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Ophtapharm, a Sentiss Company
Switzerland

Ophtapharm, a Sentiss Company

Ophtapharm, a Sentiss Company

Ophtalmic and Otic - Solutions, suspensions, emulsions, ointments and gels - FDA Approved facility.

MARKETS: EMA (EU), FDA (USA)

REGION: Europe

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

BATCH SIZE: Large, Small, Medium

USE: Human, Veterinary

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

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

Cenexi Hérouville Saint Clair
France

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

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SERVICES manufacturing site

MAI network supplier

EU-GMP-certified CMO based in Martin, Slovakia. The company provides manufacturing and packaging servicesfor sterile pharm. products and solid oral dosage forms

Location available after registration

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COSMETICS manufacturing site

MAI network supplier

One-stop CDMO Solutions for APl and Key intermediates.

Location available after registration

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FDF / DRUG PRODUCTS manufacturing site

MAI network supplier

CMO combining advanced facilities, stringent QC, and expert staff to deliver reliable, compliant, and innovative solutions.

Location available after registration

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FDF / DRUG PRODUCTS manufacturing site

MAI network supplier

CDM Lavoisier is specialized in the manufacturing of glass ampoules, glass vials and plastic (BFS) ampoules.

Location available after registration

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FDF / DRUG PRODUCTS manufacturing site

MAI network supplier

We can take your pharmaceuticals from lab scale to the early clinical phase and beyond.

Location available after registration

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FDF / DRUG PRODUCTS manufacturing site

MAI network supplier

A GMP facility fully equipped for R&D and pharmaceutical development. Includes laboratories and a pilot plant for technical and clinical batches.

Location available after registration

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FDF / DRUG PRODUCTS manufacturing site

MAI network supplier

Reliable CDMO partner for aseptic manufacturing and lyophilization of biologics and injectable drugs.

Location available after registration

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COSMETICS manufacturing site

MAI network supplier

Production facility that complies with the latest GMP standards for sterile and aseptic liquids, particularly glass ampoules.

Location available after registration

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SERVICES manufacturing site

MAI network supplier

CDMO specializing in sterile unit-dose liquid drug products using Blow-Fill-Seal (BFS) technology.

Location available after registration

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SERVICES manufacturing site

MAI network supplier

The site specializes in the development and production of solid and liquid pharmaceutical forms, both sterile and non-sterile.

Location available after registration

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