小批量 CDMO 公司|
小批量合同制造服务

您值得信赖的小批量合同制造和开发合作伙伴

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中国

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

Seacross Pharmaceutical Co Ltd

制剂生产基地致力于复杂、高价值剂型的开发和生产。

发现我们的设施

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

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), INVIMA, ECOVADIS, ISP (Chile BPM), French Service-Public (CIR), World Health Organization (GMP / HACCP), NMPA (China GMP), Health Canada (Canada GMP), MHRA (UK GMP), ANMAT (Argentina nueva GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP), NSF, SQF (Safe Quality Food), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority)

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

Therapeutic Areas of Expertise (ATC): (V04) Diagnostic agents, (B) Blood and blood forming organs, (D) Dermatologicals, (J) Antiinfectives for systemic use, (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: FDF / DRUG PRODUCTS, SERVICES

Region: APAC

意大利

Aenova Group - Location Latina, Italy

Aenova

动物保健产品和无菌技术能力中心。

发现我们的设施

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

Batch Size: Large, Small, Medium

Use: Human, Veterinary

BSL (Biological Safety Level): 1, 2

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

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

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

Region: Europe

中国

Sichuan Huiyu Pharmaceuticals Co., Ltd. - R&D Site

Seacross Pharmaceutical Co Ltd

研发中心在支持原料药和成品剂型的开发方面发挥着基础性作用。

发现我们的设施

Batch Size: Large, Small, Medium

Use: Human

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

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

Therapeutic Areas of Expertise (ATC): (V04) Diagnostic agents, (V09-10) Radiopharmaceuticals, (B) Blood and blood forming organs, (D) Dermatologicals, (J) Antiinfectives for systemic use, (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

Category / Product: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC

Region: APAC

斯洛文尼亚

JAFRAL

综合生物技术设施为先进生物制品提供研发、非 GMP 和 GMP 制造、质量控制测试以及灌装和加工服务。

发现我们的设施

Markets: Health Canada (Canada), ANVISA (Brazil), FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK), CDSCO (India), Turkish Health Authorities, EDE (UAE), SFDA (Saudi Arabia), TGA (Australia)

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

Batch Size: Large, Small, Medium

Use: Human, Veterinary

BSL (Biological Safety Level): 1, 2

Compliance: ISO, ICH, FDA (cGMP), World Health Organization (GMP / HACCP), EMA (EU GMP), SQF (Safe Quality Food)

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

Controlled Substances: Lowest potential for abuse

Therapeutic Areas of Expertise (ATC): (D) Dermatologicals, (J) Antiinfectives for systemic use, (V06) Nutrients, (R) Respiratory system, (A) Digestive tract and metabolism

Region: Europe

希腊

Adragos Pharma | Athens

Adragos Pharma

专门从事增值药品的开发，最近已升级为 HPAPI 功能。

发现我们的设施

Markets: Health Canada (Canada), ANVISA (Brazil), FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), MHRA (UK), CDSCO (India), EDE (UAE), SFDA (Saudi Arabia), ANMAT (Argentina), MFDS (South Korea), TGA (Australia)

Batch Size: Large, Small, Medium

Use: Human

Compliance: ISO, FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), NMPA (China GMP), MHRA (UK GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP), NSF, UAE Ministry of Health & Prevention

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

Controlled Substances: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse, High potential for abuse & medical use

Category / Product: FDF / DRUG PRODUCTS, SERVICES

Region: Europe

印度

HIKAL | Mumbai

Hikal Ltd.

Hikal 是一家领先的制药 CDMO，专门从事小分子、HPAPI、工艺开发、定制合成和商业制造。

发现我们的设施

Markets: Health Canada (Canada), ANVISA (Brazil), FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), MHRA (UK), CDSCO (India), Turkish Health Authorities, EDE (UAE), SFDA (Saudi Arabia), ANMAT (Argentina), MFDS (South Korea), TGA (Australia), 世界其他地区

Batch Size: Large, Small, Medium

Use: Human, Veterinary

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

Compliance: ISO, ICH, FDA (cGMP), PMDA/MHLW (Japan GMP), TGA (Australia GMP), ECOVADIS, World Health Organization (GMP / HACCP), Health Canada (Canada GMP), MHRA (UK GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP), PMDA (Japan), ANVISA (Brazil), Health Canada

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

Category / Product: SERVICES, CHEMICAL-SYNTHETIC

Region: APAC

英国

CARBOGEN AMCIS | Manchester, UK

CARBOGEN AMCIS

了解我们的化妆品成分制造能力、精细化学品和医药中间体定制合成能力。

发现我们的设施

Batch Size: Large, Small, Medium

Services: Development services, Analytical / QC services, Manufacturing services

Compliance: ISO, Halal Research Council, ECOVADIS

Category / Product: SERVICES, PARTICLE ENGINEERING, CHEMICAL-SYNTHETIC

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

Region: Europe

法国

CARBOGEN AMCIS | Saint-Beauzire

CARBOGEN AMCIS

液体和冻干药品的定制配方开发和 GMP 无菌生产。

发现我们的设施

Batch Size: Large, Small, Medium

Use: Human

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

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

Compliance: ISO, FDA (cGMP), ANVISA (Brazil B-GMP), PMDA/MHLW (Japan GMP), TGA (Australia GMP), French Service-Public (CIR), ANMAT (Argentina nueva GMP), Health Canada (Canada GMP), MHRA (UK GMP), World Health Organization (GMP / HACCP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority)

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

Therapeutic Areas of Expertise (ATC): (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (S) Sensory organs, (R) Respiratory 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

Category / Product: FDF / DRUG PRODUCTS

Region: Europe

瑞士

CARBOGEN AMCIS | Neuland

CARBOGEN AMCIS

开发和中等规模制造。

发现我们的设施

Use: Human, Veterinary

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

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

Compliance: FDA (cGMP), PMDA/MHLW (Japan GMP), World Health Organization (GMP / HACCP)

Batch Size: 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: SERVICES, CHEMICAL-SYNTHETIC

Region: Europe

荷兰

CARBOGEN AMCIS | Veenendaal

CARBOGEN AMCIS

大规模生产胆固醇和维生素 D 类似物。

发现我们的设施

Use: Human, Veterinary

BSL (Biological Safety Level): 1

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

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), 世界其他地区

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

Therapeutic Areas of Expertise (ATC): (V04) Diagnostic agents, (B) Blood and blood forming organs, (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (S) Sensory organs, (V09-10) Radiopharmaceuticals, (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

Batch Size: Small

Category / Product: SERVICES, CHEMICAL-SYNTHETIC

Region: Europe

瑞士

CARBOGEN AMCIS | Aarau

CARBOGEN AMCIS

开发和中等规模 cGMP 制造，包括色谱法。

发现我们的设施

Use: Human, Veterinary

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

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

Compliance: ISO, FDA (cGMP), PMDA/MHLW (Japan GMP), World Health Organization (GMP / HACCP)

Batch Size: Small, Medium

Category / Product: SERVICES, PARTICLE ENGINEERING, BIOLOGICS, CHEMICAL-SYNTHETIC

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

Region: Europe

瑞士

CARBOGEN AMCIS | Vionnaz

CARBOGEN AMCIS

高效 API 开发和小规模 cGMP 生产，包括色谱法和冻干法。

发现我们的设施

Services: Development services, Analytical / QC 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), CDSCO (India), TGA (Australia)

Compliance: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), EMA (EU GMP), World Health Organization (GMP / HACCP)

Use: Human, Veterinary

Batch Size: Small

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)

Region: Europe

Category / Product: CHEMICAL-SYNTHETIC

网络上有更多设施

注册即可解锁完整目录，其中包含联系方式和地点。

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创建免费帐户

在当前的制药和生物技术行业中，并非所有产品都需要——或能够支持——大规模生产。早期临床材料、孤儿药和个性化药物都要求具备灵活性、精确性和成本效益。因此，与经验丰富的小批量 CDMO 公司合作，对于以较低产量实现高效且符合 GMP 要求的生产至关重要。

通过量身定制的小批量合同生产解决方案，这些 CDMO 可帮助您应对早期开发、临床供应和细分市场商业化生产，同时最大限度减少浪费、缩短项目周期并确保全面的法规管控。

如何选择小批量 CDMO 公司

在评估小批量 CDMO 公司时，应考虑以下关键因素：

批量规模灵活性：能够处理从克级到千克级的物料以及不同批量体积
专用设备：适用于小规模生产，例如微型反应器、实验室级混合设备和一次性系统
速度与响应能力：能够快速推进和完成项目
隔离生产线：或用于高活性、无菌或个性化制剂的专用生产区域
临床试验用材料（CTM）生产经验
法规专业能力：支持 GMP 文件、QP 放行和全球申报
技术转移准备能力：可在需要时支持后续规模放大

灵活高效的 CDMO 应兼具技术质量与运营敏捷性。

小批量合同生产商提供的主要服务

领先的小批量合同生产服务商通常提供：

制剂开发：以及低产量产品的可行性评估
分析方法开发：以及稳定性试验
小规模混合、制粒、胶囊填充和压片
无菌灌装与完成：适用于小容量液体或冻干产品
个性化包装：适用于个体化治疗或低产量 SKU
批次文件：符合 GMP 和 ICH 标准
临床试验供应：包括生产和配送
支持罕见病、儿科和个性化医疗产品管线

这些服务非常适合希望在早期开发阶段或专业市场中降低风险并节约原料药用量的企业。

合作优势

与专业的小批量 CDMO 公司合作可带来以下主要优势：

更低的项目启动成本：适用于早期阶段和低产量产品
最大限度减少浪费：并提高原料药利用率
快速执行：缩短设备准备和项目交付周期
定制化项目管理：以及直接的技术支持
可扩展的生产路径：在需要时扩大至更大规模生产

这种模式非常适合优先考虑速度、灵活性和法规合规性，而非高产量生产的创新企业。