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Glatt Pharmaceutical Services GmbH Co. & KG
Germany

Glatt Pharmaceutical Services GmbH Co. & KG

Glatt Pharmaceutical Services GmbH Co. & KG

Your cGMP-compliant CDMO for end-to-end services in the complex oral solids dosage forms field, based in Binzen Germany.

BATCH SIZE: Small, Medium, Large

THERAPEUTIC AREAS OF EXPERTISE (ATC): (R) Respiratory system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (S) Sensory organs, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (N) Nervous system, (B) Blood and blood forming organs, (V06) Nutrients

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, OLIGONUCLEOTIDES, PARTICLE ENGINEERING, CHEMICAL-SYNTHETIC

COMPLIANCE: EMA (EU GMP), FDA (cGMP)

CONTROLLED SUBSTANCES: Lowest potential for abuse, High potential for abuse & no medical use, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse

REGION: Europe

USE: Human, Veterinary

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

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

MARKETS: FDA (USA), EMA (EU)

BSL (Biological Safety Level): 1

Aenova Group - Location Bad Aibling, Germany
Germany

Aenova Group - Location Bad Aibling, Germany

Aenova

Centro de competencia Envasado en blíster Envasado para terceros Planta de gran volumen para efervescentes.

BATCH SIZE: Small, Medium, Large

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, COSMETICS, SERVICES, NUTRACEUTICALS, CHEMICAL-SYNTHETIC

COMPLIANCE: EMA (EU GMP), IFS, FDA (cGMP), ISO

REGION: Europe

USE: Human, Veterinary

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

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

MARKETS: FDA (USA), EMA (EU)

Laboratorio REIG JOFRE, SA (TOLEDO PLANTS)
Spain

Laboratorio REIG JOFRE, SA (TOLEDO PLANTS)

LABORATORIO REIG JOFRE SA

Betalactam antibiotics (FDF) development and manufacturing state-of-the-art facilities.

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

BATCH SIZE: Medium, Large

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC

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

CONTROLLED SUBSTANCES: Lowest potential for abuse

REGION: Europe

USE: Human, Veterinary

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

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

BSL (Biological Safety Level): 1

THERAPEUTIC AREAS OF EXPERTISE (ATC): (J) Antiinfectives for systemic use

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FDF / DRUG PRODUCTS manufacturing site

MAI network supplier

Tu CDMO de confianza con certificación GMP, especializada en fabricación farmacéutica estéril y no estéril, desarrollo de formulaciones y análisis avanzados.

Location available after registration

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FDF / DRUG PRODUCTS manufacturing site

MAI network supplier

Boronia, Victoria (VIC), Australia

Location available after registration

Limited view

FDF / DRUG PRODUCTS manufacturing site

MAI network supplier

Servicios de investigación y desarrollo, servicios analíticos, transferencia tecnológica e introducción de nuevos productos, y servicios de fabricación en el ámbito de las formas farmacéuticas…

Location available after registration

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Are you a pharmaceutical company seeking a reliable CMO or CDMO partner to accelerate your drug development process? Look no further than MAI CDMO Network. Our advanced search platform connects you with a vast network of qualified contract manufacturers and development organizations worldwide.

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