Benuvia Manufacturing

What Benuvia Manufacturing does

Benuvia Manufacturing is a US-based specialty Contract Development and Manufacturing Organization (CDMO) and active pharmaceutical ingredient (API) supplier focused exclusively on controlled substances. Founded in 2020 and headquartered at 3950 N. Mays Street in Round Rock, Texas, the company operates an 83,000 square foot DEA-authorized facility capable of handling Schedules I-V controlled substances including cannabinoids, psychedelics, and traditional small-molecule pharmaceuticals. The company is structured as Benuvia Operations, LLC, is privately held, and operates with 51-100 employees.

The company's offering is built on a unified services platform comprising six integrated modules: API process development, analytical development, formulation development, manufacturing services, regulatory services, and commercial services. Layered on top are four specialized programs — Discovery Booster, Clinical Expressway, Market Accelerator, and Stability Solutions — that bundle platform capabilities for specific development phases from early discovery through commercial market entry. The company reports 500+ successful FDA submissions and $50M+ invested in infrastructure, signaling multi-year operational maturity despite the 2020 founding date.

The business model is project-based CDMO services with custom quotations tied to scope, volume, complexity, and development phase; pricing is not publicly disclosed. Go-to-market is enterprise-direct via a VP of Commercial & Business Development supported by account executives, with marketing leverage through industry conferences (CPHI North America, CPHI Europe, Contract Pharma, AAPS PharmSci 360), a Knowledge Center of case studies and whitepapers, and strategic partnerships. Customer base spans pharmaceutical companies, biotechnology firms, academic and research institutions, and government research programs, with named engagements including Mandara Biopharma (FDA IND filing for Dronabinol Oral Solution in Alzheimer's Agitation), Khona Scientific (biosynthetic controlled-substance API development), Mikart (finished drug product manufacturing co-marketing), and Cannovation Clinical Research Partners (clinical research integration).

Name

Benuvia Manufacturing

Legal name

Benuvia Operations, LLC

Website

https://benuviamanufacturing.com

Company type

Private

Founded year

2020

Operating status

Operating

Headcount range

51–100 employees

Short description

Benuvia Manufacturing is a US-based specialty CDMO providing end-to-end API development, formulation, analytical, and manufacturing services for Schedules I-V controlled substances, including cannabinoids and psychedelics, serving pharmaceutical and biotechnology clients from its DEA-authorized Round Rock, Texas facility.

Ownership category

akta.pro rank

Product category

Pharmaceutical CDMO Services

NAICS

Pharmaceutical and Medicine Manufacturing (3254), Pharmaceutical Preparation Manufacturing (325412)

SIC

Pharmaceutical Preparations (2834), Medicinal Chemicals & Botanical Products (2833)

akta.pro primary industry

Drug Substance–Drug Product Integrated CDMO (HLAGABAG)

akta.pro secondary industries

Small-Molecule API & Intermediates CDMO (HLAGABAA), Small-Molecule Drug Product (Solid/Oral/Parenteral) CDMO (HLAGABAB), Clinical Trial Material (CTM) Manufacturing & Supply CDMO (HLAGABAK)

Keywords

• Controlled substance CDMO
• Active pharmaceutical ingredient
• Drug product manufacturing
• Pharmaceutical contract development
• Schedule I-V narcotics

Headquarters

HQ city

Round Rock

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Infrastructure, Supply Chain, Technology or R&D, Operations, Marketing or Sales

Revenue model

1. Contract Development and Manufacturing Organization (CDMO) Services: Full-service CDMO providing end-to-end drug development and manufacturing services for controlled substances and small molecules. Revenue generated through project-based contracts for API synthesis, analytical services, formulation development, manufacturing, regulatory consulting, and commercialization support. Services range from early-phase discovery through commercial production.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels5 records

Core offering

Benuvia Manufacturing is a US-based Contract Development and Manufacturing Organization (CDMO) that provides end-to-end drug development and manufacturing services for controlled substances. The company specializes in API synthesis, analytical development, formulation development, manufacturing, regulatory services, and commercialization for Schedules I-V narcotics including cannabinoids, psychedelics, and traditional pharmaceuticals. It operates from an 83,000 sq ft DEA-authorized facility in Round Rock, Texas, and has completed over 500 FDA submissions.

Product overview

Benuvia operates as a US-based specialized Contract Development and Manufacturing Organization (CDMO) and API supplier offering a unified services platform plus specialized solutions for controlled substances. The unified services platform includes six integrated modules: API Process Development, Analytical Development, Formulation Development, Manufacturing Services, Regulatory Services, and Commercial Services. These services are designed to work together under one roof, enabling IND-enabling capabilities from concept through market. The specialized solutions programs—Discovery Booster, Clinical Expressway, Market Accelerator, and Stability Solutions—provide end-to-end integrated approaches tailored for discovery, clinical trial, and market advancement phases. The company handles controlled substances including Schedules I-V narcotics, cannabinoids, psychedelics, and small molecules, with over 500 successful FDA submissions.

Differentiator

Problem solved

Functional benefit

Brands

• Discovery Booster: Accelerates path to molecule with tailored solutions, advanced technologies, and expert guidance for drug discovery.
• Clinical Expressway
• Market Accelerator
• Stability Solutions
• Unified Services Platform

Products and services

• Unified Services Platform

Quantifiable outcome

• 500+ FDA Submissions
• +2 more outcomes

Named customers3 records

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature9 records

Partnerships

Four partnerships are on record, tiered core.

• MikartcoreGTM or Marketing Partner · 23 April 2026Strategic co-marketing partnership to deliver end-to-end controlled substance development and finished drug product manufacturing. Combines Benuvia's API synthesis and controlled substance expertise with Mikart's finished drug product manufacturing capabilities.
• Mandara BiopharmacoreStrategic or Co-development Partner · 12 January 2026Benuvia Operations supported FDA IND filing for Mandara Biopharma's Dronabinol Oral Solution for Alzheimer's Agitation. Regulatory and development services partnership.
• Khona ScientificcoreStrategic or Co-development Partner · 7 January 2026Letter of Intent signed to advance biosynthetic development of controlled-substance APIs. Joint development effort focused on innovative biosynthetic approaches to controlled substance manufacturing.
• Cannovation Clinical Research PartnerscoreStrategic or Co-development Partner · 3 December 2025Strategic partnership to deliver fully integrated solutions for controlled-substance therapeutics. Combines clinical research expertise with manufacturing capabilities for streamlined development pathways.

Scale indicators4 records

Recent moves5 records

Expansion highlights5 records

Direct peers

• Alcami Corporation: US-headquartered CDMO of comparable scale offering API development, formulation, analytical and commercial manufacturing services including controlled substance handling. Closely mirrors Benuvia's integrated services structure and customer base.
• Hovione: Specialty contract manufacturer focused on small molecule APIs and drug products, with strong process development and high-potency capabilities. Similar mid-size CDMO profile serving pharma innovators.
• Noramco: Specialty API manufacturer with deep expertise in controlled substances (including narcotics and cannabinoids), supplying drug substance to pharma customers globally. Highly comparable niche focus on schedule-controlled API synthesis.
• PCI Synthesis: US-based small molecule API and process development CDMO serving biotech and pharma customers. Comparable scale and service scope, with overlap on custom API synthesis use cases.
• Curia (formerly AMRI): Contract development and manufacturing organization with API, drug product, and analytical services across small molecules. Comparable integrated service model for pharma and biotech customers.
• Cambrex: Pure-play small molecule API and finished dosage CDMO offering process development, analytical and manufacturing services from US and European sites. Directly comparable small-molecule CDMO platform and customer profile to Benuvia.

Broad incumbents

• Lonza: One of the world's largest CDMOs spanning small molecules, biologics and cell therapies. Overlaps with Benuvia on small molecule API and drug product services but at fundamentally larger scale and geography.
• Siegfried Holding: Swiss-listed CDMO with API and drug product manufacturing for small molecules. Comparable in service offering to Benuvia but at larger enterprise scale and broader global footprint.
• Patheon (Thermo Fisher Scientific): Global large-scale CDMO offering comprehensive drug substance, drug product and commercial manufacturing across modalities. Overlaps with Benuvia's API plus formulation services but operates at much greater scale and breadth.
• Catalent: Major global CDMO providing development and manufacturing for oral, injectable and specialty dosage forms. Competes for the same biotech and pharma customers, though focuses on broader formulation categories including biologics and softgel.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/benuvia-operations-llc

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Benuvia Manufacturing