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Large Batch Size CDMO Companies
Large Batch Size Contract Manufacturing Services

Your Trusted Partners for Large Batch Size Contract Manufacturing Services and High-Volume Drug Production

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SENN Chemicals | GMP Production | Dielsdorf, Switzerland
Switzerland

SENN Chemicals | GMP Production | Dielsdorf, Switzerland

Senn Chemicals

Swiss cGMP production site for LPPS, SPPS and hybrid peptide manufacturing from pilot to early commercial scale.

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

REGION: Europe

BATCH SIZE: Large, Medium

CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC, PARTICLE ENGINEERING

SENN India | Non-GMP Plant | Hyderabad, India
India

SENN India | Non-GMP Plant | Hyderabad, India

Senn Chemicals

Large scale non GMP manufacturing site for peptide intermediates, organic synthesis, LPPS operations and scale up production.

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

REGION: APAC

BATCH SIZE: Large, Small, Medium

CATEGORY / PRODUCT: COSMETICS, CHEMICAL-SYNTHETIC, SERVICES, PARTICLE ENGINEERING

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

Laboratorios Grifols | Barcelona Plant
Spain

Laboratorios Grifols | Barcelona Plant

Grifols International

Sterile manufacturing solutions (small molecules) in flexible bags and vials.

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

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

REGION: Europe

COMPLIANCE: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), ECOVADIS, TGA (Australia GMP), INVIMA, ISP (Chile BPM), 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)

BATCH SIZE: Large, Small, Medium

USE: Human, Veterinary

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

CONTROLLED SUBSTANCES: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

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

Laboratorio REIG JOFRE, SA (BARCELONA PLANT)
Spain

Laboratorio REIG JOFRE, SA (BARCELONA PLANT)

LABORATORIO REIG JOFRE SA

Injectable (lyo and liquid) and Liquid manufacturing facilities.

BSL (Biological Safety Level): 3, 1, 2

MARKETS: EMA (EU), PMDA (Japan), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MHRA (UK), INVIMA (Colombia), MFDS (South Korea), TGA (Australia)

REGION: Europe

BATCH SIZE: Large, Medium

USE: Human, Veterinary

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

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

CONTROLLED SUBSTANCES: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

COMPLIANCE: PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), ECOVADIS, INVIMA, ISP (Chile BPM), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)

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

Sylentis
Spain

Sylentis

Sylentis

Oligonucleotide manufacturer.

COMPLIANCE: ICH, FDA (cGMP), ISO, EMA (EU GMP), World Health Organization (GMP / HACCP)

MARKETS: EMA (EU), FDA (USA)

REGION: Europe

BATCH SIZE: Large, Small, Medium

USE: Human, Veterinary

CATEGORY / PRODUCT: OLIGONUCLEOTIDES

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

OEB (Occupational Exposure Banding): 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)

VIVEbiotech
Spain

VIVEbiotech

VIVEbiotech

Your leading GMP-certified CDMO exclusively dedicated to the production of lentiviral vectors.

MARKETS: EMA (EU), FDA (USA), MHRA (UK)

REGION: Europe

COMPLIANCE: FDA (cGMP), French Service-Public (CIR), EMA (EU GMP), MHRA (UK GMP)

BATCH SIZE: Large, Small, Medium

USE: Human

BSL (Biological Safety Level): 1, 2

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

CATEGORY / PRODUCT: BIOLOGICS

Viswa Laboratories Pvt Ltd
India

Viswa Laboratories Pvt Ltd

Viswa Laboratories Private Limited

CRAMS/CDMO, APIs, Intermediates and specialty chemicals.

MARKETS: EMA (EU), NMPA (China), ANVISA (Brazil), Russian Health Authorities, CDSCO (India)

REGION: APAC

BATCH SIZE: Large, Small, Medium

USE: Human, Veterinary

BSL (Biological Safety Level): 1, 2

CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC

SERVICES: Development services, Manufacturing services

THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (R) Respiratory system

CONTROLLED SUBSTANCES: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

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)

COMPLIANCE: World Health Organization (GMP / HACCP)

Pharmaron API Commercial Synthesis Shaoxing (China)
China

Pharmaron API Commercial Synthesis Shaoxing (China)

Pharmaron

Commercial API Small Molecules /Peptides Synthesis.

THERAPEUTIC AREAS OF EXPERTISE (ATC): (V04) Diagnostic agents, (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V01) Allergens, (V06) Nutrients, (V09-10) Radiopharmaceuticals, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

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: NMPA (China), FDA (USA)

REGION: APAC

COMPLIANCE: FDA (cGMP), ISO, NMPA (China GMP)

BATCH SIZE: Large, Small, Medium

USE: Human, Veterinary

CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC

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

Pharmaron API Commercial Synthesis Cramlington (UK)
United Kingdom

Pharmaron API Commercial Synthesis Cramlington (UK)

Pharmaron

Commercial API Small Molecules Synthesis.

THERAPEUTIC AREAS OF EXPERTISE (ATC): (V04) Diagnostic agents, (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V01) Allergens, (V06) Nutrients, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

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), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), TGA (Australia)

REGION: Europe

COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), TGA (Australia GMP), EMA (EU GMP), Health Canada (Canada GMP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)

BATCH SIZE: Large, Small, Medium

USE: Human, Veterinary

CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC

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

OEB (Occupational Exposure Banding): 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)

Pharmaron API Commercial Synthesis Coventry (US)
United States

Pharmaron API Commercial Synthesis Coventry (US)

Pharmaron

Commercial API Small Molecules Synthesis.

THERAPEUTIC AREAS OF EXPERTISE (ATC): (V04) Diagnostic agents, (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V01) Allergens, (V06) Nutrients, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

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), PMDA (Japan), FDA (USA), Health Canada (Canada), MHRA (UK), MFDS (South Korea), TGA (Australia)

COMPLIANCE: FDA (cGMP), ISO, ECOVADIS

BATCH SIZE: Large, Small, Medium

USE: Human, Veterinary

CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC

SERVICES: Development services, Manufacturing services

OEB (Occupational Exposure Banding): 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)

REGION: North America

HIPRA BIOTECH SERVICES | Amer
Spain

HIPRA BIOTECH SERVICES | Amer

HIPRA Biotech Services

End-to-end internal capabilities from cell line development to commercial manufacturing.

MARKETS: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia)

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

REGION: Europe

COMPLIANCE: DIGEMID, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, INVIMA, ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP)

BATCH SIZE: Large, Small, Medium

USE: Human, Veterinary

BSL (Biological Safety Level): 1, 2

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: BIOLOGICS, FDF / DRUG PRODUCTS

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When your product is ready for wide-scale commercial launch or global distribution, you need the infrastructure, compliance, and capacity to produce consistently at scale. That’s where large batch size CDMO companies come in. These partners are equipped to deliver high-volume, cost-efficient, and globally compliant manufacturing across a wide range of dosage forms.

Through fully integrated large batch size contract manufacturing services, these CDMOs help pharmaceutical and biotech companies meet growing demand while maintaining product quality, regulatory alignment, and supply chain efficiency.

How to Choose Large Batch Size CDMO Companies

When selecting large batch size CDMO companies, consider:

  • Commercial-scale manufacturing capacity for your specific dosage form
  • High-speed production lines for tablets, capsules, liquids, injectables, or biologics
  • Automation and continuous manufacturing technologies
  • Global GMP certifications (FDA, EMA, TGA, PMDA, WHO)
  • Proven track record in tech transfer and process validation
  • Advanced packaging, labeling, and serialization capabilities
  • Integrated quality and regulatory systems for audit readiness

The ideal CDMO ensures uninterrupted supply, scalability, and global market access.

Key Services Offered by Large Batch Size Contract Manufacturers

Top-tier large batch size contract manufacturing services include:

  • Process optimization and tech transfer from development or pilot scale
  • High-capacity blending, granulation, compression, and coating
  • Sterile filling and biologics production under isolator or RABS systems
  • Lyophilization, aseptic processing, and controlled environments
  • Automated packaging lines for bottles, blisters, vials, and syringes
  • Cold chain logistics and warehousing for global distribution
  • Batch documentation, stability programs, and regulatory filings

These services support large-scale supply of generic, branded, OTC, and biologic products across all major markets.

Advantages of Partnering with Large Batch Size CDMO Companies

Working with experienced large batch size CDMO companies offers:

  • Significant cost-per-unit reduction at scale
  • Reliable high-volume output with consistent quality
  • Global regulatory compliance across jurisdictions
  • Speed to market with integrated, end-to-end capabilities
  • Flexible capacity planning for launches, tenders, or seasonal demand

These CDMOs are built to deliver your product at the speed, volume, and quality today’s markets demand.

Large Batch Size CDMO Companies

Some of the most trusted large batch size CDMO companies include:

  • HIPRA BIOTECH SERVICES: End-to-end internal capabilities from cell line development to commercial manufacturing. [See CDMO profile]

  • Skyepharma: Development and delivery of oral technologies serving the global pharmaceutical, biotech and consumer health industries. [See CDMO profile]

  • Ophtapharm, a Sentiss Company: Ophthalmic and Otic – solutions, suspensions, emulsions, ointments and gels – FDA approved facility. [See CDMO profile]

  • CARBOGEN AMCIS: Highly potent APIs development and small-scale cGMP production including chromatography and lyophilization. [See CDMO profile]

  • Sichuan Huiyu Pharmaceuticals Co., Ltd: Manufacturing site and formulation manufacturing site, supported by an R&D center developing APIs and finished dosage forms. [See CDMO profile]

  • AdhexPharma SAS: CDMO for transdermal patches and oromucosal films. [See CDMO profile]

  • Sylentis: Oligonucleotide manufacturer. [See CDMO profile]

  • Apeloa Pharmaceutical Co., Ltd: Development and manufacturing of APIs, intermediates and registered starting materials. [See CDMO profile]

  • Glatt Pharmaceutical Services GmbH Co. & KG: cGMP-compliant CDMO for end-to-end services in complex oral solid dosage forms. [See CDMO profile]

  • Darnytsia Kyiv: CMO combining advanced facilities, stringent quality control and expert staff to deliver reliable, compliant and innovative solutions. [See CDMO profile]

  • Basic Pharma Manufacturing: Analytical testing and regulatory support tailored to customer needs, following relevant quality guidelines. [See CDMO profile]

  • Adragos Pharma: More than 100 years of experience providing first-class service and customer-focused manufacturing. [See CDMO profile]

  • Cellex Cell Professionals: CGT CDMO with cell manufacturing plant and collection center for starting materials. [See CDMO profile]

  • Ascendia Pharmaceutical Solutions: GMP-certified CDMO for advanced sterile and non-sterile manufacturing, formulation development and analytical testing. [See CDMO profile]

  • MENADIONA S.L: APIs, intermediates and fine chemicals, specializing in transferring R&D projects into full cGMP manufacturing processes. [See CDMO profile]

  • i+Med: Developer and manufacturer of new drug products with controlled release technologies. [See CDMO profile]

  • Liof Pharma S.L.U.: CDMO partner for aseptic manufacturing and lyophilization of biologics and injectable drugs. [See CDMO profile]

  • Content Group: Tubilux Pharma: registered office and manufacturing facility. [See CDMO profile]

  • Aenova: CDMO for high volume manufacturing of conventional solids. [See CDMO profile]

  • CDM Lavoisier: Large batch size of glass ampoules, glass vials and plastic (BFS) ampoules. [See CDMO profile]

  • Cambrex: CDMO for intermediates and custom APIs at commercial scale. [See CDMO profile]

  • Lannett CDMO: Main manufacturing site with OSD and liquids capabilities. [See CDMO profile]

  • Cenexi: Specializes in sterile highly potent injectables, mainly oncology. [See CDMO profile]

  • Viswa Laboratories: CRAMS/CDMO, APIs, intermediates and specialty chemicals. [See CDMO profile]

  • Pharmaloop: Fully integrated CDMO for BFS, sterile and non-sterile formats, sachets, capsules and tablets. [See CDMO profile]

  • FAES FARMA: Developer and manufacturer of human medicinal products at commercial scale. [See CDMO profile]

  • Grifols: Sterile large batch-size solutions in flexible bags and vials. [See CDMO profile]

  • Pharmaron: Small molecule (RSM/API) commercial facility. [See CDMO profile]

  • VIVUNT PHARMA: CDMO for sterile oncology drugs. [See CDMO profile]

  • Shilpa Biologicals: CDMO supporting end-to-end biologics development and manufacturing. [See CDMO profile]

  • Reig Jofre: Betalactam antibiotics (FDF) development and manufacturing. [See CDMO profile]

  • Mabion: Fully integrated CDMO for biotherapeutics, including large batch manufacturing. [See CDMO profile]

  • 53Biologics: CDMO for biologics from DNA to proteins, preclinical to cGMP commercial manufacturing. [See CDMO profile]

  • VIVEbiotech: GMP-certified CDMO exclusively for lentiviral vector production. [See CDMO profile]

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Let MAI CDMO Help You Find the Right Large Batch Size CDMO Partner

At MAI CDMO, we connect pharma and biotech companies with high-capacity large batch size CDMO companies offering end-to-end large batch size contract manufacturing services. Whether you’re launching globally, entering high-demand markets, or fulfilling public health tenders, we’ll match you with a partner ready to scale with your growth.

Need a commercial-scale manufacturing partner? Contact us today to find the ideal CDMO for your volume, quality, and market needs.