cGMP Facility • Texas
Texas nutraceutical manufacturing facility encapsulation and packaging cleanrooms viewed through architectural glass partition
Texas CDMO • 21 CFR Part 111 cGMP Manufacturing

Bring your supplement formula to market with a Texas manufacturing partner built for scale.

Micelle Nutraceuticals Labs delivers turnkey contract development and precision manufacturing in Carrollton and Van Alstyne, Texas. From custom formulation and pilot batch validation to high-speed encapsulation, powder blending, and full analytical release.

Carrollton & Van Alstyne, TX Facilities21 CFR Part 111 cGMP CompliantFull Lot Certificate of Analysis (COA)
Operational ParametersVerified Texas Production Capabilities
Facility Footprint
0+
Sq. Ft. Carrollton HQ & Analytical Lab
Controlled Space
0
Sq. Ft. Dedicated ISO 7/8 Cleanrooms
Active Identity
100%
FTIR/NIR Inbound Raw Material Quarantine
Compliance Code
Part 111
FDA 21 CFR Dietary Supplement cGMP
Secondary Campus: Van Alstyne, TXFacility Tour
Production Infrastructure

Calibrated cleanroom environments engineered for formula stability.

Our Texas manufacturing suites maintain strict particulate, humidity, and temperature standards to ensure complete label claim stability and regulatory compliance.

Micelle Nutraceuticals Labs ISO Class 7 cleanroom suite with automated encapsulation and packaging lines in Texas
Facility Record // Carrollton, TX Campus
Automated High-Speed Encapsulation & Bottling Cleanroom
ISO Class 7 primary suites with terminal HEPA filtration and positive pressure airflow.

High-Speed Encapsulation

Two-piece HPMC vegetarian and bovine gelatin capsules (sizes 00, 0, 1, 2) with automated weight verification.

Sanitary 316L Powder Blending

High-shear micro-blending in humidity-controlled suites (<20% RH) for uniform dispersion and instantization.

In-House Analytical Release

HPLC active potency confirmation, FTIR raw material assays, and ICP-MS heavy metals testing before lot shipment.

Compliance Bottling & Kitting

Automated counting, induction sealing, tamper-evident neck bands, and 21 CFR 101.36 label application.

Core CDMO Services

Integrated manufacturing capabilities from raw ingredient to shelf.

Eliminate fragmented vendor handoffs. Micelle Nutraceuticals Labs unifies R&D formulation, cleanroom production, compliance packaging, and analytical release under one audited standard in Texas.

01R&D & Flavor Chemistry

Custom Formulation & Taste Masking

Pilot benchtop prototypes • Excipient compatibility testing

In-house Texas formulation chemists optimize active ingredient bioavailability, stability, and proprietary flavor profiles. Natural taste masking eliminates bitterness from botanical extracts and mineral chelates.

Benchtop pilot samples
Natural botanical flavor systems
Liposomal & micellar carriers
Stability testing
02Solid Oral Dosage

Encapsulation & Tablet Compression

Sizes 00, 0, 1, 2 • Up to 150k caps/shift • USP <701>

Automated rotary encapsulation and precision tablet compression lines operating within dedicated ISO Class 7 cleanrooms. Every lot undergoes weight uniformity testing and USP disintegration verification.

Vegetarian HPMC & gelatin capsules
Beadlet & micro-pellet fills
Scored & chewable tablets
Delayed-release enteric film coating
03Specialty Blending

High-Shear Powder Blending

RSD < 3% blend uniformity • Desiccant RH control

Sanitary 316L stainless steel ribbon and twin-shell V-blenders operating in climate-controlled suites (<20% RH). Engineered for sports nutrition, hydration electrolytes, greens, and instantized proteins.

Hydration & electrolyte drink mixes
Instantized whey & plant proteins
Pre-workout & nootropic blends
Single-serve stick packs & multi-serve jars
04Liquid Formulations

Liquid Manufacturing & Tinctures

USP purified water loop • In-line filtration

Advanced liquid compounding in pharmaceutical-grade mixing vessels with multi-pass USP purified water loop. Calibrated filling for sublingual drops, botanical extracts, and oral liquid suspensions.

Sublingual drops & oral tinctures
Nano-emulsions & micellar solutions
Amber glass & PET bottle packaging
Calibrated dropper & metered pump capping
05Packaging & Logistics

Turnkey Packaging & Fulfillment

Multi-lane stick packs • Induction sealing • Texas dispatch

Automated high-speed packaging lines with optical tablet/capsule counting, induction foil hermetic sealing, tamper-evident neck bands, and FDA 21 CFR 101.36 supplement facts label compliance review.

Automated bottle filling & capping
Multi-lane flexible stick packaging
Stand-up gusset pouches & sachets
Multi-SKU kitting & nationwide freight dispatch
Independent Quality Unit on Every Production Run
21 CFR 111.103 compliance: Our QA team maintains absolute stop-work authority on all manufacturing suites.
Review Quality Manual
Primary Dosage Formats

Delivery forms engineered to verified USP monographs.

Every dosage format is manufactured in dedicated cleanrooms and validated for dissolution rate, active potency retention, and organoleptic stability.

Explore All 4 Monograph Hubs
Two-piece vegetarian HPMC capsules filled with golden botanical micro-beadlets
FIG. 01 // HPMC VEGGIE CAPSULES
Solid Oral Dose•USP <701> Disintegration

HPMC Vegetarian & Gelatin Capsules

Precision rotary-filled two-piece vegetarian HPMC and bovine gelatin capsules. Formulated for dry powder blends, botanical extracts, and time-released micro-beadlets.

Quality Release Tolerances
Disintegration < 15 min (USP <701>)
Fill weight tolerance ±3%
Available sizes: 000, 00, 0, 1, 2
Delayed-release enteric options
Packaging Compliance: Packaged in HDPE or amber glass bottles with induction foil hermetic seal.
Up to 150k caps/shift • Weight ±3%View Delivery Form Specifications
Analytical Quality & Compliance

21 CFR Part 111 cGMP compliance with every production lot.

Every dietary supplement produced at our Carrollton, Texas facility is released only after passing comprehensive identity, potency, heavy metal, and microbiological assays backed by an analytical Certificate of Analysis (COA).

Quarantine Release01

Raw Material Identity (FTIR & NIR)

100% of inbound active botanicals, minerals, and vitamins are quarantined and verified against pharmacopeial reference standards before batch blending.

Trace Metals Assay02

Heavy Metals Contaminant Screen (ICP-MS)

Inductively Coupled Plasma Mass Spectrometry quantifies Lead, Arsenic, Cadmium, and Mercury down to parts-per-billion (ppb) limits per California Prop 65 & USP standards.

Label Claim Verification03

Finished Potency Verification (HPLC / UPLC)

High-Performance Liquid Chromatography confirms active nutrient concentrations match or exceed label claims through product shelf-life.

Bioburden Safety04

Microbiological Testing (USP <2021> / <2022>)

Screening for Total Aerobic Microbial Count (TAMC), Yeast & Mold (TYMC), Salmonella spp., Escherichia coli, and Staphylococcus aureus.

Micelle Nutraceuticals Labs analytical chemistry lab with High-Performance Liquid Chromatography (HPLC) for potency testing
On-Site Analytical QAHPLC Potency & FTIR Inbound Testing • Carrollton, TX
Federal Regulation
FDA 21 CFR Part 111
Dietary Supplement cGMP
Facility Status
FDA Registered
Active federal registration
Athletic Readiness
NSF for Sport Ready
Banned substance protocols
Batch Release
Finished Lot COA
Issued with every shipment
Client Engagement Roadmap

A transparent six-stage manufacturing process.

From initial formula scoping to commercial warehouse dispatch, every milestone is structured with clear technical sign-offs, regulatory checks, and verified deliverables.

01
Intake & Discovery

Formula Scoping & Mutual NDA

Initial intake to evaluate formula specifications, target label claims, active ingredient sourcing, and batch volume requirements under mutual non-disclosure.

Verified Milestone Output
Formulation Feasibility Review & Pricing Model
02
R&D Chemistry

Benchtop Formulation & Taste Optimization

In-house Texas chemists engineer benchtop prototype batches, optimize dissolution profiles, and develop proprietary natural taste-masking systems.

Verified Milestone Output
Physical benchtop prototype samples for client review
03
Quality Quarantine

Raw Material Qualification

100% of inbound active ingredients and botanicals are quarantined and verified via FTIR identity assay and ICP-MS heavy metals testing before production.

Verified Milestone Output
Raw Material Release Certificate on file
04
Production Run

cGMP Cleanroom Manufacturing

Precision automated encapsulation, rotary tablet compression, or sanitary 316L powder blending in ISO 7 suites with in-process weight checks every 15 minutes.

Verified Milestone Output
Complete Batch Production Record (BPR)
05
Laboratory Release

Analytical Testing & COA Release

Finished lot undergoes active potency assays (HPLC/UPLC), USP <2021>/<2022> microbiological culture screens, and physical disintegration testing.

Verified Milestone Output
Certified Finished Product Certificate of Analysis (COA)
06
Logistics Dispatch

Packaging, Labeling & Freight Dispatch

Automated induction-sealed bottle packaging or multi-lane stick packing, 21 CFR 101.36 label review, retail kitting, and nationwide freight dispatch from Texas.

Verified Milestone Output
Shelf-ready commercial inventory & BOL documentation
Have an existing formulation or formula brief? Our Texas technical team can review your bill of materials (BOM) under mutual NDA within 24 business hours.
Request Formulation Review
Direct Engineering & Formulation Access

Tell us what you are building.

Whether you are formulating a new dietary supplement concept, expanding an existing product line, or transferring manufacturing to an audited Texas cGMP facility, our formulation chemists and production engineers will evaluate your technical requirements.

Carrollton & Van Alstyne, TX(844)-323-562821 CFR Part 111 cGMP
What to Expect
Quote Intake & Technical Review
Helpful information for an accurate quote:
Desired dosage form (Capsules, Powders, Tablets, Liquids)
Active ingredient formula brief or target label claims
Target pilot or commercial batch volume (MOQ: 1,000 units)
Packaging format (Bottles, stick packs, gusset pouches)
Response SLATechnical review within 1 business day under mutual NDA. Preliminary feasibility & pricing within 48–72 hours.
Mutual NDA executed upon requestIP Policy