GENERIC NAME OF THE MEDICINAL PRODUCT:
B. Bisoprolol Fumarate & Amlodipine Tablets (5mg+5mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film coated tablet contains:
Bisoprolol Fumarate IP……………...2.5mg
Amlodipine Besylate IP
Equivalent to Amlodipine…………..5mg
Excipients…………………………………...q.s
Colour: Erythrosine Lake & Indigo Carmine Lake
B) 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:
CAUTION & SCHEDULE:
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:
Store in cool, dry & dark place.
Protect from Light & moisture.
Dosage: As directed by the Physician.
Bisoprolol Fumarate & Amlodipine Tablets (2.5mg+5mg) Technical Specification:
| Product Name: | Bisoprolol Fumarate & Amlodipine Tablets |
| Brand Name: | Generic |
| Strength: | (2.5mg+5mg), (5mg+5mg) |
| Dosage Form: | Tablets (film coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10 strips of 10 Tablets Each |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Antihypertensive |
| Indication: | Bisoprolol/amlodipine combination therapy improves blood pressure control in patients with essential hypertension following monotherapy failure. |
| Storage: | Store at temperature not exceeding 30℃. Store in cool, dry & dark place. Protect from Light & moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Bisoprolol Fumarate & Amlodipine Tablets (2.5mg+5mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Bisoprolol Fumarate & Amlodipine Tablets (2.5MG+5MG)
Each film coated tablet contains:
Bisoprolol Fumarate IP………………2.5mg
Amlodipine Besylate IP
Equivalent to Amlodipine…………..5mg
Excipients……………………………………q.s
Colour: Erythrosine Lake & Indigo Carmine Lake
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 (2.5mg+5mg)
Bisoprolol Fumarate & Amlodipine Tablets (2.5mg+5mg) is a highly effective combination medication used in the management of high blood pressure (hypertension). It combines a beta-blocker (bisoprolol), which slows the heart rate and reduces cardiac workload, with a calcium channel blocker (amlodipine), which relaxes blood vessels and enhances blood flow. This synergistic formulation ensures better blood pressure control, minimizing the risk of cardiovascular events such as heart attacks and strokes.
Global demand for this medication is rising due to the increasing prevalence of hypertension and heart disease, making it a sought-after product for international distributors and pharmaceutical importers. Taj Pharma has emerged as a trusted Bisoprolol Fumarate & Amlodipine Tablets (2.5mg+5mg) manufacturer in India, catering to the growing global market.
In-Depth Details for Importers, Exporters, and Buyers
Regulatory Documentation Provided
Taj Pharma ensures full compliance with international standards, providing comprehensive regulatory documentation:
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Certificate of Analysis (COA) verifying purity, dosage strength, and safety
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Drug Master File (DMF) and CTD dossier for international submission
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WHO-GMP, EU-GMP, COPP certifications ensuring compliance for global markets
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Certificate of Pharmaceutical Product (CPP) for seamless regulatory approval
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Stability and safety reports confirming product reliability throughout its shelf life
Custom Packaging & Labeling
Taj Pharma supports customized packaging solutions to meet client needs:
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Primary packaging: blister packs, Alu-Alu strips, bottles
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Secondary packaging: branded cartons and boxes, client-specific designs
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Private labeling for PCD pharma franchisees and distributors
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Tamper-evident and child-resistant packaging for safe transport
Shelf-Life, Storage, and Dosage Form
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Shelf-life: 24–36 months
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Storage: Store in a cool, dry place (15–30°C), away from direct sunlight
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Dosage Form: Film-coated tablets (2.5mg bisoprolol + 5mg amlodipine)
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Usage Instructions: Take as prescribed; avoid sudden discontinuation to prevent rebound hypertension
Export Certifications & Quality Assurance
Taj Pharma follows strict quality control to meet international standards:
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WHO-GMP certified manufacturing units
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EU-GMP compliance for European markets
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CTD dossiers, COPP certificates, and DMF submission
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Rigorous in-process and batch testing for potency, uniformity, and microbial safety
Target Countries & Export Markets
Taj Pharma exports Bisoprolol Fumarate & Amlodipine Tablets (2.5mg+5mg) worldwide, including:
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Europe: Germany, UK, France, Italy, Spain
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Latin America: Brazil, Mexico, Argentina
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Middle East & North Africa: Saudi Arabia, UAE, Egypt
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Africa: Nigeria, Kenya, South Africa
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CIS & Southeast Asia: Russia, Singapore, Malaysia, Thailand, Philippines
Why Taj Pharma is the Most Trusted Manufacturer, Supplier, and Exporter
State-of-the-Art Manufacturing
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Modern GMP-compliant facilities in Vapi, Gujarat, India
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High-capacity production to fulfill domestic and international demand
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Advanced quality control measures ensuring batch-to-batch consistency
Affordable Pricing & Quality Assurance
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Competitive rates for bulk orders and PCD franchises
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High-quality testing including HPLC, dissolution, microbial limits, and heavy metals
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Assurance of safe, effective, and reliable antihypertensive therapy
Global Presence & Supply Chain Support
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Extensive international distribution network
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Assistance with product registration and regulatory submissions
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End-to-end supply chain management from manufacturing to delivery
Top 20 Countries Exporting
Taj Pharma exports Bisoprolol Fumarate & Amlodipine Tablets (2.5mg+5mg) to:
Nigeria | Kenya | Ghana | Tanzania | Uganda | Myanmar | Vietnam | Philippines | Yemen | Afghanistan | Iraq | Iran | Peru | Bolivia | Chile | Mexico | Dominican Republic | Nepal | Cambodia |Ethiopia
Technical Product Specification Table
| Specification | Details |
|---|---|
| Product Name | Bisoprolol Fumarate & Amlodipine Tablets (2.5mg+5mg) |
| API | Bisoprolol Fumarate + Amlodipine Besylate |
| Strength | 2.5mg + 5mg per tablet |
| Dosage Form | Film-coated tablets |
| Packaging Options | Blister packs, Alu-Alu packs, bottles |
| Storage Conditions | 15–30°C, dry, away from sunlight |
| Shelf-Life | 24–36 months |
| Regulatory Certifications | WHO-GMP, EU-GMP, CTD dossier, CPP, DMF |
| Documentation Provided | COA, DMF/CTD, Stability Reports, GMP Certificates |
| Export Markets | Europe, Latin America, MENA, CIS, Africa, Southeast Asia |
| Manufacturer Location | Vapi, Gujarat, India |
| Quality Assurance | HPLC, microbial, heavy metals, dissolution, batch traceability |
| Common Side Effects | Headache, edema, fatigue, dizziness |
| Safety Profile | Well-tolerated; consult physician if symptoms persist |
| Precautions | Avoid sudden discontinuation; inform doctor if pregnant or planning pregnancy |
Call to Action for Buyers & Distributors
Distributors, PCD pharma franchisees, and international buyers seeking a reliable Bisoprolol Fumarate & Amlodipine Tablets (2.5mg+5mg) supplier can contact Taj Pharma Ltd, Vapi, Gujarat. Key benefits include:
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WHO-GMP certified tablets
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Private-label and customized packaging
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Comprehensive regulatory support
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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
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What is Bisoprolol + Amlodipine 2.5mg+5mg used for?
Treats high blood pressure and reduces the risk of heart attack and stroke. -
How should it be taken?
As prescribed by your doctor, typically once daily. -
Can it be stopped suddenly?
No; abrupt discontinuation may raise blood pressure. -
Where is it manufactured?
Vapi, Gujarat, India by Taj Pharma Ltd. -
Is Taj Pharma WHO-GMP certified?
Yes; compliant with international quality standards. -
Which documents are provided for export?
COA, DMF/CTD, GMP certificates, CPP, and stability reports. -
What is the shelf-life?
24–36 months depending on storage conditions. -
Common side effects?
Headache, edema, fatigue, dizziness; usually mild and temporary. -
Can pregnant women take it?
Consult a doctor before use; inform your physician if planning pregnancy. -
Does it cause dizziness?
Yes, rise slowly from sitting or lying positions. -
Is it safe for elderly patients?
Dose adjustment may be required; consult your doctor. -
Can it be taken with alcohol?
Alcohol may enhance dizziness; avoid while taking this medication. -
How does it work?
Bisoprolol slows the heart rate; amlodipine relaxes blood vessels. -
Can it be used with other antihypertensives?
Yes, under physician supervision. -
Are private labeling options available?
Yes; fully customizable packaging for distributors. -
Export countries?
Europe, Latin America, MENA, CIS, Africa, Southeast Asia. -
Do you assist with regulatory registration?
Yes; full documentation and support provided. -
What quality tests are performed?
HPLC, microbial limits, dissolution, heavy metals, batch traceability. -
Can it be used for angina?
Yes, consult your physician for appropriate use. -
How to place an order?
Email info@tajpharma.com or visit Taj Pharma website.






