Uncompromising Quality Assurance
Site audits, specification control, and documented release criteria applied before a single unit carries a partner's label.
Private Label Pharmaceutical & Custom Formulation Solutions
Delivering High-Quality Private Label Pharmaceuticals
Trusted partnerships connecting world-class manufacturing excellence with rigorous U.S. regulatory standards and reliable domestic distribution.
Capability Summary
B2B / RX & OTC- Dosage-form platforms
- Oral solids · Ophthalmic · Topicals
- Therapeutic franchises
- 6 represented in prior label portfolio
- Manufacturing lineage
- WHO-GMP certified sites
- Engagement models
- Private label · Custom formulation
- Distribution
- U.S. domestic network
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cGMP
Current Good Manufacturing Practice
Partner sites qualified against 21 CFR 210/211 expectations.
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Traceability
Batch-Level Chain of Custody
Lot genealogy from API sourcing through domestic release.
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Analytics
Independent Release Testing
Identity, assay, dissolution and stability verification.
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Continuity
Multi-Site Supply Redundancy
Qualified alternates to protect against single-source risk.
Who We Are
A forward-thinking partner for value-driven generic pharmaceuticals
Labigenix LLC builds and operates private label pharmaceutical programs for U.S. distributors, retail and institutional pharmacy groups, and healthcare brands. We sit between proven global manufacturing capacity and the American market — translating formulation capability into compliant, commercially viable product lines.
Our team originates from hands-on commercialization work across multi-franchise generic portfolios: oral solids, anti-infectives, hematinics, bone-health therapy and antioxidant nutraceuticals. That operating experience shapes how we qualify sites, structure supply agreements, and protect continuity for our partners.
Regulatory Rigor
Dossier readiness, labeling compliance, and change-control discipline aligned to FDA expectations for the U.S. market.
Global Manufacturing Network
Established relationships with qualified facilities across leading production hubs, selected on capability rather than cost alone.
Supply Chain Integrity
Forecast-linked planning, buffer strategy, and transparent lead times that keep shelves stocked and commitments intact.
Product Portfolio
Capability across three formulation platforms
Our sourcing programs are built around manufacturing platforms our team has commercialized before — with therapeutic breadth spanning chronic care, acute care, and specialty presentations.
High-volume tablets and capsules
Immediate-release and sustained-release tablets, film-coated and dispersible presentations, hard-gelatin capsules, and dry powder for oral suspension — covering major chronic and acute care therapeutic classes at commercial scale.
- Single-entity and fixed-dose combination products
- Blister, strip, and HDPE bottle configurations
- Dissolution and stability profiling per ICH conditions
Therapeutic classes commercialized
Gastroenterology
Proton pump inhibitors + prokinetic combinations
Anti-Infectives
Beta-lactam + inhibitor; quinolone + nitroimidazole
Pain & Inflammation
NSAID · analgesic · enzyme combinations
Hematinics
Chelated iron, folate, B12 and zinc therapy
Bone & Metabolic Health
Calcium, calcitriol, vitamin D3 and K2-7
Antioxidant & Nutraceutical
CoQ10, carotenoids, omega-3 and trace minerals
Precision eye drops and specialized presentations
Sterile ophthalmic solutions and suspensions produced under aseptic conditions — including multi-dose preserved formats, preservative-free unit-dose vials, and specialized diagnostic and therapeutic drop portfolios.
- Aseptic fill-finish with validated sterile filtration
- Container closure integrity and extractables assessment
- Tonicity, pH and viscosity control per batch
Presentation categories
Diagnostic Drops
Mydriatics, cycloplegics, topical anesthetics
Anti-Infective Ophthalmics
Antibiotic and antibiotic-steroid combinations
Ocular Surface Therapy
Lubricants and preservative-free unit-dose
Anti-Glaucoma
Prostaglandin analogues and beta-blocker solutions
Anti-Allergic
Antihistamine and mast-cell stabilizer drops
Otic & Nasal Specialty
Adjacent sterile drop and spray formats
Creams, ointments and gels built for stability
Semi-solid dosage forms manufactured for consistent rheology, uniform active distribution, and reproducible batch-to-batch performance — supported by accelerated and long-term stability programs.
- Emulsion stability and viscosity specification control
- Laminate tube, jar and pump-dispenser packaging
- Content uniformity verified across fill sequence
Formulation categories
Corticosteroid Topicals
Low to high potency creams and ointments
Antifungals
Azole and allylamine cream presentations
Topical Antibacterials
Wound care and dermal infection ointments
NSAID Gels
Musculoskeletal pain and inflammation relief
Keratolytics
Salicylic and urea-based dermatological therapy
Dermo-Cosmetic
Barrier repair, emollient and OTC skin care lines
Therapeutic classes shown reflect prior-label commercialization experience of the Labigenix team. Product availability is program-specific and confirmed during partner qualification.
Quality & Regulatory Standards
Compliance is the product
In private label pharmaceuticals, a partner inherits your quality posture. We structure every program so that documentation, testing, and traceability hold up under scrutiny.
FDA-Regulated Standards
Products are manufactured in facilities operating to stringent current Good Manufacturing Practice guidelines, with quality systems designed to withstand regulatory inspection.
- 21 CFR 210 / 211 alignment
- Validated processes and cleaning
- Documented change control
Supply Chain Resilience
End-to-end traceability, rigorous batch testing, and logistics planning that anticipates demand shifts rather than reacting to them.
- API-to-finished-lot genealogy
- DSCSA-ready serialization data
- Qualified alternate sourcing
Partnership Integrity
Transparent pricing, honest lead times, and long-term B2B relationships. We tell partners what we can deliver, then deliver it.
- Defined quality agreements
- Open capacity and lead-time reporting
- Confidentiality and IP protection
Contact
Connect With Our Team
For private label distribution opportunities, custom formulations, and partnership inquiries, reach out directly at info@labigenix.com.
What to expect
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1
Initial response within two business days
A member of our commercial team reviews your requirement.
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2
Capability and feasibility review
We confirm dosage form, volume, and regulatory pathway.
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3
Program proposal and quality agreement
Commercial terms, timelines, and documentation scope.
Thank you. Your inquiry has been submitted.
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