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Hard Capsules CDMO Companies
Hard Capsules Contract Manufacturing Services

Your Trusted Partners for Hard Capsules Contract Manufacturing and Development

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Adare Pharma | EU
Italy

Adare Pharma | EU

Adare Pharma Solutions

Global CDMO offering turnkey product development through commercial manufacturing expertise, focused on oral dosage forms.

SERVICES: Development services, Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services

MARKETS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE), TGA (Australia)

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Halal Research Council, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, French Service-Public (CIR), NMPA (China GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)

USE: Human, Veterinary

BATCH SIZE: Large, Small, Medium

THERAPEUTIC AREAS OF EXPERTISE (ATC): (N) Nervous system, (J) Antiinfectives for systemic use, (V01) Allergens, (R) Respiratory system, (M) Musculoskeletal system, (C) Cardiovascular system, (A) Digestive tract and metabolism

OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day)

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, PARTICLE ENGINEERING, SERVICES

REGION: Europe

Adare Pharma | US
United States

Adare Pharma | US

Adare Pharma Solutions

Adare Pharma es un CDMO global con instalaciones en EE.UU. y la UE, que ofrece desarrollo de productos llave en mano mediante experiencia en fabricación comerci

SERVICES: Development services, Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services

MARKETS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE), TGA (Australia)

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Halal Research Council, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, French Service-Public (CIR), NMPA (China GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)

USE: Human, Veterinary

BATCH SIZE: Large, Small, Medium

OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day)

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, PARTICLE ENGINEERING, SERVICES

THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (A) Digestive tract and metabolism

REGION: North America

FAES FARMA | DERIO facility
Spain

FAES FARMA | DERIO facility

FAES FARMA

Developer and manufacturer of human medicinal products.

SERVICES: Development services, Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services

MARKETS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), MFDS (South Korea), EDE (UAE), TGA (Australia)

COMPLIANCE: DIGEMID, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), ECOVADIS, TGA (Australia GMP), INVIMA, ISP (Chile BPM), French Service-Public (CIR), NMPA (China GMP), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)

USE: Human

BATCH SIZE: Large, Small, Medium

THERAPEUTIC AREAS OF EXPERTISE (ATC): (N) Nervous system, (J) Antiinfectives for systemic use, (D) Dermatologicals, (R) Respiratory system, (M) Musculoskeletal system, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (A) Digestive tract and metabolism

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)

REGION: Europe

Cenexi
France

Cenexi

Cenexi

GMP plant on a four-hectare site is located 9 km east of Paris. It is a center of excellence for injectable ampoules.

SERVICES: Development services, Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services

MARKETS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), EDE (UAE), TGA (Australia)

COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), NMPA (China GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)

USE: Human, Veterinary

BATCH SIZE: Large, Small, Medium

CONTROLLED SUBSTANCES: Lowest potential for abuse, Lower potential for abuse, High potential for abuse & no medical use, High potential for abuse & medical use, Low potential for abuse

THERAPEUTIC AREAS OF EXPERTISE (ATC): (N) Nervous system, (J) Antiinfectives for systemic use, (D) Dermatologicals, (P) Antiparasitic products, insecticides and repellents, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (C) Cardiovascular system, (A) Digestive tract and metabolism

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)

REGION: Europe

Laboratorio REIG JOFRE, SA (TOLEDO PLANT)
Spain

Laboratorio REIG JOFRE, SA (TOLEDO PLANT)

LABORATORIO REIG JOFRE SA

Betalactam antibiotics (FDF) development and manufacturing state-of-the-art facilities.

MARKETS: EMA (EU), ANVISA (Brazil), ISP (Chile), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), INVIMA (Colombia), SFDA (Saudi Arabia), TGA (Australia)

REGION: APAC, MENA, LATAM, Europe, North America

COMPLIANCE: DIGEMID, ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), ECOVADIS, TGA (Australia GMP), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ISP (Chile BPM), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP)

BATCH SIZE: Large, Medium

USE: Human, Veterinary

BSL (Biological Safety Level): 1

SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

THERAPEUTIC AREAS OF EXPERTISE (ATC): (J) Antiinfectives for systemic use

CONTROLLED SUBSTANCES: Lowest potential for abuse

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

ALPHAVET Zrt.- Bábolna Manufacturing Plant
Hungary

ALPHAVET Zrt.- Bábolna Manufacturing Plant

Alphavet Zrt.

The plant is EU GMP certified and produces veterinary medicinal products for 18 EU Member States and 7 other European coutries outside the EU.

MARKETS: EMA (EU)

REGION: Europe

COMPLIANCE: ISO, EMA (EU GMP)

BATCH SIZE: Large, Medium

CATEGORY / PRODUCT: NUTRACEUTICALS, FDF / DRUG PRODUCTS

USE: Veterinary

SERVICES: Manufacturing services, Analytical / QC services, Regulatory services, Packaging

Sidefarma
Portugal

Sidefarma

Sidefarma SA

CMO specialized in the manufacture of small and medium size batches for pharmaceutical companies across the world in regulated markets.

CONTROLLED SUBSTANCES: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

MARKETS: EMA (EU), PMDA (Japan), Health Canada (Canada), DIGEMID (Peru), MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities, EDE (UAE), TGA (Australia)

REGION: Europe

COMPLIANCE: ISO, UAE Ministry of Health & Prevention, EMA (EU GMP)

USE: Human

SERVICES: Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging

BATCH SIZE: Small, Medium

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

Aenova Group - Location Tittmoning, Germany
Germany

Aenova Group - Location Tittmoning, Germany

Aenova

Competence Center conventional solids high volume plant.

MARKETS: EMA (EU), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, TGA (Australia)

REGION: Europe

COMPLIANCE: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TGA (Australia GMP), EMA (EU GMP), Health Canada (Canada GMP)

BATCH SIZE: Large, Medium

CATEGORY / PRODUCT: NUTRACEUTICALS, FDF / DRUG PRODUCTS

USE: Human, Veterinary

SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

Aenova Group - Location Sisseln, Switzerland
Switzerland

Aenova Group - Location Sisseln, Switzerland

Aenova

Competence Center complex conventional solids.

REGION: Europe

MARKETS: FDA (USA), ANVISA (Brazil), Russian Health Authorities, MFDS (South Korea), Turkish Health Authorities

COMPLIANCE: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), World Health Organization (GMP / HACCP), MFDS/KFDA (Republic of Korea GMP)

BATCH SIZE: Large, Small, Medium

CATEGORY / PRODUCT: NUTRACEUTICALS, FDF / DRUG PRODUCTS

USE: Human

SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

Aenova Group - Location Regensburg, Germany
Germany

Aenova Group - Location Regensburg, Germany

Aenova

Competence Center high potent solids (oncology) conventional solids - specialty semisolids & liquids.

OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

MARKETS: EMA (EU), PMDA (Japan), FDA (USA), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities

REGION: Europe

COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)

BATCH SIZE: Large, Small, Medium

CATEGORY / PRODUCT: COSMETICS, NUTRACEUTICALS, FDF / DRUG PRODUCTS, PARTICLE ENGINEERING

USE: Human, Veterinary

SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

Aenova Group - Location Münster, Germany
Germany

Aenova Group - Location Münster, Germany

Aenova

Competence Center low-dosed high potent solids (hormones, hormone-like), low-dosed capsules.

OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

MARKETS: EMA (EU), FDA (USA), ANVISA (Brazil), Russian Health Authorities, MFDS (South Korea), Turkish Health Authorities

REGION: Europe

COMPLIANCE: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)

BATCH SIZE: Large, Small, Medium

USE: Human, Veterinary

SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

THERAPEUTIC AREAS OF EXPERTISE (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

Aenova Group - Location Marburg, Germany
Germany

Aenova Group - Location Marburg, Germany

Aenova

Competence Center complex conventional solids and narcotics.

CONTROLLED SUBSTANCES: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, High potential for abuse & no medical use, Lower potential for abuse

MARKETS: EMA (EU), FDA (USA), ANVISA (Brazil), Russian Health Authorities

REGION: Europe

COMPLIANCE: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), EMA (EU GMP)

BATCH SIZE: Large, Small, Medium

CATEGORY / PRODUCT: NUTRACEUTICALS, FDF / DRUG PRODUCTS

USE: Human

SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

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Hard capsules remain a popular oral dosage form due to their versatility, ease of swallowing, and compatibility with a wide range of formulations. From standard gelatin capsules to HPMC and delayed-release systems, specialized hard capsules CDMO companies help pharmaceutical brands develop and produce high-quality products efficiently and compliantly.

By partnering with providers of hard capsules contract manufacturing, you gain access to flexible capsule technologies, GMP facilities, and proven expertise in handling APIs from early development through commercial launch.

How to Choose Hard Capsules CDMO Companies

Choosing the right hard capsules CDMO involves assessing capabilities across formulation, encapsulation, and regulatory compliance. Key factors to consider:

The most commoncapsule types offered: Gelatin, HPMC (vegetarian), acid-resistant, enteric-coated, and various sizes.

Formulation compatibility: Powders, pellets, granules, mini-tablets, and liquids.

Controlled-release technologies: Multi-particulate filling, modified-release beads, and matrix systems.

Analytical testing: Content uniformity, disintegration, dissolution, and moisture analysis.

Flexibility in batch size: Suitable for clinical trials or commercial-scale production.

Experience with high-potency or moisture-sensitive APIs.

A capable CDMO ensures your product is delivered in a capsule that meets performance, regulatory, and patient expectations.

Key Services Offered by Hard Capsules Contract Manufacturers

Comprehensive hard capsules contract manufacturing services typically include:

Formulation development: Powders, pellets, or combination fills.

Capsule selection and sourcing: Material, size, and release profile.

Filling and sealing: Hard gelatin and HPMC capsules.

Modified-release solutions: Enteric-coated pellets or timed-release beads.

Encapsulation of sensitive or potent compounds.

Stability studies and ICH-compliant storage.

Primary and secondary packaging.

Regulatory support: Global filings (IND, ANDA, EU dossiers).

These services enable pharma companies to bring capsule-based products to market efficiently.

Advantages of Partnering with Hard Capsules CDMO Companies

Working with trusted hard capsules CDMO companies provides key benefits:

Broad formulation compatibility: Suitable for solids and multiparticulates.

Improved speed to market: Integrated development and filling processes.

High flexibility: Capsule type and dosage form customization.

Regulatory confidence: Validated processes and inspection-ready facilities.

Support for lifecycle management: New strengths, release profiles, or combinations.

Whether for branded drugs, generics, or nutraceuticals, the right CDMO brings flexibility and scale.

Hard Capsules CDMO Companies

Some of the leading hard capsules CDMO companies include:

Lannett: Oral Solid Dose (OSD) and liquids. [See CDMO profile]

Pharmaloop (a Salvat company): Fully integrated solutions including BFS, sterile and non-sterile multi-dose, sachets, hard capsules, and tablets. [See CDMO profile]

Reig Jofre: FDF development and manufacturing in state-of-the-art facilities. [See CDMO profile]

Cenexi: Injectables manufacturing. [See CDMO profile]

FAES FARMA: Manufacturer of medicinal products including hard capsules. [See CDMO profile]

Cambrex: Early development of small molecule products in integrated DS/DP facilities. [See CDMO profile]

Skyepharma: Fully integrated FDF CDMO with expertise in oral technologies. [See CDMO profile]

Huiyu Pharmaceuticals Co., Ltd: Developer of complex forms including implants, OSD and sterile forms. [See CDMO profile]

Aenova Group: Competence center for solids and clinical services. [See CDMO profile]

I+Med: Developer of controlled-release drug products. [See CDMO profile]

Adragos Pharma: Manufacturing of oral liquids, semisolids, and OSD. [See CDMO profile]

Glatt Pharmaceutical Services GmbH Co. & KG: End-to-end CDMO for complex OSD. [See CDMO profile]

Darnytsia Kyiv: Manufacturer of oral liquids, semisolids, and OSD. [See CDMO profile]

Adare Pharma: Turnkey development and manufacturing for oral dosage forms. [See CDMO profile]

Sidefarma: Specialist in small- and medium-batch liquids, semisolids and OSD. [See CDMO profile]

Basic Pharma Manufacturing: Analytical testing, regulatory support, and OSD/sterile manufacturing. [See CDMO profile]

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Let MAI CDMO Help You Find the Right Hard Capsules CDMO Partner

At MAI CDMO, we connect pharma and biotech companies with leading hard capsules CDMO companies offering tailored hard capsules contract manufacturing solutions. Whether you’re working on a simple IR capsule or a complex multiparticulate system, we help you find the best-fit partner for your scale, speed, and quality goals.

Looking for flexible capsule manufacturing support? Contact us today and discover your best-fit CDMO.