Celecoxib

Celecoxib is a selective cyclooxygenase-2 (COX-2) inhibitor, classified under nonsteroidal anti-inflammatory drugs (NSAIDs). It is widely prescribed for the treatment of pain, inflammation, and joint disorders, particularly in osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and dysmenorrhea. Due to its selective mechanism of action, Celecoxib offers powerful anti-inflammatory and analgesic effects while minimizing gastrointestinal side effects often associated with non-selective NSAIDs.

BluepillExpress, a WHO-GMP certified pharmaceutical contract manufacturer, offers end-to-end third-party manufacturing services for Celecoxib tablets and capsules. We provide high-quality formulations for both prescription and over-the-counter (OTC) segments, complete with regulatory compliance, customizable packaging, and export documentation to cater to local and international pharmaceutical brands.

Product Overview

Generic Name: Celecoxib
Pharmacological Class: Selective COX-2 Inhibitor (NSAID)
Therapeutic Use: Anti-inflammatory, analgesic, antipyretic
Mechanism of Action: Inhibits prostaglandin synthesis via selective COX-2 inhibition

Available Dosage Forms and Strengths

Capsules:

• Celecoxib 100 mg
• Celecoxib 200 mg
• Celecoxib 400 mg (on request or in special indications)

Formulations are available in solid gelatin capsules and vegetarian capsules upon request. We also accommodate modified release systems for extended therapeutic coverage or reduced dosing frequency.

Packaging Options

• Alu-Alu blister packs (10×10 or 10×15 formats)
• PVC/Alu blister packs (cost-effective option)
• HDPE or PET bottles (30s, 60s, 100s)
• Multilingual cartons and inserts for export
• Private label and institutional branding supported

All packaging is designed with tamper-evident features and adheres to international stability and safety standards.

Therapeutic Indications

Celecoxib is indicated for the relief and management of:

• Osteoarthritis
• Rheumatoid arthritis
• Ankylosing spondylitis
• Acute pain and musculoskeletal injury
• Primary dysmenorrhea (menstrual cramps)
• Post-operative pain
• Juvenile rheumatoid arthritis (selected markets and formulations)

Due to its COX-2 selectivity, Celecoxib may be considered safer for patients at risk of gastric ulcers or bleeding, compared to traditional NSAIDs.

Mechanism of Action

Celecoxib functions by selectively inhibiting the COX-2 enzyme, which is involved in the synthesis of prostaglandins that mediate pain, inflammation, and fever. Unlike non-selective NSAIDs (e.g., ibuprofen or diclofenac), Celecoxib does not significantly inhibit COX-1, an enzyme involved in gastrointestinal protection.

Benefits of COX-2 Selectivity:

• Reduced risk of gastric irritation, ulceration, and bleeding
• Effective pain relief and anti-inflammatory action
• Suitable for long-term management of chronic arthritis

Pharmacokinetics

• Bioavailability: Approximately 40%
• Time to Peak Concentration: 2–4 hours after oral administration
• Protein Binding: >97%
• Metabolism: Extensively metabolized in the liver via CYP2C9
• Half-life: ~11 hours
• Excretion: Mainly via feces and urine as metabolites

The pharmacokinetic profile allows twice-daily dosing, supporting improved patient compliance for chronic pain conditions.

Why Choose BluepillExpress for Celecoxib Manufacturing?

1. WHO-GMP and ISO-Certified Facilities

At BluepillExpress, our manufacturing plants operate with:

• Dedicated lines for NSAID production
• High-speed encapsulation machines for precise dosage filling
• Air-locked cleanroom environments for sterile and contamination-free production
• Batch homogenizers and mixers for uniform blend and content
• Blister packing and bottling lines with in-line vision inspection

Every production process adheres to cGMP standards, ISO 9001:2015, and Schedule M guidelines, ensuring consistency, safety, and compliance.

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2. Customized Formulation Capabilities

We support:

• Immediate release capsules
• Modified release formulations (on request)
• Capsule shell customization (color, branding, vegetarian shells)
• Combination formulations (Celecoxib with paracetamol or other analgesics)
• Special formulations for regulated markets (e.g., sugar-free, gluten-free)

Our formulation scientists also assist with bioequivalence strategies, stability studies, and scale-up development for specialized markets.

Quality Assurance and Quality Control

BluepillExpress maintains a robust QA/QC system that ensures regulatory-compliant, pharmacopeia-grade product manufacturing.

Quality Tests Include:

• Assay and dissolution testing (per USP/Ph. Eur. standards)
• Content uniformity and weight variation
• Disintegration and friability
• Microbial limit and endotoxin testing
• Stability testing under ICH conditions (Zone II & Zone IV)
• Impurity profiling and residual solvent analysis

All testing is supported by validated SOPs and analytical instruments, ensuring repeatable and reliable quality metrics.

Regulatory Documentation Support

We offer complete regulatory and export documentation to facilitate product registration across various global markets.

Documents Provided:

• Certificate of Analysis (CoA)
• Batch Manufacturing Record (BMR)
• Free Sale Certificate (FSC)
• Certificate of Origin (CoO)
• Material Safety Data Sheet (MSDS)
• Method of Analysis (MoA)
• Stability Data (Real-time and Accelerated)
• CTD/ACTD-format dossiers
• Bioequivalence (on request for regulated markets)
• WHO-GMP Certificate

We have a dedicated team to assist with regulatory filing and technical correspondence with authorities and distributors.

Private Label and Brand Customization Services

BluepillExpress supports third-party and private-label partnerships, including:

• Branded packaging with client’s name, logo, and design
• Multilingual labeling and inserts (French, Spanish, Arabic, etc.)
• Customization for different therapeutic segments (orthopedic, gynecology, general medicine)
• Blister card designs suitable for OTC display
• Hospital supply branding for public health institutions

We enable both small-batch branding for startups and bulk production for established marketing companies.

Export Capabilities

We are a trusted export manufacturer of NSAIDs and pain relief medications, with shipments reaching:

• Africa – Nigeria, Kenya, Ghana, Ethiopia
• Latin America – Bolivia, Peru, Honduras
• Middle East – Iraq, Yemen, UAE
• Southeast Asia – Myanmar, Vietnam, Philippines
• CIS Nations – Kazakhstan, Uzbekistan, Armenia

Export Services:

• International freight coordination (air and sea)
• Customs clearance documentation
• Pre-shipment inspection (SGS, Intertek, Bureau Veritas)
• Label compliance with importing country regulations
• Cold chain or temperature-sensitive logistics if needed

We manage the complete supply chain cycle from factory dispatch to client warehouse delivery.

Third-Party Manufacturing Process Workflow

1. Client Requirement Discussion
   • Formulation type, dosage strength, packaging preferences, target market
2. Quotation and Agreement
   • MOQs, pricing, delivery timeline, documentation scope
3. Sample Submission
   • Pilot batch for client review (if requested)
4. Artwork and Label Approval
   • Client-specific branding and regulatory compliance
5. Batch Production
   • GMP-compliant manufacturing with QA oversight
6. Quality Testing and Batch Release
   • CoA and test reports issued
7. Packing and Shipment
   • Coordinated dispatch with export and customs support

Lead Time: 30–45 working days post-approval of artwork and regulatory inputs

Ideal Client Profiles

Our Celecoxib manufacturing solutions are designed for:

• Pharmaceutical marketing companies in pain management
• Orthopedic and rheumatology-focused healthcare brands
• Government healthcare programs and tenders
• International drug distributors and NGOs
• Hospitals, clinics, and public health procurement
• OTC product lines and wellness brands

Advantages of Partnering with BluepillExpress

• WHO-GMP certified production facilities
• Comprehensive formulation, packaging, and documentation services
• Fast turnaround and low minimum order quantities
• Cost-effective manufacturing without compromising on quality
• Scalable manufacturing capabilities for domestic and export demands
• Transparent communication and end-to-end technical support
• Regulatory expertise for global dossier submission

Conclusion

Celecoxib remains a cornerstone of modern pain and inflammation management, offering potent anti-inflammatory relief with improved gastrointestinal safety. With increasing demand in orthopedics, women’s health, sports medicine, and chronic pain therapy, Celecoxib presents a lucrative opportunity for pharmaceutical companies looking to expand their pain management portfolios.

At BluepillExpress, we provide turnkey manufacturing solutions for Celecoxib, backed by technical expertise, international certifications, and flexible branding options. Whether you’re entering a new therapeutic market or scaling up existing operations, we are your trusted partner in pharmaceutical manufacturing.