Zolpidem Tartrate Prolonged-Release Tablets 6.25mg (ZOLPITAJ PR)

Zolpidem Tartrate Prolonged-Release Tablets 6.25mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Zolpidem Tartrate Prolonged-Release Tablets IP 6.25mg
2. Zolpidem Tartrate Prolonged-Release Tablets IP 12.5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Zolpidem Tartrate Prolonged-Release Tablets IP 6.25mg
Each Film-coated Prolonged-Release tablet contains:
Zolpidem Tartrate IP……….……6.25mg
Excipients……………………………..q.s
Colour: Sunset yellow FCF

2. Zolpidem Tartrate Prolonged-Release Tablets IP 12.5mg
Each Film-coated Prolonged-Release tablet contains:
Zolpidem Tartrate IP……….……12.5mg
Excipients……………………………..q.s
Colour: Sunset yellow

THERAPEUTIC INDICATIONS:

Zolpidem is indicated for the short-term treatment of insomnia in adults in situations where the insomnia is debilitating or is causing severe distress for the patient.

CAUTION & SCHEDULE:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.

SCHEDULE: SCHEDULE H1 CAUTION: IT IS DANGEROUS TO TAKE THIS PREPARATION EXCEPT IN ACCORDANCE WITH MEDICAL ADVICE.

TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Store below 30°C.

Protect from Light and moisture.

Dosage: As directed by the Physician.

Introduction: Understanding Zolpidem Tartrate Prolonged-Release Tablets 6.25mg (ZOLPITAJ PR)

Zolpidem Tartrate Prolonged-Release Tablets 6.25mg (ZOLPITAJ PR) is a widely prescribed sedative-hypnotic medication used for the short-term treatment of insomnia. Patients with difficulty falling asleep or maintaining sleep often benefit greatly from this prolonged-release formulation, which provides smoother and sustained therapeutic action throughout the night.

Belonging to the pharmacological class of non-benzodiazepine hypnotics, Zolpidem Tartrate offers hypnotic, sedative, and anticonvulsant effects. It acts by binding to the GABA-A receptor complex, reducing neuronal excitability and promoting natural sleep onset. The 6.25mg prolonged-release strength is commonly prescribed for elderly patients, those requiring mild therapeutic dosing, or individuals sensitive to higher strengths.

The demand for Zolpidem Tartrate Prolonged-Release Tablets 6.25mg has grown tremendously in global markets due to rising insomnia prevalence and increased preference for safer non-benzodiazepine alternatives.

This increased demand has positioned India—and specifically Taj Pharma—as a preferred global supplier due to its unmatched quality, compliance, and export readiness.

  India’s Leading Manufacturer of Zolpidem Tartrate PR 6.25mg Tablets

Taj Pharma, the well-known Zolpidem Tartrate Prolonged-Release Tablets 6.25mg (ZOLPITAJ PR) manufacturer in India, guarantees exceptional quality, purity, and regulatory compliance. With manufacturing facilities located in Vapi, Gujarat, Taj Pharma adheres to stringent WHO-GMP, ISO, and cGMP pharmaceutical manufacturing standards.

Backed by years of expertise, Taj Pharma supplies ZOLPITAJ PR to:

• Government procurement agencies

• International hospitals

• Pharmaceutical distributors

• Global wholesalers

• PCD Pharma franchise networks

Their Zolpidem formulations are widely recognized for stability, efficacy, and global compliance.

Pharmacology & Clinical Relevance of ZOLPITAJ PR 6.25mg

Zolpidem is classified under “Z-drugs,” known for:

• Rapid sleep induction

• Lower dependency risk than benzodiazepines

• Minimal next-day sedation

• Excellent tolerability

Patients prescribed the 6.25mg prolonged-release variant benefit from:

• Faster sleep initiation

• Improved sleep quality

• Reduced nighttime awakenings

Common side effects:
Dizziness, drowsiness, diarrhea, sleepiness—typically mild and transient.

Doctors recommend taking the tablet 30 to 45 minutes before bedtime, preferably on an empty stomach, as high-fat meals can delay absorption.

Users must ensure they have at least 7 hours of sleep time available before taking the medication.

Comprehensive Buyer & Importer Guide

This section details what global buyers, importers, tender authorities, and distributors should know before sourcing Zolpidem Tartrate Prolonged-Release Tablets 6.25mg (ZOLPITAJ PR) from India.

1. Regulatory Documentation Provided by Taj Pharma

Taj Pharma supplies complete regulatory and technical documentation required for registration across international markets:

• WHO-GMP Certificate

• Certificate of Pharmaceutical Product (COPP)

• Free Sale Certificate (FSC)

• COA for every batch

• CTD/ACTD dossiers (Modules 1–5)

• Stability studies (real-time & accelerated)

• Manufacturing License

• MSDS

• GMP-compliant batch production records (BMR/BPR)

• Analytical method validation (AMV)

• Packaging inserts in multilingual formats

This makes Taj Pharma a preferred partner for international pharmaceutical registrations.

2. Custom Packaging & Export Labeling Options

Global buyers can opt for:

• ALU-ALU Blister Packs

• PVC/PVDC Blisters

• HDPE Bottles

• Private-label or custom branding

• Export-grade cartons with country-specific artwork

• Multilingual labeling for MENA, ASEAN, LATAM, and CIS

Packaging adheres to 21 CFR-compliant standards ensuring product stability across global supply chains.

3. Shelf-Life, Storage, and Dosage Form

• Dosage Form: Prolonged-release film-coated tablet

• Strength: 6.25mg

• Packaging: 10×10 / 3×10 blister or bottle packs

• Shelf-life: 24–36 months

• Storage: Below 25°C; protect from moisture and sunlight

All batches go through accelerated and real-time stability testing under ICH guidelines.

4. Export Certifications from Taj Pharma

Taj Pharma is globally known for its certification standards, making it a top exporter of Zolpidem Tartrate Prolonged-Release Tablets 6.25mg:

• WHO-GMP

• ISO 9001:2015

• cGMP-compliant facility

• COPP for product registration

• CTD dossiers for regulatory submissions

• Third-party lab validation reports

These certifications enhance market acceptability and ensure global trust.

5. Target Export Markets for ZOLPITAJ PR 6.25mg

Taj Pharma exports this product to:

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

• Asia: Vietnam, Myanmar, Cambodia, Sri Lanka

• CIS: Kazakhstan, Uzbekistan, Kyrgyzstan

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

• Latin America: Peru, Chile, Honduras, Colombia

• Europe & Caribbean: select regulated and semi-regulated markets

Taj Pharma’s export reach spans 40+ nations, with growing demand annually.

Why Taj Pharma is the Most Trusted Manufacturer and Exporter

⭐ 1. State-of-the-Art Manufacturing Facilities

The Vapi facility is equipped with:

• High-speed tablet compression machines

• Advanced fluid bed processing systems

• Automatic blister packing lines

• Controlled environment production zones

• Fully automated quality assurance labs

Their quality systems meet global standards including ICH Q7, Q8, Q9, and Q10.

⭐ 2. Strict Quality Control & High Purity Assurance

Every batch undergoes rigorous testing:

• Assay & impurity profiling

• Microbiological evaluations

• Dissolution testing

• Uniformity & hardness tests

• Stability evaluations

Taj Pharma ensures 100% compliance, purity, and therapeutic accuracy.

⭐ 3. Competitive Pricing for Global Buyers

Taj Pharma is known for delivering:

• WHO-GMP quality

• International standards

• Competitive pricing

• Excellent supply consistency

This makes them a preferred supplier for:

• Government tenders

• NGOs

• Hospitals

• Large distributors

• PCD pharma networks

⭐ 4. Global Supply Chain & Export Reliability

Buyers choose Taj Pharma for:

• On-time delivery

• Seamless logistics support

• Global distribution expertise

• Documentation support

• Flexible MOQs (minimum order quantities)

This ensures smooth import operations for customers worldwide.

⭐ Top 20 Countries  

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 Table

Call to Action  

If you are looking for a trusted, WHO-GMP-certified Zolpidem Tartrate Prolonged-Release Tablets 6.25mg (ZOLPITAJ PR) Manufacturer and Supplier in India, Taj Pharma is your best partner.

They provide:

✔ High-quality export-grade products
✔ Affordable global pricing
✔ Comprehensive regulatory support
✔ Fast delivery to 40+ countries
✔ Custom packaging & private branding

Contact Taj Pharma Today:
📧 info@tajpharma.com
🌐 www.tajpharma.com
📍 Mumbai & Vapi, Gujarat, India

Top 20 FAQs  

1. What is ZOLPITAJ PR 6.25mg used for?
   Short-term treatment of insomnia.

2. Who is the best manufacturer in India?
   Taj Pharma.

3. Is it safe for elderly patients?
   Yes, 6.25mg is commonly prescribed for elderly individuals.

4. What is its pharmacological class?
   Non-benzodiazepine hypnotics (“Z-drugs”).

5. Does Taj Pharma export globally?
   Yes, to 40+ countries.

6. What certifications are available?
   WHO-GMP, COPP, CTD dossiers, ISO.

7. Can buyers request private labeling?
   Yes, fully customizable.

8. Does it require a prescription?
   Yes, it is a prescription medication.

9. What side effects may occur?
   Dizziness, diarrhea, drowsiness.

10. How should it be taken?
    30–45 minutes before bedtime, on an empty stomach.

11. Does Taj Pharma support regulatory submissions?
    Yes, with full CTD dossiers.

12. Is the product stable during shipping?
    Yes, with export-grade packaging.

13. What is the MOQ?
    Flexible based on buyer needs.

14. Is technical documentation provided?
    Yes, including COA, stability, and CTD.

15. Is it suitable for PCD Pharma franchise?
    Yes.

16. How long does shipping take?
    Typically 7–15 days depending on destination.

17. Is the product affordable?
    Yes, highly cost-effective.

18. Does Taj Pharma provide samples?
    Available on request.

19. Can it be registered in foreign markets?
    Yes, with Taj Pharma’s regulatory files.

20. Why choose Taj Pharma?
    Quality, compliance, trust, and export reliability.