DEA Scheduled Substance CDMOs

Benuvia Operations, LLC

United States

Benuvia Operations, LLC is a US-based specialized CDMO and API supplier focused on controlled substances. They pioneer work with cannabinoids, psychedelics, and traditional pharmaceuticals, offering a unified services platform from IND-enabling through commercial manufacturing. They hold DEA registrations and are FDA-registered for API manufacture, analysis, labeling, manufacturing, and packing. Their SYNDROS (Dronabinol) CII product demonstrates their controlled substance expertise.

Bora Pharmaceutical

Canada

Bora Pharmaceuticals is a global CDMO headquartered in Canada with manufacturing facilities across North America and Asia. The company offers comprehensive contract development and manufacturing services for oral solid dosages, sterile injectables, topicals, and liquids, serving both clinical and commercial supply needs with FDA and EMA approved facilities.

Cambrex

Canada

Halo Pharmaceuticals, acquired by Cambrex in 2018 for $425 million and later sold to SK Capital Partners in 2023, is a drug product CDMO specializing in oral solids, liquids, creams, sterile and non-sterile ointments, complex formulations, pediatric indications, and controlled substances. The company operates 430,000 square feet of GMP-compliant manufacturing space across Whippany, New Jersey and Montreal, Quebec, serving over 85 clients.

Hikma Pharmaceuticals

Algeria

Hikma Pharmaceuticals is a global pharmaceutical company with 29 manufacturing plants across the US, Europe, and MENA, producing injectable, oral, and respiratory medicines. The company offers CMO services and has announced a $1 billion investment by 2030 to expand US manufacturing and R&D capabilities. Hikma has 76 FDA-approved products, produces 500 million injectable units annually, and has maintained zero critical FDA observations in 20+ years.

Jiangsu Nhwa Pharmaceutical Co., Ltd.

China

Jiangsu Nhwa Pharmaceutical Co., Ltd. is a leading Chinese pharmaceutical company specializing in CNS (Central Nervous System) drugs, listed on Shenzhen Stock Exchange (002262.SZ) since 2008. Founded in 1978, the company is designated as a national production unit for narcotic and psychotropic drugs. Nhwa operates over 10 automated production lines for tablets, capsules, liquid injectables, and powder injectables, covering over 800 acres. The company serves as a major global CNS drug production and R&D base.

Senores Group

India

Senores Group (Senores Pharmaceuticals Limited) is an India-based CDMO specializing in complex generic oral solid dosage forms and API manufacturing. The company operates 5 manufacturing facilities including 2 USFDA-approved formulation plants (Atlanta, USA and Gujarat, India) and 2 API/intermediates plants. Senores serves 300+ customers in 49 countries, with particular strength in controlled substances (C2-C5), extended-release, and orally disintegrating tablet formulations.

Sever Pharma Solutions

France

Sever Pharma Solutions is a specialized CDMO focused on high-potent and cytotoxic drug products (up to OEB6), polymer-based controlled-release delivery systems (implants, vaginal rings), hot melt extrusion for bioavailability enhancement, and prefilled syringe/autoinjector aseptic fill-finish. With sites in Malmö (Sweden) and Putnam (Connecticut, USA), they offer end-to-end services from formulation development through commercial manufacturing.

Alcami

United States

Alcami is a US-based CDMO with 45+ years of experience providing integrated drug product manufacturing, laboratory services, and cGMP pharmaceutical storage. The company specializes in sterile fill-finish manufacturing (liquid and lyophilized injectables, prefilled syringes) and oral solid dose, with DEA licensing for controlled substances and EU/Annex 1 compliance.

Altasciences

Canada

Altasciences is a North American CRO/CDMO offering integrated early-phase drug development services. The company provides preclinical safety testing, clinical pharmacology (Phase I-II), bioanalysis, and manufacturing/analytical services including formulation development, drug product manufacturing (tablets, capsules, suspensions, creams, terminally sterilized injectables), and ICH stability testing, with DEA licensing for Schedule I-V substances.

Apace Packaging LLC

United States

Apace Packaging is a U.S.-based FDA-registered contract pharmaceutical packaging and manufacturing company. They specialize in pharmaceutical packaging (blistering, bottling, tube filling, sachet packaging, clinical trial packaging) and also perform liquid and semi-solid manufacturing (blending, tube filling). They are DEA-licensed for Schedule II-V controlled substances.

Aphena Pharma Solutions

United States

Aphena Pharma Solutions is a U.S.-based contract pharmaceutical manufacturing and packaging company operating from two FDA-registered locations. They specialize in liquid dose manufacturing, oral solid dose packaging, blister packaging, bottling, tube filling, injectable assembly, and clinical packaging. They are DEA-licensed for Schedule II-V controlled substances and ISO 13485 certified for medical devices.

Avara Pharmaceutical Services

United States

Avara Pharmaceutical Services is an international contract manufacturing organization (CMO) headquartered in Norman, Oklahoma, specializing in commercial-scale drug product manufacturing. Their core capabilities include oral solid dose (including potent compounds and targeted release formulations) with capacity of 1.5 billion doses per year, liquid and lyophilized sterile injectable fill-finish with terminal sterilization and high containment, and integrated packaging with serialization, automated inspection, and specialty packaging. Avara operates former branded pharmaceutical facilities in the US (Norman, Oklahoma and Arecibo, Puerto Rico) and Italy (Liscate), serving 40+ countries. Facilities hold approvals from FDA, DEA, ANVISA, MPA (Sweden), and other international agencies.

Coating Place Inc

United States

Coating Place Inc is a Wisconsin-based pharmaceutical CDMO founded in 1976, specializing in Wurster fluid bed coating technology for oral solid dosage forms. The company operates FDA- and EMA-approved GMP facilities in Verona and Sauk City, Wisconsin, with 24 proprietary Wurster fluid bed coaters handling batches from 0.010 kg to 800 kg, and is DEA-licensed for Schedule I-V controlled substances. The company celebrated its 50th anniversary in 2026.

Confab Laboratories

Canada

Confab Laboratories is a well-established CDMO located on Montreal's South Shore, Canada, specializing in non-sterile pharmaceutical manufacturing of liquid, solid, and semi-solid dosage forms. The company provides end-to-end services including formulation development, technology transfer, analytical services, and commercial manufacturing for prescription, OTC, generic, controlled drugs, and veterinary products. Confab operates a 100,200 square-foot GMP facility with 32 manufacturing suites and 17 packaging suites, approved by both the FDA and Health Canada.

CorePharma LLC

United States

CorePharma LLC, founded in 1998 and headquartered in Middlesex, NJ, is a CDMO specializing in oral solid dosage forms including IR and ER tablets and capsules. The company offers end-to-end services from product development and contract manufacturing to packaging and analytical testing, with cGMP-compliant FDA & DEA registered facilities producing over 2 billion units annually.

Custom Pharma Services

United Kingdom

Custom Pharma Services is a UK-based CDMO founded in 1979 in Brighton, specializing in oral solid dose manufacturing and packaging for clinical and commercial use. The company is MHRA-approved and FDA-inspected, with capacity exceeding 1.5 billion tablets and 250 million capsules annually. Custom Pharma handles controlled drugs, hormonal products, and has launched Centrix Pharma Solutions for early-stage development.

Dalton Pharma Services

Canada

Dalton Pharma Services is a Canadian CDMO and subsidiary of Seikagaku Corporation Japan, providing integrated drug discovery, development, and manufacturing services. The company is FDA-inspected and Health Canada-approved with over 35 years of experience, specializing in custom chemical synthesis, cGMP API manufacturing, sterile vial filling, and formulation development including liposomal formulations. Dalton recently announced major expansion of its commercial sterile manufacturing capacity.

Iberfar – Industria Farmaceutica, S.A.

Portugal

Iberfar, Industria Farmaceutica, S.A. is a privately owned Portuguese pharmaceutical contract manufacturer founded in 1924. The company specializes in contract manufacturing of solid forms and non-sterile liquid products, including controlled drugs, at its EU cGMP-certified facility near Lisbon.

NextPharma

Finland

NextPharma is a European pharmaceutical CDMO headquartered in Finland with 10 manufacturing sites across Europe. The company provides pharmaceutical development, clinical trial supply, commercial manufacturing, packaging, and analytical services across a wide range of dosage forms including solids, semi-solids, liquids, softgel capsules, ophthalmics, modified release products, and specialist areas such as hormones, cephalosporins, penicillins, and narcotics.

Phyton Biotech

Canada

Phyton Biotech is the world's largest provider of Plant Cell Fermentation (PCF) technology, producing paclitaxel and docetaxel (key oncology APIs). Offers comprehensive contract product/process development and commercial manufacturing services for high-value active ingredients from fermentation. Operates GMP commercial manufacturing facilities in Germany and Canada, both US FDA and Health Canada approved. Recently received Controlled Substances Dealers License from Health Canada.

Praxis Packaging Solutions

United States

Praxis Packaging Solutions is a U.S.-based contract packaging company in Grand Rapids, Michigan, providing primary and secondary packaging services for pharmaceutical, OTC, and healthcare products. Their capabilities include solid dose packaging (bottling, blister packaging), liquid/cream/paste filling for tubes, bottles, jars, and flexible packaging, and secondary packaging (labeling, cartoning, bundling, kitting). They operate FDA-registered, DEA-licensed (Schedule III-V), and cGMP-compliant facilities. FDA-registered with 2 FEI numbers with 4 inspections (3 NAI, 1 VAI). While primarily a packager, they perform contract manufacturing for finished dosage forms.

Purisys

United States

Purisys is a US-based CDMO specializing in custom Active Pharmaceutical Ingredients (APIs) and chemical synthesis projects, with over 40 years of commercial pharmaceutical production experience. The company is a global leader in pharmaceutical-grade cannabinoids and psychedelic compounds, with DEA-secure manufacturing capabilities. Purisys also offers reference standard synthesis and qualification with over 300 commercial standards. The company was recently acquired by Siegfried alongside Noramco.

R L Fine Chem Pvt Ltd

India

R L Fine Chem Pvt Ltd (RLFC) is an Indian API manufacturer established in 1984, pioneering the development and production of psychotropic and CNS substances in India. The company exports APIs to over 80 countries across the globe, with a leadership position in multiple therapeutic areas including anti-depressants, anti-psychotics, anxiolytics, anti-convulsants, anti-histamines, anti-malarials, and hypnotics. RLFC operates multiple GMP manufacturing plants with DSIR-approved R&D.

Siegfried Group

China

Siegfried Group is a leading global CDMO with 150+ years of pharmaceutical and chemical heritage, operating 13 production sites across Switzerland, Germany, Spain, France, Malta, the USA, and China. The company provides integrated services from early-phase API development through commercial-scale drug substance and drug product manufacturing, including exclusive synthesis, generic APIs, controlled substances, HPAPI handling, sterile formulations, and viral vector manufacturing through subsidiary DINAMIQS. In January 2026, Siegfried announced acquisition of additional US-based small molecule drug substance capacity.

Sterling Pharma Solutions

Ireland

Sterling Pharma Solutions is a global CDMO with over 50 years of experience providing API development and manufacturing services to pharmaceutical and biotech companies. The company specializes in high potency APIs, hazardous chemistry, controlled substances, peptides, flow chemistry, biocatalysis, and ADC bioconjugation across six facilities in the UK, Ireland, and US.

Tedor Pharma Inc

United States

Tedor Pharma is a US-based CDMO with 20+ years of experience specializing in solid oral dosage forms. Located in Cumberland, Rhode Island, they provide end-to-end outsourcing from IND/NDA/ANDA through commercial manufacture. Services include formulation development, clinical trial manufacturing (including placebo), commercial GMP manufacturing at various scales, analytical services (characterization, testing, development, QA), and clinical supply chain management. FDA-registered and inspected (5 inspections, all VAI), DEA-licensed for controlled substances Schedules II-V. They have 2 FDA-approved products (tablets, oral route). The company announced a recapitalization and new management.

Titan Laboratories Pvt Ltd

India

Titan Laboratories Pvt Ltd is an integrated Indian pharmaceutical company and the first Indian pellet company to receive EU-GMP Written Confirmation. Established in 2004, it manufactures and exports pharmaceuticals and APIs across 47 countries, with specialization in pellets, granules, tablets, capsules, and creams/ointments. The company holds EU-GMP, TGA, ANVISA, WHO-GMP, MFDS, and other international approvals.

TITAN PHARMAPLUS PVT. LTD

India

Titan Pharmaplus Pvt. Ltd. is an Indian pharmaceutical API manufacturer and CDMO committed to innovation, quality, and sustainability. The company produces a wide range of small molecule APIs including Apixaban, Dapagliflozin, Acyclovir, Dexlansoprazole, and controlled substances, with state-of-the-art cGMP facilities and advanced chemical synthesis capabilities including high-pressure hydrogenation, Grignard reactions, and asymmetric oxidation.

Valpharma Group

San Marino

Valpharma Group is a pharmaceutical and nutraceutical CDMO based in San Marino with 40+ years of experience. The group consists of Valpharma San Marino S.p.A. and Valpharma International S.p.A. (two CDMO pharmaceutical companies) plus Erba Vita Group S.p.A. (nutraceuticals). They specialize in modified-release products in capsules and tablets, including narcotic and psychotropic substances. Services include contract manufacturing, tech transfer, regulatory and e-CTD management, pharmaceutical development, stability studies, and IMP (investigational medicinal product) batch production. They operate three production plants and are routinely audited by Italian Health Authorities for GMP compliance. Products sold in 70+ countries.

Alcaliber

Spain

Alcaliber is a Spanish CDMO specializing in the cultivation, extraction, and manufacture of narcotic raw materials (NRM) and active pharmaceutical ingredients (APIs) from poppy extracts. The company offers full supply chain control from agricultural cultivation to finished API production, with over 50 years of experience and CDMO/CMO services including extraction, synthesis, milling, and micronization.

Australian ALKALOIDS Trading PTY LTD

Australia

Australian Alkaloids Trading (AAT) is a 100% Australian-owned API manufacturer specializing in naturally extracted alkaloid APIs and semi-synthetic compounds derived from Duboisia plants. AAT is a joint venture of Phytex and Australian Alkaloids, with 60+ years of combined experience. The company controls its entire supply chain domestically in Australia, from Duboisia plantations through extraction, purification, and final API release. Products include scopolamine (hyoscine) derivatives, atropine derivatives, and methscopolamine bromide. AAT's facilities are cGMP licensed with the TGA, USFDA inspected, and supply USP and PMRJ reference standards. They have a history of zero product recalls.

SCI Pharmtech Inc. is a Taiwan-based API manufacturer originally founded by Switzerland-based Siegfried Ltd. in 1987, now publicly listed on the Taiwan Stock Exchange. The company specializes in APIs, advanced intermediates, and custom products with US FDA and EDQM inspected, ISO-certified facilities. SCI Pharmtech focuses on rapid development and cost-effective production.