Gabapentin Tablets USP 100mg: Unveiling Quality and Standards in Pharmaceutical Manufacturing

Table of Contents

  1. Introduction
  2. Gabapentin Tablets USP 100mg at Taj Pharma
    1. Quality Assurance and Standards
    2. Manufacturing Process
  3. Technical Specifications
    1. Product Information
    2. Dosage Forms and Strengths
    3. Therapeutic Use and Indications
  4. Composition Details
    1. Qualitative and Quantitative Composition
    2. Therapeutic Indications
  5. Caution and Warning
    1. Leaflet Instructions
    2. Storage and Dosage Guidelines
  6. Taj Pharma: A Trusted Pharmaceutical Manufacturer
    1. Company Overview
    2. Commitment to Innovation and Growth
  7. Contact Information
    1. Direct Line and Toll-Free Numbers
    2. Manufacturing Plant Details
  8. Conclusion
  9. FAQs

Introduction

In the realm of pharmaceuticals, the significance of quality and standards cannot be overstated. This article delves into the realm of Gabapentin Tablets USP 100mg, particularly focusing on the manufacturing prowess of Taj Pharma in India.

Gabapentin Tablets USP 100mg at Taj Pharma

Quality Assurance and Standards

At Taj Pharma, the commitment to high standards is unwavering. Strict quality control measures are in place to ensure that each batch of Gabapentin Tablets meets harmonious standards. The adherence to ISH (International Standards for Harmonization) positions Taj Pharma as a leading player in the global pharmaceutical market.

Manufacturing Process

The manufacturing process at Taj Pharma involves the utilization of Gabapentin Tablets grade best active ingredients. This ensures compliance with transnational norms, especially those set by European regulatory bodies. The emphasis on quality begins with the selection of raw materials and extends throughout the production process.

Technical Specifications

Product Information

  • Product Name: Gabapentin Tablets USP
  • Brand Name: Generic
  • Strength: 100mg, 300mg, 600mg, 800mg
  • Dosage Form: Tablets (Film-coated)
  • 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: Anticonvulsant, Central Nervous System
  • Indication: Gabapentin is an anticonvulsant medication primarily used to treat partial seizures and neuropathic pain.

Composition Details

  • Generic Name of the Medicinal Product: Gabapentin Tablets USP
  • Qualitative and Quantitative Composition:
    • Gabapentin Tablets USP 100mg: Each film-coated tablet contains Gabapentin USP 100mg, Excipients q.s., Colour: Titanium Dioxide
    • Gabapentin Tablets USP 300mg: Each film-coated tablet contains Gabapentin USP 300mg, Excipients q.s., Colour: Quinoline yellow WS
    • Gabapentin Tablets USP 600mg: Each film-coated tablet contains Gabapentin USP 600mg, Excipients q.s., Colour: Ponceau 4 R
    • Gabapentin Tablets USP 800mg: Each film-coated tablet contains Gabapentin USP 800mg, Excipients q.s., Colour: Ferric Oxide Red

Therapeutic Indications

Gabapentin is a first-line medication for the treatment of neuropathic pain caused by diabetic neuropathy, postherpetic neuralgia, and central pain.

Caution and Warning

Leaflet Instructions

  • Caution: Read the enclosed leaflet before use.
  • Keep Out of Reach: Keep medicine out of reach of children.
  • Administration: Swallow whole, do not chew or crush.
  • Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

Storage and Dosage Guidelines

  • Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
  • Protection: Protect from light and moisture.
  • Dosage: As directed by the Physician.
  • Dispensing Label: Attach dispensing label as per end country.

Taj Pharma: A Trusted Pharmaceutical Manufacturer

Company Overview

Taj Pharma India Limited stands as a reputable pharmaceutical player with 12 years of visionary leadership. The company’s commitment to innovation and growth is evident in its top-quality healthcare products.

Commitment to Innovation and Growth

Committed to transparency and customer-centricity, Taj Pharma emerges as a trusted partner for superior pharmaceutical solutions. The company’s adherence to WHO-cGMP, GMP, GLP-approved standards, and various international certifications reflects its commitment to excellence.

Contact Information

For inquiries about the company, healthcare business, or medicines, contact Taj Pharma India through:

  • Direct Line: +9184484 44095 / +91 74 0000 9975 / 76
  • Toll-Free: 1800 222 434 / 825

Manufacturing Plant:

Taj Pharma India Ltd. Plot No.1019, Sarigam G.I.D.C., Road No. 10, Dist. – Valsad, Gujarat 396142, India WHO-cGMP, GMP, GLP Approved, EU-GMP, PICs, PPB Kenya, Ivory Coast GMP, INVIMA, Anvisa etc. ISO 9001 2018, SGS

Conclusion

In the realm of pharmaceuticals, Taj Pharma sets the bar high for quality and standards. The Gabapentin Tablets USP 100mg exemplify the company’s commitment to providing effective and reliable healthcare solutions.

FAQs

  1. Are Gabapentin Tablets USP 100mg suitable for all age groups?
    • These tablets are generally prescribed for specific conditions. Consult a healthcare professional for personalized advice.
  2. What sets Taj Pharma apart from other pharmaceutical manufacturers?
    • Taj Pharma stands out due to its unwavering commitment to quality, innovation, and customer-centricity.
  3. Can Gabapentin Tablets USP 100mg be taken without a prescription?
    • No, these tablets should only be taken as per the prescription of a Registered Medical Practitioner.
  4. How should Gabapentin Tablets USP 100mg be stored?
    • Store them at 20° to 25°C (68° to 77°F), protected from light and moisture.
  5. Is Taj Pharma open to collaborations or partnerships?
    • For inquiries regarding collaborations, please contact the provided phone numbers.