GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Nebivolol Tablets 2.5m
2. Nebivolol Tablets 5mg
3. Nebivolol Tablets 10mg
4. Nebivolol Tablets 20mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Nebivolol Tablets 2.5mg
Each uncoated tablet contains:
Nebivolol Hydrochloride
Equivalent to Nebivolol……….2.5mg
Excipients…………………………….q.s
Color: Sunset yellow FCF

2. Nebivolol Tablets 5mg
Each uncoated tablet contains:
Nebivolol Hydrochloride
Equivalent to Nebivolol……….5mg
Excipients…………………………….q.s
Color: Sunset yellow FCF


3. Nebivolol Tablets 10mg
Each uncoated tablet contains:
Nebivolol Hydrochloride
Equivalent to Nebivolol……….10mg
Excipients…………………………….q.s
Color: Caramel

4. Nebivolol Tablets USP 20mg
Each uncoated tablet contains:
Nebivolol Hydrochloride
Equivalent to Nebivolol……….20mg
Excipients…………………………….q.s
Color: Tartrazine yellow

THERAPEUTIC INDICATIONS:

Nebivolol is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Dispense in a tight, light-resistant container as defines in the USP using a child-resistant closure.
Keep container tightly closed.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end country.

Nebivolol Tablets 5mg Technical Specification:

Product Name: Nebivolol Tablets
Brand Name: Generic
Strength: (2.5mg), (5mg), (10mg), (20mg)
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: Antihypertensive
Indication: Nebivolol is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries.
Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Store in dry place protected from light and moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Nebivolol Tablets 2.5mg
2. Nebivolol Tablets 5mg

3. Nebivolol Tablets 10mg
4. Nebivolol Tablets 20mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Nebivolol Tablets 2.5mg
Each uncoated tablet contains:
Nebivolol Hydrochloride
Equivalent to Nebivolol……….2.5mg
Excipients…………………………….q.s
Color: Sunset yellow FCF

2.Nebivolol Tablets 5mg
Each uncoated tablet contains:

Nebivolol Hydrochloride
Equivalent to Nebivolol……….5mg
Excipients…………………………….q.s
Color: Sunset yellow FCF

3. Nebivolol Tablets 10mg
Each uncoated tablet contains:
Nebivolol Hydrochloride
Equivalent to Nebivolol……….10mg
Excipients…………………………….q.s
Color: Caramel

4. Nebivolol Tablets USP 20mg
Each uncoated tablet contains:
Nebivolol Hydrochloride
Equivalent to Nebivolol……….20mg
Excipients…………………………….q.s
Color: Tartrazine yellow

THERAPEUTIC INDICATIONS:

Nebivolol is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Dispense in a tight, light-resistant container as defines in the USP using a child-resistant closure.
Keep container tightly closed.

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).
Store in dry place protected from light and moisture.

Dosage: As directed by the Physician

Attach dispensing label as per end country.

Introduction to Nebivolol Tablets 5mg

Nebivolol Tablets 5mg is a prescription medication primarily used to manage high blood pressure (hypertension). It belongs to the beta-blocker class, which functions by relaxing blood vessels and slowing the heart rate. By improving blood flow and reducing blood pressure, Nebivolol helps prevent cardiovascular complications such as stroke, heart attack, and heart failure. It can be prescribed alone or in combination with other antihypertensive medications.

The global demand for Nebivolol Tablets 5mg has been steadily increasing due to the rising prevalence of hypertension worldwide. Healthcare providers are increasingly opting for beta-blockers like Nebivolol for their efficacy and minimal side effects. Taj Pharma, a trusted Nebivolol Tablets 5mg manufacturer in India, ensures high-quality, pure, and effective formulations for international markets.

In-Depth Details for Importers, Exporters, and Buyers

Regulatory Documentation Provided

Taj Pharma provides complete regulatory documentation for Nebivolol Tablets 5mg to facilitate international trade, including:

  • Certificate of Analysis (COA)
  • Drug Master File (DMF)
  • Certificate of Pharmaceutical Product (CPP)
  • CTD Dossier for regulatory submission
  • WHO-GMP and EU-GMP certifications

These documents ensure global compliance and instill confidence in international buyers regarding quality and safety.

Custom Packaging & Labeling

Taj Pharma offers tailored packaging and labeling solutions for international markets:

  • Multi-lingual labels as per country-specific regulations
  • Tamper-proof and child-resistant packaging
  • Customized branding options for distributors and PCD franchisees

Shelf-Life, Storage, Dosage Form

Nebivolol Tablets 5mg are manufactured in tablet form with a shelf-life of 24 months. Tablets should be stored in a cool, dry place, protected from direct sunlight to maintain potency and stability. This oral dosage form ensures easy administration and patient compliance.

Export Certifications

Taj Pharma is a leading Nebivolol Tablets 5mg exporter from India with globally recognized certifications:

  • WHO-GMP: Compliance with Good Manufacturing Practices
  • EU-GMP: Meeting European Union standards
  • COPP: Certificate of Pharmaceutical Product
  • CTD Dossier: Technical documentation for regulatory approvals

These certifications guarantee high-quality products for international distribution.

Target Countries & Export Markets

Taj Pharma exports Nebivolol Tablets 5mg to more than 20 countries, including the USA, UK, Germany, France, Australia, UAE, South Africa, Canada, Brazil, and several Southeast Asian countries, ensuring a strong global presence and reliable supply chain.

Why  is the Most Trusted Manufacturer, Supplier, and Exporter

State-of-the-Art Manufacturing

Taj Pharma’s manufacturing facility in Vapi, Gujarat, is equipped with advanced technology, automated production lines, and modern quality control labs. Every batch of Nebivolol Tablets 5mg undergoes stringent testing for purity, efficacy, and consistency.

Affordable Pricing & Quality Assurance

Taj Pharma offers competitive pricing without compromising on quality. Their rigorous quality control measures ensure uniformity and potency in every batch, making them a preferred choice for global buyers.

Global Presence & Supply Chain Support

With an extensive international network, Taj Pharma guarantees timely deliveries, customs support, and excellent customer service, establishing them as a leading Nebivolol Tablets 5mg supplier in India.

Top 20 Countries Exporting

  1. USA
  2. UK
  3. Germany
  4. France
  5. Australia
  6. Canada
  7. UAE
  8. South Africa
  9. Brazil
  10. Russia
  11. Saudi Arabia
  12. Singapore
  13. New Zealand
  14. Kenya
  15. Nigeria
  16. Italy
  17. Spain
  18. Malaysia
  19. Thailand
  20. Philippines

Technical Product Specification Table

Parameter Specification
Product Name Nebivolol Tablets 5mg
Dosage Form Tablet
Strength 5mg
Manufacturer Taj Pharma Ltd, Vapi, Gujarat, India
Storage Cool, dry place, away from sunlight
Shelf-Life 24 Months
Certifications WHO-GMP, EU-GMP, COPP, CTD Dossier
Therapeutic Use Hypertension and cardiovascular health
Side Effects Headache, fatigue, diarrhea, dizziness
Precautions May cause dizziness; rise slowly from sitting or lying position

Call to Action for Buyers and Distributors

Global buyers, distributors, and importers seeking a reliable Nebivolol Tablets 5mg manufacturer in India can contact Taj Pharma for competitive pricing, custom packaging, and export support.

Email: info@tajpharma.com
Phone: +91 74 0000 9976
Website: www.tajpharma.com

Top 20 FAQs

1. What is Nebivolol Tablets 5mg used for? It treats high blood pressure and supports heart health.

2. Who manufactures it in India? Taj Pharma Ltd, Vapi, Gujarat.

3. How should it be taken? As prescribed, usually once daily with or without food.

4. Common side effects? Headache, fatigue, diarrhea, dizziness.

5. Can it prevent heart attack and stroke? Yes, by lowering high blood pressure.

6. What certifications are provided? WHO-GMP, EU-GMP, COPP, CTD Dossier, DMF.

7. Is it exported globally? Yes, to over 20 countries.

8. Shelf-life? 24 months.

9. Is custom packaging available? Yes, including multilingual and tamper-proof packaging.

10. PCD franchise options available? Yes.

11. Dosage forms available? Tablet – 5mg.

12. Location of manufacturer? Vapi, Gujarat, India.

13. How does Nebivolol work? It relaxes blood vessels and slows heart rate, improving blood flow and reducing blood pressure.

14. Suitable for all age groups? Use under medical supervision.

15. Storage requirements? Cool, dry place away from sunlight.

16. Can it cause dizziness? Yes, rise slowly from sitting or lying positions.

17. Can it be used with other antihypertensives? Yes, under doctor guidance.

18. How to contact Taj Pharma? Email, phone, or website contact forms.

19. What export documents are provided? COA, CPP, DMF, CTD Dossier.

20. Why choose Taj Pharma? Advanced manufacturing, certified exports, competitive pricing, quality assurance, and global supply chain support.