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Seans 52 udogodnienia
Laboratorio REIG JOFRE, SA (TOLEDO PLANT)
Hiszpania

Laboratorio REIG JOFRE, SA (TOLEDO PLANT)

LABORATORIO REIG JOFRE SA

Rozwój i produkcja antybiotyków betalaktamowych (FDF) w najnowocześniejszych zakładach.

Batch Size: Large, Medium

Use: Human, Veterinary

BSL (Biological Safety Level): 1

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

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

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

Therapeutic Areas of Expertise (ATC): (J) Antiinfectives for systemic use

Controlled Substances: Lowest potential for abuse

Category / Product: FDF / DRUG PRODUCTS

OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)

Region: Europe

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

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

Seacross Pharmaceutical Co Ltd

Zakład produkcyjny receptur zajmuje się opracowywaniem i produkcją złożonych postaci dawkowania o wysokiej wartości.

Batch Size: Large, Small, Medium

Use: Human

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

Compliance: ISO, FDA (cGMP), DIGEMID, BRCGS, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Halal Research Council, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ECOVADIS, ISP (Chile BPM), French Service-Public (CIR), World Health Organization (GMP / HACCP), EMA (EU GMP), NMPA (China GMP), Health Canada (Canada GMP), MHRA (UK GMP), ANMAT (Argentina nueva GMP), MFDS/KFDA (Republic of Korea GMP), NSF, SQF (Safe Quality Food)

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

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

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

Controlled Substances: Lowest potential for abuse, Lower potential for abuse, High potential for abuse & no medical use, Low potential for abuse, High potential for abuse & medical use

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

Category / Product: SERVICES, FDF / DRUG PRODUCTS

Region: APAC

Lifecore Injectables CDMO
Stany Zjednoczone

Lifecore Injectables CDMO

Lifecore Biomedical

CDMO produkująca sterylne produkty lecznicze do wstrzykiwań do użytku klinicznego i komercyjnego.

Batch Size: Large, Small, Medium

Use: Human, Veterinary

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

Compliance: ISO, FDA (cGMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), ECOVADIS, EMA (EU GMP), Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)

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

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

Controlled Substances: Lowest potential for abuse

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

Category / Product: FDF / DRUG PRODUCTS

Region: North America

Cenexi Hérouville Saint Clair
Francja

Cenexi Hérouville Saint Clair

Cenexi

Zakład w Hérouville-Saint-Clair, zlokalizowany w pobliżu Caen w Normandii, specjalizuje się w produkcji i rozlewaniu sterylnych płynów do iniekcji i nie do inie

Use: Human

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

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

Services: Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging

Therapeutic Areas of Expertise (ATC): (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (C) Cardiovascular system, (A) Digestive tract and metabolism

Controlled Substances: Lowest potential for abuse, Lower potential for abuse, High potential for abuse & no medical use, Low potential for abuse, High potential for abuse & medical use

Batch Size: Small, Medium

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

Category / Product: FDF / DRUG PRODUCTS

Region: Europe

CZ Vaccines | Large Scale Plant Portugal
Portugalia

CZ Vaccines | Large Scale Plant Portugal

CZ Vaccines

Obiekt na skalę komercyjną

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

Markets: EMA (EU)

Compliance: ISO, EMA (EU GMP), World Health Organization (GMP / HACCP)

BSL (Biological Safety Level): 1, 2

Use: Human

Batch Size: Large, Medium

Therapeutic Areas of Expertise (ATC): (J) Antiinfectives for systemic use, (R) Respiratory system, (G) Genito urinary system and sex hormones

Category / Product: FDF / DRUG PRODUCTS, BIOLOGICS

Region: Europe

Cenexi
Francja

Cenexi

Cenexi

Zakład GMP na czterohektarowym terenie położony jest 9 km na wschód od Paryża. Jest to centrum doskonałości w zakresie ampułek do wstrzykiwań.

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 > 5,000 µg/day)

Region: Europe

HIPRA BIOTECH SERVICES | Amer
Hiszpania

HIPRA BIOTECH SERVICES | Amer

HIPRA Biotech Services

Kompleksowe możliwości wewnętrzne, od rozwoju linii komórkowych po produkcję komercyjną.

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

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)

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)

BSL (Biological Safety Level): 1, 2

Use: Human, Veterinary

Batch Size: Large, Small, Medium

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

Category / Product: FDF / DRUG PRODUCTS, BIOLOGICS

Region: Europe

Bilthoven Biologicals Drug Substance and Drug Product Facilities
Holandia

Bilthoven Biologicals Drug Substance and Drug Product Facilities

Bilthoven Biologicals BV

Wieloproduktowe obiekty GMP dla substancji i produktów leczniczych.

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

Markets: EMA (EU), MHRA (UK)

BSL (Biological Safety Level): 1, 2

Use: Human

Batch Size: Large, Small, Medium

Compliance: EMA (EU GMP)

Category / Product: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS

Region: Europe

HBM Pharma
Słowacja

HBM Pharma

Hbm Pharma

CMO z certyfikatem GMP UE z siedzibą w Martinie na Słowacji. Firma świadczy usługi produkcyjne i konfekcjonowania sterylnych produktów farmaceutycznych. produkty i stałe doustne postacie dawkowania

Markets: EMA (EU), NMPA (China), Health Canada (Canada), ANVISA (Brazil), COFEPRIS (Mexico), Russian Health Authorities, MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities, TGA (Australia)

Compliance: ISO, Roszdravnadzor (Russia GMP), ECOVADIS, TGA (Australia GMP), UAE Ministry of Health & Prevention, NMPA (China GMP), EMA (EU GMP), Health Canada (Canada GMP), ANVISA (Brazil)

Use: Human

Batch Size: Large, Small, Medium

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

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

Controlled Substances: High potential for abuse & medical use

Category / Product: FDF / DRUG PRODUCTS, SERVICES

Region: Europe

Laboratorio REIG JOFRE, SA (BARCELONA PLANT)
Hiszpania

Laboratorio REIG JOFRE, SA (BARCELONA PLANT)

LABORATORIO REIG JOFRE SA

Zakłady produkujące produkty do wstrzykiwania (lyo i płyn) oraz płynne.

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 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day)

Category / Product: FDF / DRUG PRODUCTS

EVER Pharma Jena GmbH
Niemcy

EVER Pharma Jena GmbH

EVER Neuro Pharma GmbH

Specjalistyczne CDMO do opracowywania i produkcji małocząsteczkowych preparatów do wstrzykiwań.

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

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), 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), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia), Reszta świata

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

Region: Europe

Compliance: ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), NMPA (China GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)

Batch Size: Large, Small, Medium

Use: Human

BSL (Biological Safety Level): 1, 2

Therapeutic Areas of Expertise (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins, (L) Antineoplastic and immunomodulating agents, (N) Nervous system

Category / Product: FDF / DRUG PRODUCTS

Markets: EMA (EU), ANVISA (Brazil), CDSCO (India)

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

Region: Europe

Compliance: ISO, ANVISA (Brazil B-GMP), EMA (EU GMP), World Health Organization (GMP / HACCP)

Use: Human

BSL (Biological Safety Level): 1, 2

Therapeutic Areas of Expertise (ATC): (R) Respiratory system, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

Batch Size: Small

Category / Product: BIOLOGICS, FDF / DRUG PRODUCTS

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