Description

Bisoprolol Tablets (2.5mg / 5mg / 10mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)

Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Bisoprolol Fumarate Tablets in India. Bisoprolol is a highly Cardioselective Beta-1 Adrenergic Blocker. Unlike older beta-blockers, it specifically targets the heart muscle with minimal effect on the lungs, making it the preferred choice for patients with Chronic Heart Failure, Hypertension, and Stable Angina Pectoris, especially those with co-existing respiratory issues.

We offer Contract Manufacturing (Third Party) services for this critical cardiovascular drug. Bisoprolol is prescribed in very precise, low doses (starting at 1.25mg for heart failure). Our WHO-GMP certified facility in Mumbai utilizes advanced Automated Weight Control and high-precision blending technology to ensure exceptional Content Uniformity—guaranteeing that every fraction of the tablet delivers the exact life-saving dose. Healthy Inc manages the export logistics, supplying cardiology centers and pharmacy chains across Europe, the CIS region, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Precision dosage for the failing heart.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Cardioselectivity Preservation: We use high-purity Bisoprolol Fumarate to ensure the highest ratio of Beta-1 selectivity. This minimizes side effects like bronchoconstriction (wheezing) common with non-selective blockers.

  • Titration-Friendly Design: Heart failure treatment requires “Starting Low and Going Slow.” Our tablets are engineered with deep Score Lines (break lines) to allow patients to easily split a 5mg tablet into 2.5mg, facilitating the strict titration schedule required by cardiologists.

  • Moisture Protection: Bisoprolol is sensitive to moisture. We use Alu-Alu (Cold Form) packaging to provide a hermetic seal, ensuring stability in humid climates.

• The Exporter: Healthy Inc

  • Compliance Packs: We can design “Calendar Blister Packs” (marked Mon-Sun) to help elderly patients track their daily medication adherence.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Content Uniformity: We perform rigorous statistical testing (AV value) to ensure strict dose consistency, critical for the 2.5mg strength.

• Dissolution: We test release profiles to ensure >80% of the drug releases within 30 minutes.

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

5. Why Use Bisoprolol?

The heart’s “brake pedal.”

• Mechanism: Bisoprolol blocks Beta-1 Receptors on the heart muscle cells. This prevents adrenaline (epinephrine) from stimulating the heart.

  • Result: It slows down the heart rate and reduces the force of contraction. This lowers blood pressure and, crucially, reduces the heart’s demand for oxygen, preventing angina pain and allowing a failing heart to pump more efficiently over time.

• Key Indications:

  • Chronic Heart Failure (CHF): Increases survival and reduces hospitalization in stable heart failure patients.

  • Hypertension: Lowers blood pressure to prevent stroke and kidney damage.

  • Angina Pectoris: Prevents chest pain by reducing cardiac workload.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Bisoprolol Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Is it Concor?

  A: Concor is the brand name (Merck). We manufacture the Generic Equivalent (Bisoprolol Fumarate), which is bioequivalent.

• Q: Is it safe for Asthmatics?

  A: Generally Yes. Because it is “Cardioselective,” it is much safer for lungs than drugs like Propranolol. However, caution is still advised; strictly follow your doctor’s guidance.

• Q: Can I stop taking it suddenly?

  A: ABSOLUTELY NOT. Stopping a beta-blocker suddenly can cause “Rebound Hypertension” or even a heart attack. You must wean off it slowly under medical supervision.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Hypertension / Angina: 5mg once daily. May increase to 10mg or 20mg max.

• Heart Failure: Strict Titration. Start 1.25mg daily for 1 week. Increase slowly over weeks (2.5mg -> 3.75mg -> 5mg -> etc.) to target maintenance of 10mg daily.

• Administration: Take once daily in the morning, with or without food. Swallow whole.

9. Side Effects and Precautions

• Cardiovascular: Bradycardia (too slow heart rate), Hypotension, Cold extremities (fingers/toes).

• General: Fatigue, dizziness (usually improves after 2 weeks).

• Respiratory: Dyspnea (shortness of breath) in sensitive patients.

• Metabolic: May mask symptoms of Hypoglycemia (low sugar) in diabetics (specifically the palpitations).

• Contraindications: Acute Heart Failure (decompensated), Bradycardia (<60 bpm), AV block.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from moisture.