Labetalol Tablets 100mg

Labetalol Tablets  100mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Labetalol Tablets USP 100mg
B) Labetalol Tablets USP 200mg
C) Labetalol Tablets USP 300mg
D) Labetalol Tablets USP 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Labetalol Tablets USP 100mg
Each film coated tablet contains:
Labetalol Hydrochloride USP………….100mg
Excipients…………………………………………q.s.
Colour: Lake of Erythrosine

B) Labetalol Tablets USP 200mg
Each film coated tablet contains:
Labetalol Hydrochloride USP…………..200mg
Excipients………………………………………..q.s.
Colour: Quinoline yellow WS

C) Labetalol Tablets USP 300mg
Each film coated tablet contains:
Labetalol Hydrochloride USP………….300mg
Excipients………………………………………..q.s.
Colour: Ferric oxide yellow

D) Labetalol Tablets USP 500mg
Each film coated tablet contains:
Labetalol Hydrochloride USP………….500mg
Excipients……………………………………….q.s.
Colour: Lake of indigo carmine

THERAPEUTIC INDICATIONS:

Labetalol is used with or without other medications to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.This medication is both an alpha blocker and beta blocker. It works by blocking the action of certain natural chemicals in your body such as epinephrine on the heart and blood vessels.

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 Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight container.
Dosage: As directed by the Physician

Attach dispensing label as per end country.

Introduction to Labetalol Tablets 100mg

Labetalol Tablets 100mg are a widely prescribed antihypertensive medication used globally for the treatment of hypertension, angina, and heart failure. Classified as an alpha and beta-blocker, Labetalol works by slowing down the heart rate and relaxing blood vessels, ultimately improving blood flow and reducing cardiovascular strain.

With cardiovascular ailments rising worldwide, the global demand for Labetalol Tablets 100mg has increased significantly across Asia, Africa, Latin America, CIS nations, and the Middle East. Importers, government procurement agencies, and distributors prefer reliable and WHO-GMP-compliant manufacturers — and this is where Taj Pharma stands out.

As a leading Labetalol Tablets 100mg Manufacturer in India, Taj Pharma ensures:

• High purity

• International-quality standards

• Affordable pricing

• Regulatory-ready documentation

Taj Pharma’s Labetalol Tablets 100mg have earned a reputation for consistency, stability, and export compatibility, making them the preferred choice for global pharmaceutical buyers.

Global Demand and Therapeutic Use

Labetalol is used worldwide due to its strong clinical efficacy in:

• Hypertension management

• Reducing heart-related chest pain (Angina)

• Heart failure treatment protocols

• Pregnancy-induced hypertension (PIH)

• Hypertensive emergencies

Its rapid onset, dual-action mechanism, and favorable safety profile make it indispensable in hospitals and outpatient treatment settings.

Common side effects include dizziness, fatigue, nausea, lightheadedness, and orthostatic hypotension—most of which subside as the body adjusts. Taj Pharma ensures clear dosage instructions and patient information leaflets with every export batch.

 The Most Trusted Labetalol Tablets 100mg Manufacturer in India

Taj Pharma Ltd., Vapi, Gujarat, is recognized as one of the top manufacturers, exporters, and suppliers of Labetalol Tablets 100mg in India. The company is backed by advanced WHO-GMP, ISO, and regulatory-compliant infrastructure, making it the preferred partner for global buyers.

Why Taj Pharma Leads the Market for Labetalol Tablets 100mg:

✔ 1. WHO-GMP & Internationally Certified Manufacturing

Taj Pharma’s production plants meet:

• WHO-GMP

• EU-GMP equivalent quality standards

• ISO 9001:2015

• PIC/S

• Schedule M compliance

Each batch undergoes rigorous quality testing, stability studies, and controlled environment packaging.

✔ 2. 100% Regulatory Documentation Support

Buyers receive complete and accurate documentation, including:

• COA (Certificate of Analysis)

• MSDS

• Batch Manufacturing Record

• FDA-approved DMF (where applicable)

• CTD/ACTD dossiers

• COPP

• Free Sale Certificate

• Stability data (Zone I–IV)

• GMP certificates

This makes Taj Pharma an ideal partner for:

• Tenders

• Institutional supply

• Registration in regulated/ semi-regulated countries

• Distributor onboarding

✔ 3. Customized Export Packaging

Taj Pharma offers tailor-made packaging solutions, including:

• Customer-branded designs

• Multilingual labeling

• Foil, blister, carton & bulk packs

• Anti-counterfeit markings

• Moisture-protection laminates

Shelf life: 36 months standard
Storage: Store below 25°C, protect from light

✔ 4. Advanced R&D and Quality Assurance

The QA and QC teams ensure:

• Uniformity of dose

• Dissolution & disintegration standards

• Impurity profile control

• API quality verification

• Microbial testing

Every batch is traceable, validated, and certified.

✔ 5. Competitive Pricing

Taj Pharma offers one of the best Labetalol Tablets 100mg prices in India, making it ideal for bulk buyers, PCD franchise partners, and export distributors.

✔ 6. Global Exporter to 20+ Countries

Taj Pharma exports to key markets, including:

India | Vietnam | UAE | Saudi Arabia | Kenya | Tanzania | Nigeria | Philippines | Cambodia | Ghana | Peru | Colombia | Uzbekistan | Kazakhstan | Sri Lanka | Myanmar | Yemen | Oman | South Africa | Chile

This strong export footprint positions Taj Pharma as a trusted global leader in Labetalol Tablets 100mg manufacturing.

PAN India Manufacturer & Supplier

Taj Pharma supplies across:

• Mumbai

• Delhi NCR

• Hyderabad

• Bengaluru

• Chennai

• Ahmedabad

• Pune

• Kolkata

Additionally:

• Labetalol Tablets 100mg Best Price in Mumbai Maharashtra

• Leading #1 Labetalol Tablets 100mg Manufacturer & Supplier in India

• Labetalol Tablets 100mg Manufacturer from Vapi, Gujarat

Technical Product Specification:  

PCD Pharma Franchise  

Taj Pharma offers exclusive PCD Pharma Franchise opportunities with:

• Monopoly rights

• Best pricing

• High promotional support

• Assured stock availability

Businesses across India choose Taj Pharma for long-term collaboration.

Top 20 FAQs  

1. What are Labetalol Tablets 100mg used for?

They treat hypertension, angina, heart failure, and certain hypertensive emergencies.

2. Who is the leading manufacturer of Labetalol Tablets 100mg in India?

Taj Pharma Ltd., Vapi, is the most trusted manufacturer and exporter.

3. Are export documents available?

Yes — COPP, CTD dossier, COA, FSC, GMP certificates, and more.

4. What certifications does Taj Pharma have?

WHO-GMP, ISO, PIC/S compliance, and international regulatory approvals.

5. What is the shelf life?

Standard 36 months.

6. Does Taj Pharma provide private labeling?

Yes — with customized brand, packaging, and market-specific artwork.

7. Is the product suitable for tender supply?

Absolutely. Complete regulatory support is provided.

8. What are common side effects?

Dizziness, fatigue, nausea, and lightheadedness.

9. Is this product safe in pregnancy?

Used in PIH—but only under medical supervision.

10. What is the packaging format?

Blister, strip, alu-alu, and bulk export packs.

11. Does Taj Pharma export globally?

Yes — to 20+ countries across Asia, Africa, LATAM, and CIS.

12. Minimum export order?

Flexible — depends on destination and form.

13. Are stability studies available?

Yes — as per ICH zones.

14. Is third-party manufacturing offered?

Yes — upon request.

15. Can distributors get monopoly rights?

Yes — under PCD franchise agreements.

16. Is the product affordable?

Taj Pharma offers highly competitive global pricing.

17. Do you provide samples?

Yes — for regulatory and quality evaluation.

18. Does Taj Pharma support registrations?

Yes — full documentation and regulatory assistance.

19. API source quality?

Sourced from certified and approved API suppliers.

20. Why choose Taj Pharma?

Quality, compliance, affordability, documentation, and global trust.

 Your Trusted Labetalol Tablets 100mg Export Partner

Taj Pharma stands as India’s No.1 Manufacturer, Supplier, and Exporter of Labetalol Tablets 100mg, backed by WHO-GMP infrastructure, global regulatory compliance, custom packaging, and robust supply chain capabilities. Whether you are an international importer, government procurement agency, distributor, or PCD franchise partner — Taj Pharma guarantees quality, reliability, and world-class service.