Gabapentin

Gabapentin is a widely prescribed anticonvulsant and neuropathic pain reliever, used for various neurological and chronic pain conditions. Initially developed as an adjunct therapy for epilepsy, it is now predominantly used in the management of postherpetic neuralgia, diabetic neuropathy, fibromyalgia, and restless leg syndrome (RLS).

At BluepillExpress, we specialize in the third-party manufacturing of Gabapentin in multiple strengths and dosage forms tailored to global therapeutic needs. As a WHO-GMP certified pharmaceutical manufacturer and global exporter, we offer scalable production, stringent quality controls, and comprehensive regulatory support. Our services enable pharmaceutical brands, hospitals, and government agencies to confidently launch Gabapentin products with consistent quality and proven therapeutic efficacy.

Product Overview

Product Name: Gabapentin
Therapeutic Class: Anticonvulsant / Neuropathic Pain Agent
Available Dosage Forms and Strengths:

• Capsules/Tablets:
  • Gabapentin 100 mg
  • Gabapentin 300 mg
  • Gabapentin 400 mg
  • Gabapentin 600 mg
  • Gabapentin 800 mg
• Oral Suspension: Gabapentin 250 mg/5 mL or as per client requirement (for pediatric or geriatric use)

Route of Administration: Oral
Packaging Options:

• Blister packs: Alu-Alu or PVC-Alu (10×10, 1×10, 3×10 formats)
• Bottles: HDPE or PET for tablets, suspension, or bulk packaging
• Carton with optional leaflet, customized per export requirement

Pharmacological Overview

Gabapentin is structurally related to the neurotransmitter GABA (gamma-aminobutyric acid), but it does not act directly on GABA receptors. Instead, it binds to the α2δ subunit of voltage-gated calcium channels in the central nervous system, reducing calcium influx and modulating neurotransmitter release.

This action leads to decreased neuronal excitability, making Gabapentin effective for both seizure control and neuropathic pain relief. Its multimodal application and relatively favorable side-effect profile make it an essential drug in modern medicine.

Mechanism of Action

Gabapentin binds with high affinity to the alpha-2-delta subunit of presynaptic voltage-gated calcium channels in the CNS. This binding reduces calcium entry, suppressing the release of excitatory neurotransmitters such as glutamate, substance P, and norepinephrine.

This mechanism contributes to Gabapentin’s anti-epileptic, analgesic, and anxiolytic effects, making it useful across various neurological and psychiatric conditions.

Indications

Gabapentin is approved and widely used for:

• Adjunctive treatment of partial seizures (with or without secondary generalization)
• Postherpetic neuralgia (PHN)
• Diabetic peripheral neuropathy
• Fibromyalgia
• Restless leg syndrome (RLS)
• Neuropathic pain associated with spinal cord injury
• Off-label uses include: anxiety disorders, migraine prophylaxis, menopausal hot flashes, and alcohol withdrawal symptoms

Pharmacokinetic Profile

• Absorption: Saturable, dose-dependent bioavailability (~60% at 900 mg/day)
• Onset of Action: Typically within 1–3 hours
• Half-life: 5–7 hours
• Metabolism: Not metabolized by the liver
• Excretion: Excreted unchanged via kidneys

Due to its renal excretion, dose adjustment is necessary in patients with renal impairment.

Why Choose BluepillExpress for Gabapentin Manufacturing?

1. WHO-GMP Certified Manufacturing Excellence

Our facilities adhere to WHO-GMP, ISO 9001:2015, and FSSAI standards. We maintain dedicated infrastructure for high-volume tablet and capsule manufacturing, supported by modern HVAC systems, cleanroom environments, and fully automated production lines.

All production is managed under strict SOPs, with real-time in-process controls and complete traceability.

2. Flexible Formulation Options

We offer tailored Gabapentin formulations for various market needs:

• Immediate-release tablets or capsules
• Sugar-free oral suspension (ideal for pediatric and geriatric patients)
• Co-blistered options with other pain management drugs
• Formulation variants such as non-GMO, vegetarian capsules, or gluten-free

Our R&D team is capable of formulating combination therapies or alternate dosage forms (e.g., chewable tablets or effervescent powders) on demand.

Comprehensive Quality Control

Every batch of Gabapentin manufactured by BluepillExpress undergoes rigorous testing in our in-house labs.

Quality assurance and control include:

• Assay and content uniformity (HPLC validated methods)
• Dissolution and disintegration tests
• Microbial limit testing
• Impurity profiling and residual solvent analysis
• Stability testing as per ICH guidelines
• Uniformity of weight, hardness, and friability (for tablets)
• Visual inspection for capsule integrity and color consistency

All QC data is recorded, reviewed, and released only upon QA approval.

Documentation and Regulatory Support

Our regulatory affairs division supports clients with full documentation for product registration in domestic and export markets.

Documentation includes:

• Certificate of Analysis (CoA)
• Certificate of Origin (CoO)
• GMP and ISO Certificates
• Batch Manufacturing Records (BMR)
• Product Specifications and Method of Analysis
• Stability data (accelerated and real-time)
• CTD or ACTD format dossiers (on request)
• Material Safety Data Sheets (MSDS)
• Free Sale Certificate (FSC)

We assist with product registration across Asia, Africa, Latin America, the CIS region, and the Middle East.

Packaging and Private Labeling

We offer complete packaging customization for global private-label requirements:

• Blister packs with foil printing and company branding
• Bottled suspensions with child-proof caps and dosing devices
• Printed leaflets in required languages
• Custom carton design with serialization and QR coding
• Eco-friendly, recyclable packaging options
• Compliant artwork for regulated markets (US, EU, Gulf, Africa)

Our packaging is tamper-evident, moisture-resistant, and compatible with varied climates.

Global Export and Distribution

BluepillExpress is a trusted supplier to over 35 countries and has extensive experience in:

• Government tenders and institutional supplies
• Public healthcare procurement (NGOs, Ministries of Health)
• Retail market distribution
• E-pharmacy and telemedicine supply chains
• Private-label export branding

We support global logistics through air and sea freight, ensuring cold chain or ambient conditions based on the product profile. We also provide third-party inspections (SGS, Intertek, Bureau Veritas) when required by clients.

Third-Party Manufacturing Process

Our seamless manufacturing process ensures quality, timeliness, and regulatory alignment:

1. Requirement Analysis
   • Product strength, dosage form, packaging, labeling, target market
2. Quotation and Agreement
   • Commercial terms, MOQ, lead times, documentation scope
3. Product Development (if required)
   • Trial batch creation, stability testing, regulatory review
4. Commercial Production and Quality Control
   • GMP-compliant manufacturing, real-time QA checks
5. Packaging and Labeling
   • Custom labeling and branding as per client request
6. Dispatch and Documentation
   • Shipping coordination and complete export paperwork

Standard delivery timeline: 30–40 working days (subject to batch size and customization).

Target Client Profiles

Our Gabapentin third-party manufacturing services are ideal for:

• Marketing companies with neurology and pain management portfolios
• Hospital procurement departments and chain pharmacies
• Government and NGO pharmaceutical supply projects
• International distributors and authorized importers
• Companies seeking private-label or branded generic collaborations

Gabapentin’s inclusion in many national formularies and essential medicine lists ensures consistent global demand.

Advantages of Partnering with BluepillExpress

• WHO-GMP compliant infrastructure for solid and liquid orals
• Robust regulatory support for multi-region product registrations
• End-to-end third-party/private label service
• High production capacity with guaranteed batch consistency
• Transparent pricing and contract structure
• Quick turnaround with adherence to quality timelines
• Experience in regulated, semi-regulated, and emerging markets

Conclusion

Gabapentin remains a high-value product in neurology and pain management due to its versatile therapeutic applications, reliable efficacy, and safety profile. As demand continues to grow across global markets, particularly for non-opioid pain alternatives and adjunct seizure therapies, Gabapentin is a strong addition to any pharmaceutical product portfolio.

At BluepillExpress, we combine scientific expertise, state-of-the-art facilities, and comprehensive client support to deliver world-class Gabapentin formulations. Our flexible manufacturing model and regulatory knowledge empower pharmaceutical companies to launch high-quality, market-ready products quickly and confidently.