Manufactured to
Exact Specification.
200,000 sq ft GMP facility. Fluid bed granulation through serialized packaging. Your molecule, our process discipline.
1.2 Billion
Doses Manufactured
Zero FDA 483s
Explore
§ Capabilities
06
Core Manufacturing
Platforms
From API receipt to serialized shipper — every unit operation validated, every batch record electronic.
Process Flow · DWG-MFG-001 Rev C
Fluid Bed Granulation
Top-spray and Wurster configurations for uniform particle size distribution. Handles hydrophilic and hydrophobic APIs with moisture-sensitive profiles.
Glatt GPCG 120
High-Shear Blending
Bin blending and V-blender configurations for free-flowing and cohesive powder systems. IBC transfer throughout to eliminate cross-contamination.
Bohle BFC 3000 IBC Blender
High-Speed Tablet Compression
250,000 units/hour throughput with in-process weight, hardness, and thickness monitoring. Tooling qualification to USP standards.
Korsch XL 800
Film & Enteric Coating
Aqueous and solvent-based film coating. Enteric, modified-release, and functional coatings. Color matching with CMC-ready color specifications.
O'Hara Labcoat III
Hard-Shell Encapsulation
Size 000 to 5 HPMC and gelatin capsules. Pellet, powder, and mini-tablet fills. Banding and liquid-fill capabilities for specialized formulations.
MG2 Futura
Serialization & Packaging
DSCSA-compliant aggregation and serialization. Blister, bottle, sachet, and pouch formats. Cold-chain qualified packaging lines available.
Marchesini Group MA 405
Supported Dosage Forms
Tablets
IR, ER, Enteric, ODT
Capsules
Hard-shell, Soft-gel
Sachets
Unit-dose powder fills
Liquid Fill
Oral solutions & suspensions
Pellets
Multi-unit particulate
Topicals
Semi-solid, ointments
§ Capacity
250K
Units Per Hour.
Validated Throughput.
Real-time equipment utilization. Q3 and Q4 2026 slots available for new programs. Campaign scheduling within 8 weeks of tech transfer completion.
Equipment Register · Rev 2026-02
| Equip. Code | Unit Operation | Manufacturer | Model | Rated Capacity | Utilization | Status |
|---|---|---|---|---|---|---|
| FBG-01 | Fluid Bed Granulator | Glatt | GPCG 120 | 10–200 kg batch | 72% | Available |
| FBG-02 | Fluid Bed Granulator | Freund Vector | FLO-120 | 10–120 kg batch | 85% | Committed |
| BLN-01 | IBC Bin Blender | Bohle | BFC 3000 | 3000 L / 1500 kg | 60% | Available |
| CMP-01 | Rotary Tablet Press | Korsch | XL 800 | 250,000 units/hr | 78% | Available |
| CMP-02 | Rotary Tablet Press | Fette | 4090i | 200,000 units/hr | 90% | Committed |
| CTG-01 | Coating Pan | O'Hara | Labcoat III 48" | 25–600 kg batch | 55% | Available |
| ENC-01 | Capsule Filler | MG2 | Futura | 180,000 caps/hr | 65% | Available |
| SRL-01 | Serialization Line | Marchesini | MA 405 | 400 bottles/min | 45% | Available |
Available Capacity Calendar · Manufacturing Lines 1–4
Q1 2026
Q2 2026
Q3 2026
↑ Slots available
Q4 2026
↑ Slots available
Campaign scheduling: 8-week lead time from signed MDA + tech transfer package
Request Capacity Hold§ Compliance
Zero.
FDA 483 Observations.
Since Day One.
Six inspections. Six NAIs. Our quality systems are built for inspection readiness every day — not just when FDA schedules a visit.
98.4%
Batch Right-First-Time Rate
Rolling 24-month average
100%
OOS Investigations Closed
Within 30-day CAPA target
0 Failures
Annual Product Reviews
Per 21 CFR 211.180(e)
14 Days
Change Control Cycle Time
Avg. minor change approval
Regulatory Register · QMS-REG-001
| Ref | Standard | Scope | Last Audit | Outcome |
|---|---|---|---|---|
| REG-01 | FDA 21 CFR Part 211 | cGMP for Finished Pharmaceuticals | Sep 2025 | NAI — No Action Indicated |
| REG-02 | ICH Q10 | Pharmaceutical Quality System | Ongoing | PQS Certified |
| REG-03 | ICH Q7 | API Manufacturing (Secondary) | Mar 2025 | VAI — Voluntary Action |
| REG-04 | DEA Schedule II–V | Controlled Substance Manufacturing | Jan 2026 | Licensed & Compliant |
| REG-05 | DSCSA 2023 Final Rule | Drug Supply Chain Security Act | Nov 2025 | Fully Compliant |
| REG-06 | ISO 15378:2017 | Primary Packaging Materials | Jun 2025 | Certified |
FDA Inspection History · 2018–2025
Facility commissioned; FDA pre-approval inspection
NAIFirst commercial batch release; DEA Schedule III license
CompliantFDA surveillance inspection — Sterile Prep expansion
NAIDSCSA Final Rule implementation; eBR system validation
CompliantICH Q10 PQS certification; ISO 15378 recertification
CertifiedFDA biennial surveillance inspection
NAICommon Quality & Regulatory Questions
Our facility has undergone six FDA inspections since commissioning in 2018 — four surveillance inspections and two pre-approval inspections. All have resulted in NAI (No Action Indicated) or VAI classifications. We have never received a Warning Letter or a Form 483 observation.
Yes. Our Tech Transfer team manages all aspects from API characterization, formulation feasibility, process development, scale-up, and validation. We have executed 34 tech transfers in the past three years with an average timeline of 16 weeks from signed MDA to first GMP batch.
We hold a DEA Schedules II–V manufacturing license. Our controlled substance suite operates under full access control with real-time inventory reconciliation. We currently manufacture four marketed DEA-scheduled products.
We provide a Certificate of Analysis (CoA), Certificate of Compliance (CoC), batch manufacturing records (eBR), in-process control data, and stability reports. All documentation is 21 CFR Part 11 compliant and available via our secure client portal within 5 business days of batch release.
§ Case Studies
34
Tech Transfers
Completed. On Time.
Across biotech Phase III programs, generic ANDAs, and nutraceutical launches — the same quality system, every program.
11 Wks
Scale-up to commercial validation
Mid-Stage Biotech
Arvana Therapeutics
Challenge
Phase III scale-up of moisture-sensitive HPMC capsule formulation. Previous CMO unable to maintain dissolution profile at 50 kg → 200 kg scale.
Solution
Reformulated granulation endpoint using NIR-guided moisture monitoring on Glatt GPCG 120. Validated 200 kg batch size in 11 weeks.
18 Mo
ANDA approval timeline
Generic Pharma House
Meridian Generic Pharma
Challenge
ANDA approval for extended-release metformin HCl 1000 mg tablet. Required 16-hour dissolution profile matching innovator product.
Solution
Hypromellose matrix system with Korsch XL 800 compression. Enteric coating via O'Hara pan. BE study passed on first attempt.
0.3%
OOS rate post-transfer
Nutraceutical
NutriCore Brands
Challenge
Vitamin D3 + K2 sachet with taste masking and stability at 40°C/75% RH. Previous supplier had 6-month OOS rate of 18%.
Solution
Fluid bed granulation with lipid coating for taste masking. Foil-laminate sachets with desiccant integration. ICH Q1B photostability validation.
Client Testimonials
Formulate's tech transfer team understood our molecule before we finished the briefing. The scale-up was textbook. First commercial batch: 99.8% release.
Dr. Priya Nair
VP CMC, Arvana Therapeutics
We've worked with five CMOs over twelve years. Formulate is the only one that's never given us a 483 concern, a batch failure, or a late shipment.
Robert Ellison
Director of Operations, Meridian Generic Pharma
Formulate's tech transfer team understood our molecule before we finished the briefing. The scale-up was textbook. First commercial batch: 99.8% release.
Dr. Priya Nair
VP CMC, Arvana Therapeutics
We've worked with five CMOs over twelve years. Formulate is the only one that's never given us a 483 concern, a batch failure, or a late shipment.
Robert Ellison
Director of Operations, Meridian Generic Pharma
§ Resource Library
04
Technical Briefs.
No Marketing Fluff.
Authored by our process engineers. Peer-reviewed against FDA guidance documents. Written for CMC teams, not procurement.
Primary CTA · Gated Asset
Download Our
Capabilities Deck
40-page technical overview including equipment specifications, process flow diagrams, quality system summary, regulatory history, and current capacity availability. Used by CMC teams during CMO qualification.
- Equipment register with model numbers & batch sizes
- Validated process parameters for 6 unit operations
- FDA inspection history & quality metrics
- Current capacity calendar Q1–Q4 2026
Technical Briefs · Ungated Access
Fluid Bed Granulation: Scale-Up & Endpoint Control
NIR-guided moisture endpoint determination, top-spray vs Wurster configuration selection criteria, and process analytical technology (PAT) integration for continuous monitoring.
Aqueous Film Coating: Enteric & Modified-Release
Polymer selection guide for pH-dependent release, coating weight gain targets, pan speed and airflow optimization, and troubleshooting sticking and picking defects.
DSCSA Serialization: Implementation Roadmap for CMOs
Step-by-step serialization compliance guide including GS1 DataMatrix commissioning, aggregation hierarchy, EPCIS event generation, and FDA verification router (VRS) integration.
Tech Transfer Playbook: Phase III to Commercial Scale
Process characterization requirements, critical quality attribute (CQA) mapping, design space documentation for regulatory submission, and validation strategy under ICH Q8/Q9/Q10.
Ready to discuss your program?
Our CMC team responds within one business day. NDA/CDA countersigned within 48 hours.