tamper-evident closures.

• Regulatory Labeling: Compliance with destination country requirements for psychotropic drugs, including necessary symbols and warnings.

• Private Labeling: Full private labeling services available for distributors.

➤ Shelf-Life, Storage, and Dosage Form

• Dosage Form: Film-coated tablet for easy ingestion.

• Shelf-Life: 24 months from the date of manufacture.

• Storage Conditions: Store below 30°C in a dry place. Protect from light. Keep out of reach of children.

➤ Target Export Markets & Certifications

As a responsible Etizolam & Escitalopram Oxalate Tablets (0.5mg+10mg) exporter from India, we adhere to all international conventions and export primarily to countries where the product is approved for medical use. Our key markets include:

3. ➤ Why Taj Pharma is the Most Trusted Manufacturer & Exporter

Choosing Taj Pharma means partnering with an organization that places quality, compliance, and reliability at the forefront, especially for sensitive drug categories.

➤ State-of-the-Art Manufacturing & Uncompromising Quality

Our manufacturing plant in Vapi is equipped with dedicated production lines for psychotropic substances, featuring enhanced security and access controls. We employ advanced analytical techniques like HPLC for stringent in-process and finished product testing, ensuring each tablet delivers the precise 0.5mg+10mg dosage with impeccable purity and dissolution profiles.

➤ Affordable Pricing & Quality Assurance

We leverage our operational scale and vertical integration to offer Etizolam & Escitalopram Oxalate Tablets (0.5mg+10mg) at highly competitive prices without ever compromising on quality. This makes effective mental health treatment more accessible globally and provides our partners with significant market opportunities.

➤ Global Presence & Supply Chain Support

Our logistics team is highly experienced in handling the complex documentation and shipping requirements for controlled substances. We ensure secure and confidential shipping with full traceability, partnering with reliable freight forwarders to guarantee timely delivery.

4. ➤ Technical Product Specification Table

5. ➤ Call to Action: 

Sourcing a combination psychotropic medication requires a partner you can trust implicitly. Taj Pharma offers a partnership defined by ethical practices, regulatory mastery, and an unwavering commitment to quality.

Contact Taj Pharma today to discuss your requirements, request a quotation, or obtain sample and product literature. Let us be your reliable source for high-quality pharmaceutical combinations.

Contact Taj Pharma

Head Office:
Tel. No.: +91 – 22 – 2637 4592 / 2637 4593 (IST)
Fax: +91 – 22 – 2634 1274
Gen. Enquiry: +91 84484 44095

WhatsApp Support:
Mobile: +91 74 0000 9975 / +91 74 0000 9976

Email: info@tajpharma.com

6. ➤ Top 20 FAQs 

1. What is this combination tablet used for?
It is used for the treatment of conditions where depression and anxiety disorders co-exist, providing both immediate anxiolytic effects and long-term antidepressant action.

2. Who is the manufacturer?
Taj Pharma Ltd. is a leading Etizolam & Escitalopram Oxalate Tablets (0.5mg+10mg) Manufacturer in India.

3. Is this a controlled substance?
Yes, due to the presence of Etizolam, it is classified as a psychotropic substance and is subject to strict national and international regulations.

4. What are the serious side effects to watch for?
Serious side effects can include signs of serotonin syndrome (agitation, hallucinations, fever), severe dizziness, difficulty breathing, or signs of a severe skin reaction. Seek immediate medical attention if these occur.

5. Can this medicine be habit-forming?
Yes, the Etizolam component has the potential for dependence, especially with long-term use. It should be used exactly as prescribed by a doctor.

6. Do you provide the necessary export licenses for Etizolam?
Yes, we hold all valid Indian licenses for the manufacture and export of Etizolam-containing formulations and provide all required documentation for customs.

7. What is the MOQ?
We offer flexible MOQs. Please contact our sales team for specific details based on your region and requirements.

8. How is the product shipped?
We ship via secure and reliable logistics partners, with all necessary declarations for psychotropic substances as per international law.

9. What is the shelf life?
We provide a 24-month shelf life from the date of manufacture.

10. Can it be taken during pregnancy?
This combination is not recommended during pregnancy. A doctor must assess the risks and benefits before prescription.

11. How long does it take for Escitalopram to work?
The full antidepressant effect of Escitalopram may take 2-4 weeks to become apparent.

12. Do you offer a PCD Pharma Franchise for this product?
Yes, we offer franchise opportunities for qualified and licensed partners. Inquiries are invited.

13. What is your quality assurance process?
Our QA process includes rigorous raw material testing, in-process controls, and finished product testing against stringent pharmacopoeial standards.

14. Can you supply to our country?
We export to numerous countries where the product is approved. Contact us to confirm the status for your specific market.

15. What is the recommended dosage?
The dosage must be individualized by a physician. It is typically taken once daily.

16. Are there any food interactions?
It is generally advised to avoid alcohol. Grapefruit juice should be avoided as it may interact with Etizolam.

17. What should be done in case of a missed dose?
If it is close to the next dose, skip the missed dose. Do not double dose.

18. How should this medicine be discontinued?
This medication should not be stopped abruptly, especially Etizolam, due to the risk of withdrawal symptoms. A doctor will provide a tapering schedule.

19. Is driving safe while taking this medicine?
This medicine may cause drowsiness or dizziness. Patients should not drive or operate machinery until they know how it affects them.

20. How can I request a sample?
Samples are available for legally qualified and serious distributors. Please contact us with your business details.