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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

White Raven - Legiapark
Belgium

White Raven - Legiapark

White Raven

Fill and finish site dedicated to GMP Formulation and the Aseptic filling of Sterile Liquid Injectables.

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)

REGION: Europe

USE: Human

BSL (Biological Safety Level): 1, 2

SERVICES: Manufacturing services, Packaging

BATCH SIZE: Small, Medium

COMPLIANCE: EMA (EU GMP)

CATEGORY / PRODUCT: BIOLOGICS, 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)

Upperton Pharma Solutions
United Kingdom

Upperton Pharma Solutions

Upperton Pharma Solutions

Development and manufacturing of oral solid dose (OSD), nasal, inhalation, and sterile dry powders and liquids drug products.

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)

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), Health Canada (Canada), MHRA (UK), TGA (Australia)

REGION: Europe

USE: Human

CATEGORY / PRODUCT: OLIGONUCLEOTIDES, BIOLOGICS, SERVICES, FDF / DRUG PRODUCTS

BSL (Biological Safety Level): 1

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

THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (N) Nervous system, (R) Respiratory system

BATCH SIZE: Small, Medium

COMPLIANCE: MHRA (UK GMP)

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

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)

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

BAG Health Care
Germany

BAG Health Care

BAG Health Care GmbH

Parenteral F&F provider for vials in small to mid sized batches.

MARKETS: EMA (EU), MHRA (UK), TGA (Australia)

REGION: Europe

USE: Human, Veterinary

BSL (Biological Safety Level): 1

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

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)

BATCH SIZE: Small, Medium

COMPLIANCE: EMA (EU GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP)

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

53Biologics Production Plant
Spain

53Biologics Production Plant

53Biologics

53Biologics is a Spanish CDMO specialized in decoding the production of biologicals, from DNA to proteins.

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

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

REGION: Europe

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

BATCH SIZE: Large, Small, Medium

USE: Human, Veterinary

BSL (Biological Safety Level): 1, 2

CATEGORY / PRODUCT: BIOLOGICS

BDI biotech Production Plant
Spain

BDI biotech Production Plant

BDI biotech

We work as an R&D department specialized in strain and bioprocess development, scale-up and batches production.

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

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

REGION: Europe

COMPLIANCE: ISO

BSL (Biological Safety Level): 1

BATCH SIZE: Small, Medium

CATEGORY / PRODUCT: BIOLOGICS