Bisoprolol Fumarate & Amlodipine Tablets (5mg+5mg)

Bisoprolol Fumarate & Amlodipine Tablets (5mg+5mg) Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Bisoprolol Fumarate & Amlodipine Tablets (5mg+5mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Bisoprolol Fumarate & Amlodipine Tablets (5MG+5MG)
  Each film coated tablet contains:
  Bisoprolol Fumarate IP………………5mg
  Amlodipine Besylate IP
  Equivalent to Amlodipine…………..5mg
  Excipients……………………………………q.s
  Colour: Ferric oxide Yellow USP-NF, Brilliant
  Blue Lake & Ferric Oxide black USP-NF

THERAPEUTIC INDICATIONS:

 Bisoprolol/amlodipine combination therapy improves blood pressure control in patients with essential hypertension following monotherapy failure.

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: SCHEDULE H PRESCRIPTION DRUG CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

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.

Introduction to Bisoprolol Fumarate & Amlodipine Tablets (5mg+5mg)

Bisoprolol Fumarate & Amlodipine Tablets (5mg+5mg) is a combination medication widely prescribed to manage high blood pressure (hypertension). It merges a beta-blocker (bisoprolol), which slows the heart rate, with a calcium channel blocker (amlodipine), which relaxes blood vessels, resulting in improved blood flow and reduced cardiovascular risk.

This dual-action formulation is increasingly in demand globally due to rising hypertension prevalence, providing doctors and patients a convenient, effective, and well-tolerated option for controlling blood pressure. With growing international markets, Bisoprolol Fumarate & Amlodipine Tablets (5mg+5mg) manufacturer in India has become a key player for importers and distributors worldwide.

In-Depth Details for Importers, Exporters, and Buyers

Regulatory Documentation Provided

Taj Pharma ensures international buyers receive complete regulatory documentation to simplify import and distribution:

• Certificate of Analysis (COA) confirming purity, dosage accuracy, and safety

• Drug Master File (DMF) and CTD dossier detailing formulation, stability, and production

• WHO-GMP, EU-GMP, and COPP certifications for global compliance

• Certificate of Pharmaceutical Product (CPP) to facilitate regulatory approvals

• Stability and safety reports ensuring consistent quality throughout shelf-life

Custom Packaging & Labeling

Taj Pharma provides customized packaging and labeling for PCD pharma franchisees and distributors:

• Primary packaging: blister packs, Alu-Alu packs, bottles

• Secondary packaging: branded cartons tailored to client specifications

• Private labeling available for international markets

• Tamper-evident and child-resistant options for secure transport

Shelf-Life, Storage, and Dosage Form

• Shelf-life: 24–36 months

• Storage: Store at 15–30°C, away from direct sunlight and moisture

• Dosage Form: Film-coated tablets (5mg bisoprolol + 5mg amlodipine)

• Usage Guidance: Take as prescribed; avoid abrupt discontinuation to prevent rebound hypertension

Export Certifications & Quality Assurance

Taj Pharma ensures global quality compliance with:

• WHO-GMP certified production units

• EU-GMP compliance for European markets

• CTD dossiers, COPP certificates, and DMF submission

• In-process and batch testing for potency, uniformity, and safety

Target Countries & Export Markets

Taj Pharma exports Bisoprolol Fumarate & Amlodipine Tablets (5mg+5mg) to a wide array of countries:

• Europe: Germany, UK, France, Italy, Spain

• Latin America: Brazil, Mexico, Argentina

• Middle East & North Africa: Saudi Arabia, UAE, Egypt

• Africa: Nigeria, Kenya, South Africa

• CIS & Southeast Asia: Russia, Singapore, Malaysia, Thailand, Philippines

This ensures seamless supply to healthcare providers and distributors worldwide.

Why Taj Pharma is the Most Trusted Manufacturer, Supplier, and Exporter

State-of-the-Art Manufacturing

• Advanced GMP-compliant production facilities in Vapi, Gujarat, India

• Scalable capacity to meet domestic and global demand

• Robust quality control protocols ensuring batch-to-batch consistency

Affordable Pricing & Quality Assurance

• Competitive pricing for bulk orders and PCD franchisees

• High-quality testing including HPLC, dissolution, microbial limits, and heavy metals

• Assurance of safe, effective, and reliable antihypertensive therapy

Global Presence & Supply Chain Support

• Extensive international distribution network

• Assistance with product registration and regulatory submissions

• End-to-end supply chain management from manufacturing to delivery

Top 20 Countries Exporting

Taj Pharma exports Bisoprolol Fumarate & Amlodipine Tablets (5mg+5mg) to:

USA, UK, South Africa, Kenya, Nigeria, Ghana, Vietnam, Myanmar, Philippines, Bangladesh, Sri Lanka, Iraq, Yemen, Uzbekistan, Kazakhstan, Georgia, Peru, Bolivia, Ukraine, Cambodia

Technical Product Specification Table

Call to Action for Buyers & Distributors

Distributors, PCD pharma franchisees, and international buyers seeking a reliable Bisoprolol Fumarate & Amlodipine Tablets (5mg+5mg) supplier can contact Taj Pharma Ltd, Vapi, Gujarat. Key benefits include:

• WHO-GMP certified tablets

• Private-label and customized packaging

• Comprehensive regulatory support

• End-to-end supply chain management

Contact Taj Pharma Ltd today at  info@tajpharma.com or visit www.tajpharma.com to secure high-quality antihypertensive tablets for global distribution.

Top 20 FAQs

1. What is Bisoprolol + Amlodipine 5mg+5mg used for?
   Treats high blood pressure and reduces risk of heart attack and stroke.

2. How should it be taken?
   As prescribed by your doctor, typically once daily.

3. Can it be stopped suddenly?
   No; abrupt discontinuation may raise blood pressure.

4. Where is it manufactured?
   Vapi, Gujarat, India by Taj Pharma Ltd.

5. Is Taj Pharma WHO-GMP certified?
   Yes; compliant with international quality standards.

6. Which documents are provided for export?
   COA, DMF/CTD, GMP certificates, CPP, and stability reports.

7. What is the shelf-life?
   24–36 months depending on storage conditions.

8. Common side effects?
   Headache, edema, fatigue, dizziness; usually mild and temporary.

9. Can pregnant women take it?
   Consult a doctor before use; inform your physician if planning pregnancy.

10. Does it cause dizziness?
    Yes, rise slowly from sitting or lying positions.

11. Is it safe for elderly patients?
    Dose adjustment may be required; consult your doctor.

12. Can it be taken with alcohol?
    Alcohol may enhance dizziness; avoid while taking this medication.

13. How does it work?
    Bisoprolol slows the heart rate; amlodipine relaxes blood vessels.

14. Can it be used with other antihypertensives?
    Yes, under physician supervision.

15. Are private labeling options available?
    Yes; fully customizable packaging for distributors.

16. Export countries?
    Europe, Latin America, MENA, CIS, Africa, Southeast Asia.

17. Do you assist with regulatory registration?
    Yes; full documentation and support provided.

18. What quality tests are performed?
    HPLC, microbial limits, dissolution, heavy metals, batch traceability.

19. Can it be used for angina?
    Yes, consult your physician for appropriate use.

20. How to place an order?
    Email  info@tajpharma.com or visit the Taj Pharma website