Zolpidem Tartrate Prolonged-Release Tablets  12.5mg 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 12.5mg (ZOLPITAJ PR)

Zolpidem Tartrate Prolonged-Release Tablets 12.5mg (ZOLPITAJ PR) is a widely prescribed sedative-hypnotic medication used for the short-term treatment of insomnia, especially when patients experience difficulty with sleep onset or sleep maintenance. Classified under non-benzodiazepine hypnotics, it combines sedative, hypnotic, and anticonvulsant properties for improved sleep regulation.

Zolpidem works by binding to the GABA-A receptor complex, slowing down neural activity and promoting natural sleep onset. Because of its prolonged-release technology, ZOLPITAJ PR provides sustained therapeutic action throughout the night—helping users both fall asleep faster and stay asleep longer.

The global demand for Zolpidem Tartrate Prolonged-Release Tablets continues to rise across international markets due to increased insomnia prevalence, stress-induced sleep disorders, and the preference for safer non-benzodiazepine alternatives.

As a result, pharmaceutical companies, wholesalers, and government tenders worldwide actively seek reliable manufacturers in India who can supply consistent, high-quality, compliant pharmaceutical formulations.

This is exactly where Taj Pharma stands unmatched.

India’s Most Trusted Zolpidem Tartrate Prolonged-Release Tablets 12.5mg (ZOLPITAJ PR) Manufacturer

Taj Pharma, the renowned Zolpidem Tartrate Prolonged-Release Tablets 12.5mg (ZOLPITAJ PR) manufacturer in India, guarantees superior quality, purity, and therapeutic efficacy. Headquartered in Mumbai with world-class manufacturing units in Vapi, Gujarat, Taj Pharma is globally recognized for premium pharmaceutical formulations that comply with stringent international standards.

As a leading Export-Grade WHO-GMP, ISO, and EU-GMP compliant manufacturer, Taj Pharma supplies Zolpidem Tartrate Prolonged-Release Tablets 12.5mg to government agencies, hospitals, importers, and distributors worldwide.

Pharmacological Profile & Clinical Relevance

Zolpidem Tartrate belongs to the “Z-drugs” category, known for:

• Rapid hypnotic effects

• Lower risk of dependency compared to benzodiazepines

• Fewer residual hangover effects

• High patient compliance

Therapeutic Properties:

• Hypnotic

• Sedative

• Anticonvulsant

Common side effects include:

• Dizziness

• Drowsiness

• Diarrhea

• Sleepiness

Doctors commonly prescribe ZOLPITAJ PR for patients who need restful, uninterrupted sleep. It is recommended to be taken 30–45 minutes before bedtime and ideally without food to ensure optimal absorption.

Zolpidem Tartrate Prolonged-Release Tablets 12.5mg (ZOLPITAJ PR)

This section provides vital details required by international importers, distributors, and pharmaceutical procurement teams.

Regulatory Documentation Provided by Taj Pharma

Taj Pharma offers a complete set of regulatory documents necessary for global registrations:

• Certificate of Pharmaceutical Product (COPP)

• WHO-GMP certificate

• Certificate of Analysis (COA)

• FDA-compliant stability data

• CTD/ACTD dossier (modules 1–5)

• Free Sale Certificate

• Batch Manufacturing Records (BMR)

• Batch Packaging Records (BPR)

• MSDS and technical data sheets

• Export-ready labeling documents

• COA with every shipment

These documents ensure compliance with regulatory bodies across Asia, Africa, CIS, MENA, Latin America, and Europe.

Custom Packaging & Private Labeling Options

Taj Pharma offers export-customizable:

• Blister packs (Alu-Alu, PVC/PVDC)

• HDPE bottles / wide-mouth bottles

• Multi-language cartons

• Tamper-proof pharma packaging

• Custom branding for PCD/third-party clients

All packaging follows 21 CFR standards ensuring stability during transit.

Shelf-Life, Storage & Dosage Form

• Dosage form: Prolonged-release film-coated tablets

• Strength: 12.5mg

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

• Storage: Keep below 25°C, protected from light and moisture

• Shelf-life: 24–36 months (country-specific regulatory requirement)

Export Certifications from Taj Pharma

A globally recognized WHO-GMP manufacturer in India, Taj Pharma provides:

• WHO-GMP

• EU-GMP equivalent standards

• ISO 9001:2015 Quality Certification

• COPP for multiple countries

• cGMP compliance

• DMF/CTD dossiers

These certifications reinforce Taj Pharma’s credibility as an international pharmaceutical exporter.

Target Export Markets for ZOLPITAJ PR

Taj Pharma exports Zolpidem Tartrate PR Tablets across:

• South East Asia

• Latin America

• CIS nations

• Africa

• Middle East (GCC)

• Western Europe

• Caribbean Islands

Countries with the highest import volume include:

Nigeria, Kenya, Vietnam, Myanmar, Cambodia, Kazakhstan, Uzbekistan, Iraq, UAE, Saudi Arabia, Peru, Chile, Honduras, Ethiopia, Sri Lanka, Nepal, Afghanistan, Ghana, Colombia, and Yemen.

Why Taj Pharma is the No.1 Zolpidem Tartrate Prolonged-Release Tablets 12.5mg Manufacturer & Exporter in India

⭐ 1. State-of-the-Art WHO-GMP Manufacturing

Taj Pharma’s Vapi production facility is equipped with:

• Automated high-speed tableting machines

• International Standard Clean Rooms

• Inline quality monitoring systems

• Validated prolonged-release technology

• Stringent QA/QC processes

Their manufacturing complies with ICH, WHO, and PIC/S guidelines.

⭐ 2. Unmatched Quality Assurance

Each batch undergoes:

• Dissolution testing

• Uniformity of dosage units

• Impurity profiling

• Stability studies (real-time & accelerated)

• Microbiological assays

Taj Pharma guarantees 100% pure, safe, and stable formulations.

⭐ 3. Affordable Pricing for Global Buyers

India is the world’s largest producer of generics, and Taj Pharma is a pioneer in competitive export pricing for:

• Government tenders

• NGOs

• Wholesalers

• PCD franchises

• Hospitals

• Chain pharmacies

⭐ 4. Global Presence & Robust Supply Chain

Taj Pharma exports to over 40+ countries, offering:

• Fast dispatch

• Door-to-port shipping

• Multilingual documentation

• Reliable supply continuity

⭐ 5. Top 20 Countries 

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

Technical Product Specifications

Call to Action  

If you are an importer, distributor, government procurement agency, or PCD franchise, Taj Pharma is your most reliable partner for Zolpidem Tartrate Prolonged-Release Tablets 12.5mg (ZOLPITAJ PR).

✔ Premium quality
✔ Export-compliant packaging
✔ Affordable pricing
✔ Global supply capacity
✔ 100% regulatory documentation

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

Top 20 FAQs 

1. What is ZOLPITAJ PR?
A prolonged-release formulation of Zolpidem for insomnia management.

2. Who manufactures ZOLPITAJ PR in India?
Taj Pharma is the leading WHO-GMP-certified manufacturer.

3. What is the strength of the tablet?
12.5mg prolonged-release.

4. Is Zolpidem Tartrate safe for long-term use?
It is recommended for short-term use only unless medically advised.

5. Can Taj Pharma supply to government tenders?
Yes, Taj Pharma is an approved tender supplier.

6. What export documents are provided?
COPP, COA, CTD dossier, GMP certificate, FSC, and more.

7. What is the shelf-life?
24–36 months.

8. Do you offer custom packaging?
Yes, fully customizable export packaging.

9. Is WHO-GMP certification available?
Yes.

10. Do you export to Africa?
Yes, including Nigeria, Kenya, Ethiopia, Ghana.

11. Can buyers request private labeling?
Absolutely.

12. How long does dispatch take?
Typically 7–15 business days.

13. Do you provide free samples?
Samples are provided based on buyer credentials.

14. What clinical indications does Zolpidem treat?
Insomnia and sleep disturbances.

15. What are common side effects?
Dizziness, diarrhea, drowsiness.

16. Is the product registered globally?
Yes, in multiple countries.

17. Do you ship by air or sea?
Both.

18. Can small distributors order?
Yes, MOQs are flexible.

19. What standards does Taj Pharma follow?
WHO-GMP, ICH, EU regulations.

20. Why choose Taj Pharma?
Quality, affordability, regulatory compliance, and global trust.