Pregabalin

The global prevalence of neuropathic pain, generalized anxiety disorder, and fibromyalgia continues to rise, driving demand for effective, well-tolerated treatments. Pregabalin, a structural analog of gamma-aminobutyric acid (GABA), has gained recognition as a first-line therapy for neuropathic pain and adjunctive therapy in seizures. Its rapid onset, high oral bioavailability, and multi-indication effectiveness make it a cornerstone of neurological and psychiatric treatment worldwide.

At BluepillExpress, we offer third-party manufacturing solutions for Pregabalin in various dosage strengths and formulations. With WHO-GMP and ISO-certified facilities, international regulatory expertise, and flexible production capabilities, we empower pharmaceutical brands, distributors, and healthcare providers across the globe to deliver quality, reliable, and affordable Pregabalin products.

About BluepillExpress

BluepillExpress is a global pharmaceutical manufacturer and exporter providing full-spectrum third-party manufacturing services. With a presence in over 30 countries spanning Asia, Africa, Latin America, the Middle East, and CIS regions, we support pharmaceutical companies, hospitals, government tenders, and private brands in bringing compliant, effective, and competitively priced medicines to market.

Key competencies include:

• WHO-GMP and ISO 9001:2015 certified production units
• CTD/ACTD dossier preparation and regulatory support
• Custom packaging, private label branding, and artwork development
• Logistics and export services with country-specific documentation
• Flexible MOQs for startups and established pharmaceutical companies

Our Pregabalin formulations are manufactured with strict adherence to global quality standards and designed to address a range of neurological and psychiatric disorders.

Product Overview: Pregabalin

Pregabalin is an antiepileptic and analgesic agent that binds to the alpha2-delta subunit of voltage-gated calcium channels in the central nervous system. It modulates neurotransmitter release and is highly effective in reducing neuropathic pain, managing partial-onset seizures, and alleviating anxiety disorders.

Pharmacological Class: Anticonvulsant / Neuropathic Pain Agent
Mechanism of Action: Binds to alpha2-delta subunit of calcium channels, reducing excitatory neurotransmitter release

Formulations Offered by BluepillExpress:

• Pregabalin 25 mg Capsules
• Pregabalin 50 mg Capsules
• Pregabalin 75 mg Capsules
• Pregabalin 100 mg Capsules
• Pregabalin 150 mg Capsules
• Pregabalin 300 mg Capsules

We also offer Pregabalin combinations (e.g., Pregabalin + Methylcobalamin) upon request.

Therapeutic Indications

Pregabalin is prescribed for a variety of conditions, including:

• Neuropathic pain associated with diabetic peripheral neuropathy or spinal cord injury
• Postherpetic neuralgia
• Fibromyalgia
• Adjunctive therapy for partial-onset seizures in adults
• Generalized Anxiety Disorder (GAD)
• Restless Leg Syndrome (off-label in some regions)

Due to its rapid efficacy and good safety profile, Pregabalin is often used when first-line therapies fail or are contraindicated.

Clinical Benefits of Pregabalin

• High oral bioavailability (~90%)
• Rapid onset of action—symptomatic relief often within days
• Effective for both central and peripheral neuropathic pain
• Reduces anxiety symptoms without sedative dependence
• Minimal hepatic metabolism—suitable for hepatic-impaired patients
• Favorable side effect profile and low abuse potential (compared to benzodiazepines)

Manufacturing Capabilities at BluepillExpress

Our advanced infrastructure ensures the safe, efficient, and quality-assured production of Pregabalin in multiple strengths and formats.

Key Features:

• Dedicated Beta-Lactam-Free Manufacturing Zones
• Granulation, Encapsulation, and Blistering Lines for high-volume batch processing
• Cleanroom Facilities meeting cGMP and environmental control standards
• In-process Monitoring Systems to ensure dosage accuracy and capsule uniformity
• In-house QC and Microbiology Labs with HPLC, dissolution, and assay testing capabilities

Our facilities are equipped to handle both small-scale pilot batches and bulk commercial quantities.

Packaging & Presentation

We offer customized packaging solutions for both prescription and over-the-counter Pregabalin products:

Capsule Packaging:

• Alu-Alu blister packs (10×10, 10×15)
• Alu-PVC blister strips
• HDPE bottles with desiccant (for bulk supply or hospital use)

Branding Support:

• Private labeling with client’s brand and logo
• Custom inserts in regional languages
• QR-coded labels for authentication and serialization
• Regulatory-compliant carton and label design for different export markets

All packaging is subjected to stability testing and complies with international track & trace mandates.

Quality Control and Assurance

At BluepillExpress, quality is our foundation. Every Pregabalin product undergoes multi-stage quality validation, including:

• Raw Material Testing: Identity, assay, microbial count, and heavy metal detection
• In-process Controls (IPQC): Capsule weight, fill uniformity, disintegration
• Finished Product Testing: Content uniformity, dissolution, microbial limits
• Packaging and Label Inspection: Batch number, expiry, label integrity
• Stability Studies: Conducted under ICH-recommended conditions (Zone II & IVa/b)

All batches are accompanied by:

• Certificate of Analysis (CoA)
• Batch Manufacturing Record (BMR)
• Material Safety Data Sheet (MSDS)
• Shelf-life and storage data

Shelf Life and Storage Conditions

• Typical Shelf Life: 24 to 36 months (depending on packaging format and formulation)
• Recommended Storage: Store in a dry place below 30°C, away from direct sunlight and moisture
• Packaging Enhancements: Moisture-resistant Alu-Alu blisters for tropical climates

Regulatory & Export Documentation

To support seamless product registration and importation, BluepillExpress provides:

• Certificate of Pharmaceutical Product (COPP)
• Free Sale Certificate
• WHO-GMP and ISO Certifications
• CTD/ACTD-compliant Dossiers
• Stability data, method validation, and process validation
• Product Artwork Templates
• CoA and MSDS for each shipment

We assist in registration for Ministries of Health (MOH) in countries across Africa, Asia, the Middle East, and Latin America.

Private Label and Custom Manufacturing Services

BluepillExpress enables clients to build their own branded line of Pregabalin products with:

• Custom dosage forms and strengths
• Brand-specific packaging and logo printing
• Marketing support materials (inserts, product brochures)
• Regulatory exclusivity agreements
• Low MOQs for market testing or small launches
• Confidentiality agreements and brand IP protection

Logistics & Global Export Support

Our global logistics team ensures fast, compliant, and secure delivery of Pregabalin consignments:

• Support for air, sea, and multimodal shipments
• Cold chain or climate-controlled logistics (if required)
• Export-ready packaging for multiple destination zones
• Real-time tracking and delivery confirmation
• Customs clearance documentation and destination labeling support

We serve government tenders, hospital supply chains, pharmacy networks, and institutional buyers.

Target Clients and Partners

Our Pregabalin third-party manufacturing solutions are ideal for:

• Generic pharmaceutical companies expanding CNS portfolios
• Hospital procurement agencies and group purchasing organizations
• Private label OTC brands
• Government tenders and NGO health programs
• Distributors of neurological and psychiatric drugs
• Online pharmacy platforms looking to expand chronic care lines

Why Choose BluepillExpress for Pregabalin Manufacturing?

• WHO-GMP and ISO 9001:2015 certified facilities
• Decade-long experience in manufacturing neuropathic and psychiatric formulations
• Global dossier-ready Pregabalin with CTD/ACTD formats
• Custom formulation and branding flexibility
• Competitive pricing and scalable production
• Reliable lead times and export fulfillment support
• Regulatory registration and artwork design services
• Long-term partnerships with global pharmaceutical distributors

Conclusion

Pregabalin continues to be a key therapeutic agent in the treatment of neuropathic pain, epilepsy, and anxiety disorders. At BluepillExpress, we are committed to delivering high-quality Pregabalin formulations through world-class third-party manufacturing services. From formulation to packaging and regulatory compliance, we support our clients every step of the way to bring this critical medicine to patients across global markets.

Whether you’re launching a new brand, expanding your therapeutic portfolio, or supplying to government tenders, BluepillExpress ensures excellence in every capsule.