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Hikal Ltd | Bangalore, India
India

Hikal Ltd | Bangalore, India

Hikal Ltd.

cGMP Process Development, Scale-up and Manufacturing of Small Molecule APIs, NMEs and Intermediates from grams to tones.

MARKETS: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), Rest of World, ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), 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, (C) Cardiovascular system, (D) Dermatologicals, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (V06) Nutrients

COMPLIANCE: EMA (EU GMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), FDA (cGMP), ECOVADIS, ISO, Halal Research Council, COFEPRIS

CATEGORY / PRODUCT: COSMETICS, SERVICES, NUTRACEUTICALS, CHEMICAL-SYNTHETIC

USE: Human, Veterinary

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)

SERVICES: Manufacturing services, Development services

Adragos Pharma | Kawagoe
Japan

Adragos Pharma | Kawagoe

Adragos Pharma

Our facility provides best-in-class manufacturing of tablets and ampoules.

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES

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

COMPLIANCE: EMA (EU GMP), PMDA/MHLW (Japan GMP), FDA (cGMP)

BATCH SIZE: Large

CONTROLLED SUBSTANCES: Lowest potential for abuse, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse

USE: Human

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

REGION: APAC

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)

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PARTICLE ENGINEERING manufacturing site

MAI network supplier

An API and Interemediate manufacturer having global certifications.

Location available after registration

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SERVICES manufacturing site

MAI network supplier

GMP-compliant biologics manufacturing facility specializing in recombinant enzymes and proteins.

Location available after registration

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COSMETICS manufacturing site

MAI network supplier

Small molecule drug substance development and manufacturing site.

Location available after registration

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COSMETICS manufacturing site

MAI network supplier

Small molecule drug substance development and manufacturing site.

Location available after registration

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CHEMICAL-SYNTHETIC manufacturing site

MAI network supplier

Synfine Drugs Private Limited, based in Hyderabad, India, stands as an innovative and forward-thinking pharmaceutical firm.

Location available after registration

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FDF / DRUG PRODUCTS manufacturing site

MAI network supplier

An USFDA approved API & Intermediate Manufacturing facility.

Location available after registration

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SERVICES manufacturing site

MAI network supplier

Su socio CRO/CDMO de confianza

Location available after registration

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SERVICES manufacturing site

MAI network supplier

Location available after registration

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CHEMICAL-SYNTHETIC manufacturing site

MAI network supplier

Pharmaceutical organization engaged in delivering advanced Discovery, Contract Development, and Manufacturing (CDMO) solutions.

Location available after registration

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BIOLOGICS manufacturing site

MAI network supplier

Kemwell Biopharma is a biologics focused CDMO company providing services to global biopharmaceutical organisations.

Location available after registration

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