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Granules CDMO Companies
Granules Contract Manufacturing Services

Your Trusted Partners for Granules Contract Manufacturing and Development

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Avara Pharmaceutical Services | Arecibo Site
United States

Avara Pharmaceutical Services | Arecibo Site

AVARA

Commercial-scale oral solid dosage (OSD) manufacturing facility with strong expertise in controlled substances (DEA II V).

BATCH SIZE: Medium, Large

THERAPEUTIC AREAS OF EXPERTISE (ATC): (R) Respiratory system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (S) Sensory organs, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (N) Nervous system, (B) Blood and blood forming organs

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, PARTICLE ENGINEERING, CHEMICAL-SYNTHETIC

COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), FDA (cGMP), Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP), ICH

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

MARKETS: ANVISA (Brazil), PMDA (Japan), FDA (USA), Russian Health Authorities, EMA (EU), MFDS (South Korea), TGA (Australia), Health Canada (Canada)

USE: Human

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

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

REGION: North America

Avara Pharmaceutical Services | Norman Site
United States

Avara Pharmaceutical Services | Norman Site

AVARA

Contract manufacturing facility specialized in Oral Solid Dosage (OSD) for clinical and commercial supply.

BATCH SIZE: Small, Medium, Large

THERAPEUTIC AREAS OF EXPERTISE (ATC): (R) Respiratory system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (S) Sensory organs, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (N) Nervous system, (B) Blood and blood forming organs

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, PARTICLE ENGINEERING, CHEMICAL-SYNTHETIC

COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MHRA (UK GMP), TGA (Australia GMP), FDA (cGMP), Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP), ICH

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

MARKETS: ANVISA (Brazil), PMDA (Japan), FDA (USA), Russian Health Authorities, EMA (EU), MFDS (South Korea), TGA (Australia), Health Canada (Canada), MHRA (UK)

USE: Human

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

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

REGION: North America

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.

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

BATCH SIZE: Small, Medium

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

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

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

REGION: Europe

USE: Human

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

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

FAES FARMA | DERIO facility
Spain

FAES FARMA | DERIO facility

FAES FARMA

Developer and manufacturer of human medicinal products.

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

BATCH SIZE: Small, Medium, Large

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

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

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

REGION: Europe

USE: Human

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

OEB (Occupational Exposure Banding): 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.

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

BATCH SIZE: Small, Medium, Large

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, NUTRACEUTICALS

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

REGION: Europe

USE: Human

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

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

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

BATCH SIZE: Small, Medium, Large

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

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

REGION: Europe

USE: Human, Veterinary

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

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

Aenova Group - Location Marburg, Germany
Germany

Aenova Group - Location Marburg, Germany

Aenova

Competence Center complex conventional solids and narcotics.

BATCH SIZE: Small, Medium, Large

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, NUTRACEUTICALS

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

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

REGION: Europe

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

USE: Human

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

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

Aenova Group - Location Killorglin, Ireland
Ireland

Aenova Group - Location Killorglin, Ireland

Aenova

Competence Center for spray drying and modified release pellets.

BATCH SIZE: Small, Medium, Large

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

COMPLIANCE: EMA (EU GMP), PMDA/MHLW (Japan GMP), SFDA (Saudi Food & Drug Authority), ISO, MFDS/KFDA (Republic of Korea GMP)

REGION: Europe

USE: Human, Veterinary

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

MARKETS: PMDA (Japan), EMA (EU), MFDS (South Korea), SFDA (Saudi Arabia)

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

Aenova Group - Location Gronau, Germany
Germany

Aenova Group - Location Gronau, Germany

Aenova

Competence center for conventional solids and clinical services.

BATCH SIZE: Small, Medium, Large

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), FDA (cGMP)

MARKETS: EDE (UAE), ANVISA (Brazil), PMDA (Japan), FDA (USA), Russian Health Authorities, EMA (EU)

REGION: Europe

USE: Human, Veterinary

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

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

Adragos Pharma |  Athens
Greece

Adragos Pharma | Athens

Adragos Pharma

Specializes in the development of Value Added Medicines and has been recently upgraded with HPAPI capabilities.

MARKETS: ANMAT (Argentina), EDE (UAE), ANVISA (Brazil), PMDA (Japan), FDA (USA), CDSCO (India), EMA (EU), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), MHRA (UK)

BATCH SIZE: Small, Medium, Large

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES

COMPLIANCE: EMA (EU GMP), PMDA/MHLW (Japan GMP), UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), FDA (cGMP), NSF, NMPA (China GMP), ISO, MFDS/KFDA (Republic of Korea GMP)

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

REGION: Europe

USE: Human

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

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

Glatt Pharmaceutical Services GmbH Co. & KG
Germany

Glatt Pharmaceutical Services GmbH Co. & KG

Glatt Pharmaceutical Services GmbH Co. & KG

Your cGMP-compliant CDMO for end-to-end services in the complex oral solids dosage forms field, based in Binzen Germany.

BATCH SIZE: Small, Medium, Large

THERAPEUTIC AREAS OF EXPERTISE (ATC): (R) Respiratory system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (S) Sensory organs, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (N) Nervous system, (B) Blood and blood forming organs, (V06) Nutrients

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

COMPLIANCE: EMA (EU GMP), FDA (cGMP)

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

REGION: Europe

USE: Human, Veterinary

SERVICES: Analytical / QC services, Manufacturing services, Development services

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

MARKETS: FDA (USA), EMA (EU)

BSL (Biological Safety Level): 1

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

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

BATCH SIZE: Small, Medium, Large

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

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

USE: Human, Veterinary

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

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

REGION: North America

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

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Granules are a flexible oral dosage form offering advantages in taste-masking, stability, and modified release — making them ideal for pediatric, geriatric, and specialty treatments. Whether you´re developing sachets, effervescent blends, or multiparticulate systems, specialized granules CDMO companies provide the expertise to take your product from formulation to full-scale manufacturing.

By outsourcing to experts in granules contract manufacturing, pharmaceutical and nutraceutical companies ensure precise granulation, dosing uniformity, and regulatory compliance across global markets.

How to Choose Granules CDMO Companies

When evaluating granules CDMO companies, key considerations include:

  • Formulation experience: Effervescent, sustained-release, taste-masked, or fast-dispersing granules
  • Granulation technologies: Wet granulation, dry granulation, roller compaction, and fluid bed processing
  • Equipment flexibility to handle various batch sizes and material sensitivities
  • Moisture and heat-sensitive API capabilities
  • Analytical expertise: Uniformity, dissolution, and particle size distribution
  • Packaging integration: Sachets, stick packs, jars, or bulk formats
  • GMP compliance and global regulatory support

Choosing a granulation expert ensures process robustness and consistent performance.

Key Services Offered by Granules Contract Manufacturers

Trusted granules contract manufacturing providers offer:

  • Pre-formulation and excipient selection for desired release profile and taste
  • Wet and dry granulation process development
  • Effervescent granule formulation and stability testing
  • Multiparticulate systems for modified or extended-release applications
  • Blending and flavor masking for palatability and patient adherence
  • Sachet and stick-pack filling under GMP
  • Analytical testing for content uniformity, dissolution, and moisture control
  • Regulatory documentation and CMC support

These services are ideal for products targeting flexible dosing, improved compliance, and formulation complexity.

Advantages of Partnering with Granules CDMO Companies

Collaborating with top-tier granules CDMO companies offers key benefits:

  • Customizable release profiles for therapeutic differentiation
  • Pediatric and geriatric-friendly formats with easy administration
  • Improved API stability in dry, granulated form
  • Efficient scalability from development to large-scale production
  • Cost-effective packaging options for single-dose or multi-dose regimens

Granules offer versatility, and the right CDMO ensures your product leverages that to its full potential.

Granules CDMO Companies

Some of the most trusted granules CDMO companies include:

  • Lannett: Oral Solid Dose (OSD) and Liquids. [See CDMO profile]
  • Pharmaloop (a Salvat company): Fully integrated CDMO solutions for Blow-Fill-Seal (BFS), sterile multidose, non-sterile multi-dose, sachets, hard capsules, and tablets. [See CDMO profile]
  • Cenexi: Injectables manufacturing. [See CDMO profile]
  • Aenova: Competence Center complex conventional solids, including granules. [See CDMO profile]
  • Skyepharma: Fully integrated FDF CDMO, key player in oral technologies serving global pharmaceutical, biotech and consumer health industries. [See CDMO profile]
  • Adare Pharma: Turnkey development and commercial manufacturing for oral dosage forms across Pharma, Animal Health and OTC markets. [See CDMO profile]
  • Sichuan Huiyu Pharmaceuticals Co., Ltd.: Development and production of complex and high-value dosage forms including implants, oral solids / OSD and sterile formulations. [See CDMO profile]
  • I+Med: Developer and manufacturer of new drug products using controlled-release technologies, including implants, oral liquids and semisolids, and oral solids. [See CDMO profile]
  • Adragos Pharma: Specializes in Value Added Medicines and manufacturing of oral liquids and semisolids, oral solids / OSD. [See CDMO profile]
  • Glatt Pharmaceutical Services GmbH Co. & KG: cGMP-compliant CDMO delivering end-to-end services for complex oral solid dosage forms. [See CDMO profile]
  • Sidefarma: Specialized in small- and medium-scale manufacturing for pharmaceutical companies, including oral liquids and semisolids, oral solids / OSD. [See CDMO profile]
  • FAES FARMA | DERIO facility: Developer and manufacturer of human medicinal products, offering comprehensive pharmaceutical development and manufacturing capabilities. [See CDMO profile]

Related Information

Let MAI CDMO Help You Find the Right Granules CDMO Partner

At MAI CDMO, we help you connect with leading granules CDMO companies that offer full-service granules contract manufacturing — from development and scale-up to packaging and regulatory support. Whether you need effervescent granules, modified-release formats, or pediatric sachets, we’ll match you with the right partner for success.

Looking for granule formulation expertise you can trust? Contact us today to get started.