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Sichuan Huiyu Pharmaceuticals Co., Ltd. - API Manufacturing Site
Seacross Pharmaceutical Co Ltd
As one of three core sites, alongside the R&D center and formulation plant, our API manufacturing facility plays a vital role in the integrated supply chain.
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), 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), Rest of World
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: APAC
COMPLIANCE: DIGEMID, BRCGS, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Halal Research Council, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ISP (Chile BPM), French Service-Public (CIR), NMPA (China GMP), 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), SQF (Safe Quality Food), NSF
BATCH SIZE: Large, Small, Medium
USE: Human
BSL (Biological Safety Level): 1, 2, 3, 4
CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC
THERAPEUTIC AREAS OF EXPERTISE (ATC): (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, (V04) Diagnostic agents
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), 5 / HPAPI (PDE < 10 µg/day)
Sichuan Huiyu Pharmaceuticals Co., Ltd. - R&D Site
Seacross Pharmaceutical Co Ltd
The R&D Center plays a fundamental role in supporting the development of both APIs and finished dosage forms.
COMPLIANCE: MFDS/KFDA (Republic of Korea GMP), SQF (Safe Quality Food), NSF, DIGEMID, BRCGS, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Halal Research Council, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ISP (Chile BPM), French Service-Public (CIR), NMPA (China GMP), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP)
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day), 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)
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
BSL (Biological Safety Level): 3, 4, 1, 2
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), 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), Rest of World
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: APAC
BATCH SIZE: Large, Small, Medium
USE: Human
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.
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
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)
BSL (Biological Safety Level): 3, 4, 1, 2
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), 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), Rest of World
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: APAC
COMPLIANCE: DIGEMID, BRCGS, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Halal Research Council, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ISP (Chile BPM), French Service-Public (CIR), NMPA (China GMP), 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), SQF (Safe Quality Food), NSF
BATCH SIZE: Large, Small, Medium
USE: Human
CATEGORY / PRODUCT: SERVICES, FDF / DRUG PRODUCTS
Cenexi
Cenexi
GMP plant on a four-hectare site is located 9 km east of Paris. It is a center of excellence for injectable ampoules.
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), EDE (UAE), TGA (Australia)
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), NMPA (China GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)
BATCH SIZE: Large, Small, Medium
USE: Human, Veterinary
THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (A) Digestive tract and metabolism
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)
Cenexi Hérouville Saint Clair
Cenexi
The Hérouville-Saint-Clair site, located near Caen, in Normandy, specializes in the manufacture and filling of injectable and non-injectable sterile liquids.
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), ANVISA (Brazil), Russian Health Authorities, MHRA (UK), MFDS (South Korea), TGA (Australia)
REGION: Europe
COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), NMPA (China GMP), EMA (EU GMP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)
USE: Human
SERVICES: Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (N) Nervous system, (A) Digestive tract and metabolism
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
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS
Cenexi Laboratoires Thissen
Cenexi
This 8,000 m2 plant, with buildings dotted around a site of nearly seven hectares, is located 20 km south of Brussels and has 340 employees*.
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)
BSL (Biological Safety Level): 3, 4, 1, 2
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), MHRA (UK), MFDS (South Korea), TGA (Australia)
REGION: Europe
COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), NMPA (China 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
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
THERAPEUTIC AREAS OF EXPERTISE (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins, (L) Antineoplastic and immunomodulating agents, (G) Genito urinary system and sex hormones
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS
OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day)
BSL (Biological Safety Level): 3, 4
CONTROLLED SUBSTANCES: High potential for abuse & medical use
COMPLIANCE: ICH, ISO, ANVISA (Brazil B-GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), NMPA (China GMP), EMA (EU GMP)
MARKETS: EMA (EU), NMPA (China), ANVISA (Brazil), MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
BATCH SIZE: Large, Small, Medium
USE: Human
THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS
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