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Showing 11 facilities
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 Latina, Italy
Italy

Aenova Group - Location Latina, Italy

Aenova

Competence Center animal health products and sterile technologies.

MARKETS: Turkish Health Authorities, ANVISA (Brazil), FDA (USA), Russian Health Authorities, EMA (EU), SFDA (Saudi Arabia)

BATCH SIZE: Small, Medium, Large

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (EU GMP), ANVISA (Brazil B-GMP), FDA (cGMP), SFDA (Saudi Food & Drug Authority), TITCK (Turkish Health Authorities)

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)

BSL (Biological Safety Level): 1, 2

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

Seda Pharma Development Services
United Kingdom

Seda Pharma Development Services

Seda Pharma Development Services Ltd

Seda Pharmaceutical Development Services specialises in integrated Pharmaceutical Development and Clinical Pharmacology.

MARKETS: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), Rest of World, ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), 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

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

REGION: Europe

USE: Human

COMPLIANCE: MHRA (UK GMP), ECOVADIS

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)

THERAPEUTIC AREAS OF EXPERTISE (ATC): (M) Musculoskeletal system, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system, (B) Blood and blood forming organs

Sichuan Huiyu Pharmaceuticals Co., Ltd. - Formulation Manufacturing Site
China

Sichuan Huiyu Pharmaceuticals Co., Ltd. - Formulation Manufacturing Site

Seacross Pharmaceutical Co Ltd

The Formulation Manufacturing Site is dedicated to the development and production of complex, high-value dosage forms.

MARKETS: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), Rest of World, ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), 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

THERAPEUTIC AREAS OF EXPERTISE (ATC): (R) Respiratory system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (V01) Allergens, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (V04) Diagnostic agents, (S) Sensory organs, (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, (P) Antiparasitic products, insecticides and repellents, (B) Blood and blood forming organs, (V06) Nutrients

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES

COMPLIANCE: ISP (Chile BPM), Roszdravnadzor (Russia GMP), ANMAT (Argentina nueva GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), IFS, DIGEMID, 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), NSF, NMPA (China GMP), SFDA (Saudi Food & Drug Authority), BRCGS, ECOVADIS, ISO, Halal Research Council, INVIMA, Health Canada (Canada GMP), SQF (Safe Quality Food), TITCK (Turkish Health Authorities), MSPAS, MFDS/KFDA (Republic of Korea GMP), COFEPRIS

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

BSL (Biological Safety Level): 3, 4, 1, 2

USE: Human

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

REGION: APAC

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)

STE PRASFARMA
Spain

STE PRASFARMA

STE PRASFARMA

CMO/CDMO cytostatics and high potency products.

MARKETS: Turkish Health Authorities, ANVISA (Brazil), EMA (EU), SFDA (Saudi Arabia), NMPA (China), MHRA (UK)

BATCH SIZE: Small, Medium, Large

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

COMPLIANCE: EMA (EU GMP), ANVISA (Brazil B-GMP), NMPA (China GMP), SFDA (Saudi Food & Drug Authority), ISO, TITCK (Turkish Health Authorities), ICH

REGION: Europe

BSL (Biological Safety Level): 3, 4

USE: Human

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

CONTROLLED SUBSTANCES: High potential for abuse & medical use

OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day)

THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents

Limited view

FDF / DRUG PRODUCTS manufacturing site

MAI network supplier

One-stop CDMO Solutions for APl and Key intermediates.

Location available after registration

Limited view

FDF / DRUG PRODUCTS manufacturing site

MAI network supplier

French CDMO key player in drug development and delivery of oral technologies serving the pharma and bio industries.

Location available after registration

Limited view

FDF / DRUG PRODUCTS manufacturing site

MAI network supplier

Chemical-Pharmaceutical Facility

Location available after registration

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