Gelatin Capsule Manufacturer
Gelatin Capsule Manufacturer USA | Advanced Supplements
Advanced Supplements is a US-based gelatin capsule manufacturer providing hard gelatin capsule production for pharmaceutical, nutraceutical, and private label brands. Our GMP-certified, FDA-registered facility handles gelatin capsule manufacturing from empty capsule shell production through filling, finishing, and labeling. Whether you need two piece gelatin capsule manufacturing at pilot scale or high-volume commercial runs, our team manages the full process from formulation through fulfillment.
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Leading Gelatin Capsule Manufacturing Company in the USA
Leading Gelatin Capsule Manufacturing Company in the USA
Advanced Supplements operates a dedicated gelatin capsule manufacturing facility in the United States, producing two-piece hard gelatin capsules across a full size range from size 00 to size 4. We serve pharmaceutical brands, nutraceutical companies, private label supplement businesses, and contract manufacturing customers who need consistent, fully documented production.
Our gelatin capsule production lines handle both pharmaceutical and nutraceutical applications, with separate process controls for bovine, porcine, and fish gelatin sources. Each source carries documented traceability, and every batch includes certificates of analysis covering identity, purity, moisture content, and microbiological criteria.
As a gelatin capsule manufacturer USA partner, we support customers from concept through commercial launch. Our team assists with capsule specification selection, fill weight development, stability planning, and regulatory documentation. We work with brands seeking a reliable gelatin capsule contract manufacturer for ongoing production as well as companies launching new products for the first time.
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Complete Custom Gelatin Capsule Contract Manufacturing Services
Our gelatin capsule contract manufacturing services cover the full production scope, including custom gelatin capsule formulation, gelatin capsule filling services, gelatin capsule encapsulation, finishing, and packaging. We operate as a single point of contact from raw material qualification through finished goods delivery.
We produce filled gelatin capsules in multiple fill formats: powder filled gelatin capsules, liquid filled gelatin capsules, and pellet filled gelatin capsules. Each fill type follows validated procedures with documented fill weight accuracy. Our gelatin capsule encapsulation services support both standard formulations and proprietary blends developed in our R&D lab.
Customers choosing gelatin capsule toll manufacturing retain full ownership of their formulations, protected under standard confidentiality agreements. For brands needing finished goods assembly, our gelatin capsule co-packing service covers bottling, labeling, and bulk packaging. Our capacity scales from small market test batches to full commercial volume.
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Gelatin Capsule Formats and Fill Types We Produce
We manufacture two-piece hard gelatin capsules in a range of fill configurations, gelatin sources, and capsule sizes to fit different product and market requirements. Our encapsulation lines handle pharmaceutical and nutraceutical formulations with validated filling equipment and in-process weight checks at regular intervals.
Hard Shell Two-Piece Gelatin Capsule
Two piece gelatin capsules are the most widely used encapsulation format in pharmaceutical and nutraceutical manufacturing. Our hard shell gelatin capsule manufacturing covers sizes 00 through 4 and supports bovine, porcine, and fish gelatin shells. Each capsule size carries a documented fill volume capacity, and our filling equipment delivers consistent fill weights within validated tolerances. We source empty capsule shells from approved suppliers with complete certificates of analysis.
Powder Filled Gelatin Capsules
Powder filled gelatin capsules are the standard format for dry botanical extracts, vitamins, minerals, and proprietary blends. Our powder encapsulation process uses validated filling machines calibrated to target fill weights with documented accuracy. Blending takes place in humidity-controlled rooms appropriate to the formulation. Each batch is tested for fill weight uniformity, capsule integrity, and ingredient identification before release.
Liquid Filled Gelatin Capsules
Liquid filled gelatin capsules support oil-based formulations, lipophilic actives, and suspensions requiring a liquid or semi-solid fill. Our liquid filling process uses temperature-controlled equipment with validated fill weight procedures. This format is used for omega-3 oils, fat-soluble vitamins, herbal extracts in carrier oils, and similar preparations. Capsule seal integrity and visual quality are confirmed on each production batch.
Pellet Filled Gelatin Capsules
Pellet filled gelatin capsules hold multi-particulate pellet systems, including enteric-coated pellets, sustained-release pellets, and immediate-release pellet blends. This fill type supports modified-release profiles without tableting. Our pellet encapsulation service handles a range of pellet sizes and densities, with fill weight and pellet count verified during production. This format is commonly used in pharmaceutical gelatin capsule manufacturing for controlled delivery applications.
Delayed Release Gelatin Capsules
Delayed release gelatin capsules are designed to pass through the stomach intact and release their contents in the intestine. We produce these using capsule-level enteric coatings applied after standard filling and sealing. Applications include acid-sensitive enzymes, probiotics, and botanical actives that degrade in low-pH environments. Coated capsules are tested against USP disintegration criteria in both simulated gastric and intestinal fluid conditions.
Enteric Coated Gelatin Capsules
Enteric coated gelatin capsules carry an acid-resistant polymer coating that prevents dissolution in gastric fluid. Our coating process uses validated aqueous enteric coating systems meeting USP and Ph. Eur. disintegration specifications. We confirm coating performance through in-process disintegration testing in simulated gastric fluid and then dissolution testing in intestinal fluid conditions. This format is widely specified in pharmaceutical gelatin capsule manufacturing for gastroprotective delivery.
Empty Gelatin Capsule Manufacturing
We supply empty gelatin capsules to customers operating their own filling equipment or requiring shells for in-house production. Empty capsules are available in standard sizes from 00 to 4 in bovine, porcine, and fish gelatin. All shells are supplied with full documentation including moisture content, dimensions, disintegration data, and supplier certificates. Bulk quantities are available in packaging formats suited to in-house handling workflows.
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Gelatin Capsule Production Capacity and Scale
Gelatin Capsule Production Capacity and Scale
Our production facility scales from small validation batches to full commercial volume, supporting gelatin capsule manufacturing at every stage of brand growth. We run multiple encapsulation lines capable of handling powder, liquid, and pellet fills on dedicated, separately validated equipment.
Minimum order quantities are set to support market testing without excess inventory commitment, and we offer volume pricing tiers as production scale increases. Our production planning team works with each customer on manufacturing schedules aligned with their launch timeline and inventory requirements.
For brands managing seasonal demand or faster-than-expected growth, our facility accommodates short-lead production runs alongside standing scheduled orders. All production takes place in our US-based GMP-certified gelatin capsule facility with full batch traceability from raw material receipt through finished goods shipment.
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Why Work With Our Gelatin Capsule Manufacturing Facility?
Selecting a gelatin capsule manufacturer involves more than comparing unit prices. Consistent product quality, regulatory compliance, and supply reliability determine whether your product performs in the market and stays on the shelf. Here is what clients find when they work with us.
GMP Certified Gelatin Capsule Manufacturer
Our facility holds GMP certification under 21 CFR Part 111 for dietary supplements and follows current Good Manufacturing Practice standards for pharmaceutical applications. Our quality systems cover incoming material testing, in-process controls, environmental monitoring, equipment calibration, and batch record review. As a GMP certified gelatin capsule manufacturer, we maintain audit-ready documentation for every production batch
FDA Registered Manufacturing Facility
Our manufacturing site is registered with the US Food and Drug Administration as an FDA registered gelatin capsule facility. Registration is current and maintained through annual renewal. We produce under conditions that support both dietary supplement and pharmaceutical grade applications, and we maintain documentation required for FDA inspections, third-party audits, and customer quality agreements.
Pharmaceutical Grade Standards
Pharmaceutical grade gelatin capsules require stricter specifications than standard nutraceutical production, including tighter limits on moisture content, dimensional tolerances, disintegration time, and microbiological criteria. We produce pharmaceutical grade gelatin capsules meeting USP and Ph. Eur. monograph requirements and supply full analytical documentation with each batch. Both hard gelatin and enteric-coated formats are available at pharmaceutical grade specifications.
Halal and Kosher Certified Gelatin Capsules
Religious dietary compliance is a firm requirement in many consumer markets. We offer halal certified gelatin capsules sourced from halal-slaughtered bovine or fish gelatin, with third-party halal certification documentation for each lot. Our kosher certified gelatin capsules are supported with current kosher certification from recognized certification bodies. BSE free gelatin capsules produced from bovine sources carry TSE/BSE-free declarations with supporting supplier documentation.
Custom Gelatin Capsule Formulation
Our formulation team supports custom gelatin capsule formulation from concept through validated production. We assist with active ingredient selection, excipient compatibility assessment, fill weight targeting, and stability protocol design. Formulations developed in our facility are protected by confidentiality agreements, and you retain full ownership of your formula. We serve both pharmaceutical gelatin capsule manufacturer clients requiring pharmacopeial compliance and nutraceutical gelatin capsule manufacturer clients building branded supplement products.
Toll Manufacturing and Co-Packing
We support customers who own their formula and need gelatin capsule toll manufacturing using their supplied materials or ingredients purchased through our procurement network. Our toll manufacturing program covers receiving, testing, encapsulation, and return shipment of finished capsules. For brands needing retail-ready products, our gelatin capsule co-packing service handles bottle filling, labeling, capping, and case packing, all under standard quality agreements with full batch documentation.
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Our Gelatin Capsule Manufacturing Process
Every production run follows a documented process delivering consistent fill weights, confirmed capsule integrity, and complete batch traceability. The steps below describe how we manage a standard gelatin capsule manufacturing project from intake through shipment.
Project Assessment
We begin by reviewing your product specification, including capsule size, fill type, gelatin source, certification requirements, and target production volume. Our production and quality teams identify any testing, documentation, or sourcing requirements specific to your market before production is scheduled.
Formula and Specification Development
For new formulations, our team develops and validates the blend specification, fill weight target, and capsule size selection. For supplied formulas, we conduct a technical review and confirm compatibility with our filling equipment and quality standards before committing to a production timeline.
Gelatin Source and Material Sourcing
We source gelatin capsule shells and fill ingredients from qualified suppliers holding current certificates of analysis. Gelatin source selection, whether bovine, porcine, or fish, is confirmed at this stage along with any certification requirements such as halal, kosher, or BSE-free documentation.
Incoming Quality Testing
All raw materials and empty capsule shells pass incoming quality testing before entering production. Testing covers identity confirmation, purity, moisture content, and microbiological limits. Materials that do not meet specification are held and not released to production until disposition is completed through our quality review process.
Pilot Batch and Validation
Before commercial production, we run a pilot batch to confirm fill weight accuracy, capsule integrity, blend homogeneity, and process parameters. Pilot data supports process validation documentation and provides customers with early samples for review before full-scale production begins.
Commercial Capsule Production
Commercial production runs under documented conditions with in-process weight checks at defined intervals. Environmental conditions, equipment settings, operator records, and line clearance documentation are captured in batch records. Finished capsules undergo visual inspection and sampling for final release testing.
Final Quality Release and Packaging
Finished gelatin capsules pass final quality release testing covering fill weight, appearance, disintegration, and identity before packaging. Our packaging team handles bottle filling, labeling, induction sealing, and case packing under documented procedures. A certificate of analysis is issued with every shipment.
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Private Label Gelatin Capsules and Custom Packaging
A complete private label gelatin capsules program covers more than encapsulation. Our service manages formulation, capsule source selection, packaging compliance review, and fulfillment so your brand reaches market with a finished, fully documented product.
Custom Formulation Development
We develop proprietary blends for private label clients across pharmaceutical and nutraceutical categories. Our custom gelatin capsule formulation service covers botanical extracts, vitamins and minerals, enzymes, probiotics, and combination formulas. Each formulation is developed to your target specification, tested for compatibility and stability, and protected under confidentiality agreement. You retain full ownership of the formula.
Capsule Size Selection
Capsule size determines fill volume and consumer experience. We produce private label gelatin capsules in all standard sizes: size 00 gelatin capsule for high-volume fills, size 0 gelatin capsule for standard doses, and sizes 1 through 4 for smaller fill weights and pediatric-adjacent applications. Our technical team recommends the appropriate size based on bulk density and the target dose per capsule.
Gelatin Source Selection
Gelatin source affects your target market acceptance and certification path. We offer bovine gelatin capsule manufacturer services for standard North American products, porcine gelatin capsule manufacturer options where cost is the primary driver, and fish gelatin capsule manufacturer services for halal markets or consumers avoiding land-animal sources. Beef gelatin capsule manufacturer production carries BSE-free and halal documentation options depending on the sourcing specification selected.
Label and Packaging Design Support
Our team reviews supplement facts panels, ingredient declarations, and structure-function claims for regulatory compliance before your labels are finalized. We work with your graphic designer or can connect you with packaging specialists for full label development. Packaging options include stock bottles with custom labels, printed containers, and bulk formats for downstream co-packing workflows.
Co-Packing and Fulfillment
Our gelatin capsule co-packing service handles finished goods assembly for retail and e-commerce distribution. We manage bottle filling, label application, capping, lot coding, and case packing. Fulfillment services are available for brands shipping to Amazon FBA warehouses, third-party logistics providers, or retail distribution centers.
Multi-SKU and Product Line Development
Brands building a full supplement line can develop multiple SKUs through our facility with shared documentation infrastructure and coordinated production scheduling. We support line extensions across different capsule sizes, gelatin sources, or dose strengths without duplicating formulation development costs. This structure helps brands serve broader consumer segments within a single manufacturing relationship.
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Success Speaks Louder
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Frequently Asked Questions
Frequently Asked Questions
Yes. Advanced Supplements produces vegan sports nutrition using 100% plant-sourced inputs, keto formulas with no maltodextrin or high-glycemic fillers, and clean label productions using only recognizable naturally sourced excipients. Paleo, sugar free, allergen free, and organic sports supplement programs are also available.
Start Your Gelatin Capsule Project
Our production team handles gelatin capsule manufacturing from formulation through finished goods. We work with pharmaceutical brands, nutraceutical companies, and private label businesses across the United States, managing capsule source selection, filling, quality documentation, and packaging under one manufacturing agreement.
Contact us to discuss your capsule size, fill type, gelatin source, and volume requirements. We follow up within one business day with a project assessment and quote based on your specification.
- Trusted by 1,650+ Private Label Companies, Suppliers & Manufacturers
