GENERIC NAME OF THE MEDICINAL PRODUCT:
Pramipexole Dihydrochloride Tablets USP 0.75mg
Pramipexole Dihydrochloride Tablets USP 1.5mg
Pramipexole Dihydrochloride Tablets USP2.25mg
Pramipexole Dihydrochloride Tablets USP 3mg
Pramipexole Dihydrochloride Tablets USP 3.75mg
Pramipexole Dihydrochloride Tablets USP 4mg
Pramipexole Dihydrochloride Tablets USP 4.5mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film-coated tablet contains:
Pramipexole Dihydrochloride USP…………………….0.375mg
Excipients……………………………q.s.
Colours: Ferric Oxide (Red) USP-NF, Ferric Oxide (Yellow) USP-NF
Pramipexole Dihydrochloride Tablets USP 0.75mg
Each film-coated tablet contains:
Pramipexole Dihydrochloride USP…………………….0.75mg
Excipients……………………………q.s.
Colours: Ferric Oxide (Red) USP-NF, Ferric Oxide (Yellow) USP-NF
Pramipexole Dihydrochloride Tablets USP 1.5mg
Each film-coated tablet contains:
Pramipexole Dihydrochloride USP…………………….1.5mg
Excipients……………………………q.s.
Colours: Ferric Oxide (Red) USP-NF, Ferric Oxide (Yellow) USP-NF
Pramipexole Dihydrochloride Tablets USP 2.25mg
Each film-coated tablet contains:
Pramipexole Dihydrochloride USP…………………….2.25mg
Excipients……………………………q.s.
Colours: Ferric Oxide (Red) USP-NF, Ferric Oxide (Yellow) USP-NF
Pramipexole Dihydrochloride Tablets USP 3mg
Each film-coated tablet contains:
Pramipexole Dihydrochloride USP…………………….3mg
Excipients……………………………q.s.
Colours: Ferric Oxide (Red) USP-NF, Ferric Oxide (Yellow) USP-NF
Pramipexole Dihydrochloride Tablets USP 3.75mg
Each film-coated tablet contains:
Pramipexole Dihydrochloride USP…………………….3.75mg
Excipients……………………………q.s.
Colours: Ferric Oxide (Red) USP-NF, Ferric Oxide (Yellow) USP-NF
Pramipexole Dihydrochloride Tablets USP 4mg
Each film-coated tablet contains:
Pramipexole Dihydrochloride USP…………………….4mg
Excipients……………………………q.s.
Colours: Ferric Oxide (Red) USP-NF, Ferric Oxide (Yellow) USP-NF
Pramipexole Dihydrochloride Tablets USP 4.5mg
Each film-coated tablet contains:
Pramipexole Dihydrochloride USP…………………….4.5mg
Excipients……………………………q.s.
Colours: Ferric Oxide (Red) USP-NF, Ferric Oxide (Yellow) USP-NF
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Warning:
To be sold by retail on the prescription of a neurologist only.
STORAGE & DOSAGE:
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in a tight container.
Dosage:
As directed by the Neurologist.
Pramipexole Dihydrochloride Tablets USP 4.5mg Technical Specification:
| Product Name: | Pramipexole Dihydrochloride Tablets USP |
| Brand Name: | Generic |
| Strength: | 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3mg, 3.75mg, 4mg, 4.5mg |
| Dosage Form: | Tablets (Uncoated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Anti-Parkinson, Central Nervous System |
| Indication: | Pramipexole is used to treat Parkinson disease. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Pramipexole Dihydrochloride Tablets USP 0.375mg
- Pramipexole Dihydrochloride Tablets USP 0.75mg
- Pramipexole Dihydrochloride Tablets USP 1.5mg
- Pramipexole Dihydrochloride Tablets USP2.25mg
- Pramipexole Dihydrochloride Tablets USP 3mg
- Pramipexole Dihydrochloride Tablets USP 3.75mg
- Pramipexole Dihydrochloride Tablets USP 4mg
- Pramipexole Dihydrochloride Tablets USP 4.5mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Pramipexole Dihydrochloride Tablets USP 0.375mg
Each film-coated tablet contains:
Pramipexole Dihydrochloride USP…………………….0.375mg
Excipients……………………………q.s.
Colours: Ferric Oxide (Red) USP-NF, Ferric Oxide (Yellow) USP-NF - Pramipexole Dihydrochloride Tablets USP 0.75mg
Each film-coated tablet contains:
Pramipexole Dihydrochloride USP…………………….0.75mg
Excipients……………………………q.s.
Colours: Ferric Oxide (Red) USP-NF, Ferric Oxide (Yellow) USP-NF - Pramipexole Dihydrochloride Tablets USP 1.5mg
Each film-coated tablet contains:
Pramipexole Dihydrochloride USP…………………….1.5mg
Excipients……………………………q.s.
Colours: Ferric Oxide (Red) USP-NF, Ferric Oxide (Yellow) USP-NF - Pramipexole Dihydrochloride Tablets USP 2.25mg
Each film-coated tablet contains:
Pramipexole Dihydrochloride USP…………………….2.25mg
Excipients……………………………q.s.
Colours: Ferric Oxide (Red) USP-NF, Ferric Oxide (Yellow) USP-NF - Pramipexole Dihydrochloride Tablets USP 3mg
Each film-coated tablet contains:
Pramipexole Dihydrochloride USP…………………….3mg
Excipients……………………………q.s.
Colours: Ferric Oxide (Red) USP-NF, Ferric Oxide (Yellow) USP-NF - Pramipexole Dihydrochloride Tablets USP 3.75mg
Each film-coated tablet contains:
Pramipexole Dihydrochloride USP…………………….3.75mg
Excipients……………………………q.s.
Colours: Ferric Oxide (Red) USP-NF, Ferric Oxide (Yellow) USP-NF - Pramipexole Dihydrochloride Tablets USP 4mg
Each film-coated tablet contains:
Pramipexole Dihydrochloride USP…………………….4mg
Excipients……………………………q.s.
Colours: Ferric Oxide (Red) USP-NF, Ferric Oxide (Yellow) USP-NF - Pramipexole Dihydrochloride Tablets USP 4.5mg
Each film-coated tablet contains:
Pramipexole Dihydrochloride USP…………………….4.5mg
Excipients……………………………q.s.
Colours: Ferric Oxide (Red) USP-NF, Ferric Oxide (Yellow) USP-NF
THERAPEUTIC INDICATIONS:
Pramipexole has some of the same effects as a chemical called dopamine, which occurs naturally in your body. Low levels of dopamine in the brain are associated with Parkinson’s disease.
CAUTION & WARNING:
CAUTION:Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Warning:To be sold by retail on the prescription of a neurologist only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in a tight container.
Dosage:As directed by the Neurologist.
1. Introduction to Pramipexole Dihydrochloride Tablets USP 4.5mg
Pramipexole Dihydrochloride Tablets USP 4.5mg is a high-strength dopamine agonist used in the management of Parkinson’s disease and Restless Legs Syndrome (RLS). It acts on dopamine receptors in the brain, helping restore motor function, reduce tremors, and improve coordination.
This high-dose formulation is typically prescribed for advanced-stage neurological conditions where lower doses are insufficient. With the rising global burden of Parkinson’s disease, demand for Pramipexole 4.5mg is growing rapidly across developed and developing markets.
Taj Pharma the well-knownPramipexole Dihydrochloride Tablets USP 4.5mgmanufacturer in India gives the assurance of high-quality and purity. Topiramate Capsules USP 15 mg are an FDA-approved, AB-rated generic medication. Functioning as an anticonvulsant and nerve stabilizer, they are primarily used to treat seizures and prevent migraine headaches.
2. Therapeutic Uses and Global Demand
Pramipexole Dihydrochloride Tablets USP 4.5mg is widely used for:
- Parkinson’s disease management
- Restless Legs Syndrome (RLS)
- Dopamine deficiency disorders
- Motor impairment conditions
- Neurological rehabilitation therapy
Taj Pharma is well established Manufacturer, Exporter and Supplier ofPramipexole Dihydrochloride Tablets USP 4.5mgfrom Vapi, Gujarat India. is used for epilepsy/seizures, epilepsy, Prevention of migraine, mania, Lennox–Gastaut syndrome, migraine, trigeminal neuralgia and seizures.
Global Growth Factors:
- Increasing aging population worldwide
- Rising neurological disease prevalence
- Improved diagnosis and treatment access
- Expanding pharmaceutical exports from India
- Demand for cost-effective therapies
3. Mechanism of Action
Taj Pharma Ltd India is well recognized Manufacturer, Exporter and Supplier ofPramipexole Dihydrochloride Tablets USP 4.5mgfrom Vapi, is an antiepileptic medication. It controls seizures or fits by decreasing the abnormal and excessive activity of the nerve cells in the brain.
Pramipexole acts by stimulating dopamine receptors (D2 and D3), leading to:
- Improved motor control
- Reduced muscle stiffness
- Decreased tremors
- Better movement coordination
- Enhanced neurological stability
4. Safety Profile and Side Effects
Taj Pharma is well known Manufacturer, Exporter and Supplier ofPramipexole Dihydrochloride Tablets USP 4.5mgfrom Vapi, Gujarat India. Dizziness, Fatigue, Fever, Paresthesia (tingling or pricking sensation), Psychomotor impairment, Sleepiness, Speech disorder, Weight loss, Decreased appetite, Joint pain, Abnormal vision
Common Side Effects:
- Drowsiness
- Nausea
- Fatigue
- Dizziness
- Sleep disturbance
Important Usage Guidance:
Taj Pharma Ltd is Top known Manufacturer, Exporter and Supplier ofPramipexole Dihydrochloride Tablets USP 4.5mgfrom Vapi, Gujarat India. Take your medication regularly as directed by your doctor as missing doses can trigger seizures. Do not change the brand of your medicine and make sure that you have sufficient amount of medicine present with you.
5. Patient Care Instructions
Taj Pharma is Best Known Manufacturer, Exporter and SupplierPramipexole Dihydrochloride Tablets USP 4.5mgfrom Vapi, Gujarat India. Keep yourself hydrated by drinking plenty of fluids throughout the day while taking Topiramate. This can reduce the risk of kidney stones.
Key Instructions:
- Take at the same time daily
- Avoid alcohol consumption
- Do not discontinue abruptly
- Follow neurologist’s prescription
- Regular monitoring recommended
6. Regulatory Documentation & Compliance
Taj Pharma ensures full global compliance for export markets.
Documents Provided:
- WHO-GMP certification
- EU-GMP compliance
- COPP certificate
- CTD dossier
- Stability studies
- Batch manufacturing records
- Quality assurance certificates
7. Packaging, Storage & Shelf Life
Packaging Options:
- Blister packs
- HDPE bottles
- Export cartons
- OEM/private labeling
Shelf Life:
- 24–36 months
Storage Conditions:
- Store below 25°C
- Protect from moisture and light
Dosage Form:
- Tablets USP 4.5mg
8. Global Export Markets
Pramipexole Dihydrochloride Tablets USP 4.5mg is widely exported due to rising neurological healthcare needs.
Top Import Countries:
- USA
- UK
- Germany
- France
- Italy
- Spain
- Canada
- Brazil
- Mexico
- UAE
- Saudi Arabia
- South Africa
- Nigeria
- Kenya
- Egypt
- Vietnam
- Thailand
- Indonesia
- Philippines
- Sri Lanka
9. Why Taj Pharma is the Most Trusted Manufacturer & Exporter
Taj Pharma is a globally trusted name in pharmaceutical manufacturing, known for excellence in neurology drug production.
Key Strengths:
1. Advanced Manufacturing Facilities
WHO-GMP compliant production units ensure consistent quality.
2. Affordable Global Pricing
Cost-effective manufacturing makes treatment accessible worldwide.
3. Strong Export Network
Efficient logistics ensure timely international delivery.
4. Trusted Global Partner
Reliable supplier for hospitals, distributors, and healthcare systems.
10. Top 20 Export Countries
- USA
- UK
- Germany
- France
- Italy
- Spain
- Canada
- Brazil
- Mexico
- UAE
- Saudi Arabia
- South Africa
- Nigeria
- Kenya
- Egypt
- Vietnam
- Thailand
- Indonesia
- Philippines
- Sri Lanka
11. Technical Specification Table
| Parameter | Details |
|---|---|
| Product Name | Pramipexole Dihydrochloride Tablets USP 4.5mg |
| Active Ingredient | Pramipexole Dihydrochloride |
| Strength | 4.5mg |
| Dosage Form | Tablets |
| Class | Dopamine Agonist |
| Indications | Parkinson’s disease, RLS |
| Packaging | Blister / Bottle |
| Shelf Life | 24–36 months |
| Storage | Below 25°C |
| Manufacturer | Taj Pharma |
| Origin | India |
12. Call to Action
For bulk supply, export partnership, or pharmaceutical distribution of Pramipexole Dihydrochloride Tablets USP 4.5mg, Taj Pharma is your trusted global manufacturing partner.
Services include:
- Bulk export supply
- OEM/private labeling
- PCD pharma franchise
- International distribution contracts
- Regulatory documentation support
13. Top 20 FAQs
1. What is Pramipexole 4.5mg used for?
Parkinson’s disease and RLS.
2. Is it a dopamine agonist?
Yes.
3. Does it cure Parkinson’s?
No.
4. Is it prescription-based?
Yes.
5. Does it cause drowsiness?
Yes.
6. Can it be exported?
Yes.
7. Shelf life?
24–36 months.
8. Is it taken daily?
Yes.
9. Manufacturer in India?
Taj Pharma.
10. Is alcohol allowed?
No.
11. Does it improve movement?
Yes.
12. Is dose adjustable?
Only doctor decides.
13. Is it addictive?
No.
14. Refrigeration needed?
No.
15. Long-term use safe?
Yes under supervision.
16. OEM available?
Yes.
17. Bulk export possible?
Yes.
18. Does it treat epilepsy?
No.
19. How to order?
Contact export team.
20. Global availability?
Yes.


















