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Pharmaron API Commercial Synthesis Shaoxing (China)
中国

Pharmaron API Commercial Synthesis Shaoxing (China)

Pharmaron

商业 API 小分子/肽合成。

专业治疗领域 (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(职业暴露带): 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)

市场: NMPA (China), FDA (USA)

地区: 亚太地区

遵守: FDA (cGMP), ISO, NMPA (China GMP)

批量大小: Large, Small, Medium

使用: Human, Veterinary

类别/产品: 化学合成

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

专业治疗领域 (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

受控物质: 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

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

地区: 欧洲

遵守: 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)

批量大小: Large, Small, Medium

使用: Human, Veterinary

类别/产品: 化学合成

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

OEB(职业暴露带): 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)

专业治疗领域 (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

受控物质: 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

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

遵守: FDA (cGMP), ISO, ECOVADIS

批量大小: Large, Small, Medium

使用: Human, Veterinary

类别/产品: 化学合成

服务: Development services, Manufacturing services

OEB(职业暴露带): 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)

地区: 北美

HIPRA BIOTECH SERVICES | Amer
西班牙

HIPRA BIOTECH SERVICES | Amer

HIPRA Biotech Services

从细胞系开发到商业制造的端到端内部能力。

市场: 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)

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

地区: 欧洲

遵守: 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)

批量大小: Large, Small, Medium

使用: Human, Veterinary

BSL(生物安全等级): 1, 2

OEB(职业暴露带): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

类别/产品: 生物制剂, FDF / 药品

BAG Health Care
德国

BAG Health Care

BAG Health Care GmbH

注射用 F&F 供应商,提供中小批量的小瓶注射剂。

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

地区: 欧洲

使用: Human, Veterinary

BSL(生物安全等级): 1

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

OEB(职业暴露带): 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)

批量大小: Small, Medium

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

类别/产品: FDF / 药品

Lifecore Injectables CDMO
美国

Lifecore Injectables CDMO

Lifecore Biomedical

生产临床和商业无菌注射药品的 CDMO。

BSL(生物安全等级): 3, 1, 2

市场: 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

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

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

批量大小: Large, Small, Medium

使用: Human, Veterinary

受控物质: Lowest potential for abuse

OEB(职业暴露带): 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)

地区: 北美

类别/产品: FDF / 药品

53Biologics Production Plant
西班牙

53Biologics Production Plant

53Biologics

53Biologics 是一家西班牙 CDMO,专门从事从 DNA 到蛋白质等生物制品生产的解码。

市场: 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)

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

地区: 欧洲

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

批量大小: Large, Small, Medium

使用: Human, Veterinary

BSL(生物安全等级): 1, 2

类别/产品: 生物制剂

BDI biotech Production Plant
西班牙

BDI biotech Production Plant

BDI biotech

我们是一个专门从事菌株和生物工艺开发、放大和批量生产的研发部门。

市场: 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)

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

地区: 欧洲

遵守: ISO

BSL(生物安全等级): 1

批量大小: Small, Medium

类别/产品: 生物制剂

Laboratorios Grifols | Murcia Plant
西班牙

Laboratorios Grifols | Murcia Plant

Grifols International

软袋中的无菌制造解决方案(小分子)。

市场: EMA (EU), FDA (USA), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea), TGA (Australia)

服务: Logistics, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging

地区: 欧洲

遵守: 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)

批量大小: Large, Small, Medium

使用: Human, Veterinary

专业治疗领域 (ATC): (C) Cardiovascular system, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (A) Digestive tract and metabolism

受控物质: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

OEB(职业暴露带): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

类别/产品: FDF / 药品

EVER Pharma Jena GmbH
德国

EVER Pharma Jena GmbH

EVER Neuro Pharma GmbH

用于开发和生产小分子注射剂的专业 CDMO。

OEB(职业暴露带): 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)

受控物质: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

市场: 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

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

地区: 欧洲

遵守: 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)

批量大小: Large, Small, Medium

使用: Human

BSL(生物安全等级): 1, 2

专业治疗领域 (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins, (L) Antineoplastic and immunomodulating agents, (N) Nervous system

类别/产品: FDF / 药品

ALPHAVET Zrt.- Bábolna Manufacturing Plant
匈牙利

ALPHAVET Zrt.- Bábolna Manufacturing Plant

Alphavet Zrt.

该工厂已获得欧盟 GMP 认证,为 18 个欧盟成员国和欧盟以外的其他 7 个欧洲国家生产兽药产品。

市场: EMA (EU)

地区: 欧洲

遵守: ISO, EMA (EU GMP)

批量大小: Large, Medium

类别/产品: 营养保健品, FDF / 药品

使用: Veterinary

服务: Manufacturing services, Analytical / QC services, Regulatory services, Packaging

Avara Pharmaceutical Services | Arecibo Site
美国

Avara Pharmaceutical Services | Arecibo Site

AVARA

商业规模的口服固体制剂 (OSD) 生产设施,在受控物质 (DEA II V) 方面拥有丰富的专业知识。

受控物质: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

遵守: ICH, FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), EMA (EU GMP), Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)

市场: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, MFDS (South Korea), TGA (Australia)

批量大小: Large, Medium

使用: Human

类别/产品: 化学合成, 服务, FDF / 药品, 粒子工程

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

专业治疗领域 (ATC): (C) Cardiovascular system, (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, (R) Respiratory system, (S) Sensory organs, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

地区: 北美

OEB(职业暴露带): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

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