# Lyophilized & Freeze-Dried Injectables

*Lyophilized (freeze-dried) sterile powders for injection/infusion*

Anfarm's flagship manufacturing platform: freeze-dried (lyophilized) sterile powders for injection and infusion. Production capacity of 40 million vials per year across 10 freeze dryers and 4 dedicated production lines (1,400 m²), including lyophilization-cycle development and optimization for new molecules. The portfolio spans glycopeptide, lipopeptide, macrolide, glycylcycline and echinocandin anti-infectives, proton-pump inhibitors and other hospital injectables.

## Overview

- **Manufacturer:** Anfarm Hellas S.A.
- **Usage classification:** Prescription-only (Rx) sterile injectable pharmaceuticals for hospital use

## Key features

- Freeze-dried sterile powders reconstituted for injection or infusion
- Single-use glass vials in multiple strengths
- Hospital anti-infectives, antifungals and PPIs
- Developed and produced under EU GMP with ICH stability data

## Highlights & advantages

### Competitive Advantage

- 40 million vials/year lyophilized capacity: 10 freeze dryers, 4 dedicated production lines
- In-house lyophilization-cycle development and scale-up for new molecules
- EU GMP manufacturing with global marketing authorizations
- Available for out-licensing and third-party contract manufacturing

### Regulatory Certification

- EU GMP Manufacturing License (Greek Health Authorities)

### Clinical Indication

- Serious bacterial infections (glycopeptide, lipopeptide, macrolide, glycylcycline antibiotics)
- Invasive fungal infections (echinocandin & triazole antifungals)
- Acid-related gastrointestinal disorders (proton-pump inhibitors)
- Acute pain / inflammation (NSAID)
- Acromegaly & GI bleeding (somatostatin)

### Packaging Logistics

- Freeze-dried powder in single-dose glass vials
- Multiple strengths per molecule

## Specifications

| Specification | Value |
| --- | --- |
| Dosage form | Lyophilized (freeze-dried) powder for solution for injection/infusion |
| Production capacity | 40 million vials per year vials/year |
| Freeze dryers | 10 |
| Production lines | 4 dedicated lyophilized lines |
| Production area | 1,400 m² |

## Variants

- **Azithromycin** (Strength: 500 mg/vial; Dosage form: Pd.Sol.Inf (powder for solution for infusion); Therapeutic class: Macrolide antibiotic): Macrolide antibiotic, lyophilized powder for infusion
- **Caspofungin** (Strength: 50 mg & 70 mg/vial; Dosage form: Pd.C.So.In (powder for concentrate for solution for infusion); Therapeutic class: Echinocandin antifungal): Echinocandin antifungal
- **Clarithromycin** (Strength: 500 mg/vial; Dosage form: Pd.Sol.Inf; Therapeutic class: Macrolide antibiotic): Macrolide antibiotic
- **Dalbavancin** (Strength: 500 mg/vial; Dosage form: Pd.C.So.In; Therapeutic class: Lipoglycopeptide antibiotic): Long-acting lipoglycopeptide antibiotic
- **Daptomycin** (Strength: 350 mg & 500 mg/vial; Dosage form: Pd.I.S.Inf (powder for injectable solution/infusion); Therapeutic class: Lipopeptide antibiotic): Cyclic lipopeptide antibiotic
- **Esomeprazole** (Strength: 40 mg/vial; Dosage form: Pd.I.S.Inf; Therapeutic class: Proton-pump inhibitor): Proton-pump inhibitor
- **Omeprazole** (Strength: 40 mg/vial; Dosage form: Ps.Inj.Sol / Pd.Sol.Inf; Therapeutic class: Proton-pump inhibitor): Proton-pump inhibitor (injectable)
- **Pantoprazole** (Strength: 40 mg/vial; Dosage form: Pd.Inj.Sol; Therapeutic class: Proton-pump inhibitor): Proton-pump inhibitor (injectable)
- **Somatostatin** (Strength: 3 mg/vial; Dosage form: Ps.Sol.Inf (powder for solution for infusion); Therapeutic class: Somatostatin analogue / GI hormone): Growth-hormone-inhibiting hormone
- **Teicoplanin** (Strength: 200 mg & 400 mg/vial; Dosage form: Pd.Sol.Inf; Therapeutic class: Glycopeptide antibiotic): Glycopeptide antibiotic
- **Tenoxicam** (Strength: 20 mg/vial; Dosage form: Ps.Inj.Sol (powder for solution for injection); Therapeutic class: NSAID (oxicam)): NSAID (oxicam) for injection
- **Tigecycline** (Strength: 50 mg/vial; Dosage form: Pd.Sol.Inf; Therapeutic class: Glycylcycline antibiotic): Glycylcycline antibiotic
- **Vancomycin** (Strength: 500 mg & 1 g/vial; Dosage form: Pd.Sol.Inf (+ oral solution); Therapeutic class: Glycopeptide antibiotic): Glycopeptide antibiotic (also available as oral solution)
- **Voriconazole** (Strength: 200 mg/vial; Dosage form: Pd.Sol.Inf; Therapeutic class: Triazole antifungal): Triazole antifungal
- **Micafungin** (Status: Under registration / ready to file; Strength: 50 mg & 100 mg/vial; Dosage form: Pd.C.So.In; Therapeutic class: Echinocandin antifungal): Echinocandin antifungal (under registration)
- **Remifentanil** (Status: Under registration / ready to file; Strength: 1, 2 & 5 mg/vial; Dosage form: Pd.C.So.In; Therapeutic class: Opioid analgesic): Ultra-short-acting opioid analgesic (under registration)

## Frequently asked questions

### What is Anfarm's lyophilization capacity?

40 million vials per year across 10 freeze dryers and 4 dedicated production lines (1,400 m² production area).

### Are these products available for licensing or contract manufacturing?

Yes, Anfarm licenses out its lyophilized products and offers third-party contract manufacturing and technology-transfer services, including lyophilization-cycle development for new molecules.

## Documents

- [ANFARM Company Presentation](https://api.dev.mytradeloop.com/storage/10900~YRpe0P9pFAG1Cw3-) (company_profile, en, 30p)
- [ANFARM Product List Flyer](https://api.dev.mytradeloop.com/storage/10902~hTiHhVEVOvxQ5ILL) (brochure, en, 2p)
- [ANFARM International Product List](https://api.dev.mytradeloop.com/storage/10904~WVrEwtxrVWikYVkM) (catalog, en)

## Tags

40m-vials-year, 10-freeze-dryers, eu-gmp, lyophilized injectables, freeze dried powder for injection, sterile powder for infusion, generic antibiotics vials, contract lyophilization, vancomycin vial, caspofungin vial, daptomycin vial

> Made by [Anfarm Hellas S.A.](https://dev.mytradeloop.com/fr/companies/anfarm-hellas-s-a-9684). Contact the manufacturer via their profile page.

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