Leiters stands apart by focusing on one singular purpose:
bringing health to outsourcing.

Processes that ensure the highest quality 503B outsourced products.

  • Prior to commercialization, each new product completes a development process including independent laboratory confirmation of identity, potency, and sterility.
  • Use of fully validated product-specific sterile filtration during production to enhance Sterility Assurance Level (SAL).
  • Beyond Use Dates (BUDs) established based on product-specific stability testing of both chemical and microbiological characteristics.
  • Potency, bioburden, endotoxin and sterility testing by independent laboratory on 100% of lots produced.
  • Independent laboratory testing of chemical and microbiological characteristics including ID, bioburden, and endotoxin of all incoming powdered active and inactive ingredients.

Facility and Equipment that Ensure the Highest Quality 503B Outsourced Products.

  • Use of Germfree Vertical Laminar Flow Hoods which offer a high degree of localized control for critical processes, providing a sterile environment for the handling of materials and a work area continuously bathed in Class 100 HEPA-filtered air to protect the product from contamination.
  • Bioquell SeQure™, a fully validated automated biodecontamination system which uses vaporized hydrogen peroxide to eradicate the bioburden of microorganisms and other contaminants on all materials entering the aseptic core.
  • Negative-pressure isolators, fume hoods, biosafety cabinets for containment of powdered APIs during formulation.
  • Fully validated facility including extensive IQ, OQ, and EMPQ activities performed and/or reviewed by industry experts.
  • Validated building automation system to alert Quality, Production, and Facility personnel of cleanroom condition changes.

Processes that ensure the highest quality 503B outsourced products.

  • Prior to commercialization, each new product completes a development process including independent laboratory confirmation of identity, potency, and sterility.
  • Use of fully validated product-specific sterile filtration during production to enhance Sterility Assurance Level (SAL).
  • Beyond Use Dates (BUDs) established based on product-specific stability testing of both chemical and microbiological characteristics.
  • Potency, bioburden, endotoxin and sterility testing by independent laboratory on 100% of lots produced.
  • Independent laboratory testing of chemical and microbiological characteristics including ID, bioburden, and endotoxin of all incoming powdered active and inactive ingredients.

Facility and Equipment that Ensure the Highest Quality 503B Outsourced Products.

  • Use of Germfree Vertical Laminar Flow Hoods which offer a high degree of localized control for critical processes, providing a sterile environment for the handling of materials and a work area continuously bathed in Class 100 HEPA-filtered air to protect the product from contamination.
  • Bioquell SeQure™, a fully validated automated biodecontamination system which uses vaporized hydrogen peroxide to eradicate the bioburden of microorganisms and other contaminants on all materials entering the aseptic core.
  • Negative-pressure isolators, fume hoods, biosafety cabinets for containment of powdered APIs during formulation.
  • Fully validated facility including extensive IQ, OQ, and EMPQ activities performed and/or reviewed by industry experts.
  • Validated building automation system to alert Quality, Production, and Facility personnel of cleanroom condition changes.
Item Description Volume Container
Intravitreal Antibiotic Injections      
Cefuroxime Cefuroxime 10 mg/mL in 0.9% Sodium Chloride (Preservative-Free) 1 mL in a 2 mL Vial
Moxifloxacin Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) 1 mL in a 2 mL Vial
Other Ophthalmic Injections      
Avastin® (bevacizumab) (repackaged) Bevacizumab 2.5 mg/0.1 mL (25 mg/mL) repackaged injection 0.1 mL in a 1 mL Syringe
Lidocaine HCl / Phenylephrine HCl Lidocaine HCl 1% / Phenylephrine HCl 1.5% in sterile water for injection 1 mL in a 2 mL Vial
Topical Ophthalmic Solutions      
Atropine Sulfate Atropine Sulfate 1% in 0.9% Sodium Chloride (Preservative-Free) 4 mL in an 11 mL Dropper Bottle
Cyclopentolate HCl/ Tropicamide / Phenylephrine HCl Cyclopentolate HCl 1%/Tropicamide 1%/Phenylephrine HCl 2.5% in sterile water for injection 1 mL,5 mL,10 mL
Dropper Bottle
Edetate Disodium (EDTA) Edetate Disodium 3% in sterile water for injection 10 mL Dropper Bottle
Mitomycin Mitomycin 0.02% (0.2 mg/mL) in sterile water for injection 1 mL in a 2 mL Vial
Tropicamide/Phenylephrine HCI Tropicamide 1%/Phenylephrine HCI 2.5% in sterile water for injection 10 mL in a 15 mL Dropper Bottle
Avastin® is a registered trademark of Genentech, Inc.

Hospital Products

Intravenous Injections      
Item Description Volume Container
Glycopyrrolate      
  *Glycopyrrolate 0.2 mg/mL 5 mL Syringe
Lidocaine HCl      
  Lidocaine HCl 1% (10 mg/mL) 5 mL Syringe
  Lidocaine HCl 1% (10 mg/mL) Preservative-Free 5 mL Syringe
  Lidocaine HCl 2% (20 mg/mL) 5 mL Syringe
  Lidocaine HCl 2% (20 mg/mL) Preservative-Free 5 mL Syringe
Neostigmine Methylsulfate      
  *Neostigmine Methylsulfate 1 mg/mL 4 mL Syringe
  *Neostigmine Methylsulfate 1 mg/mL 5 mL Syringe
Phenylephrine HCl      
  Phenylephrine HCl 0.1 mg/mL in 0.9% Sodium Chloride 10 mL Syringe
Rocuronium Bromide      
  *Rocuronium Bromide 10 mg/mL 5 mL Syringe
  *Rocuronium Bromide 10 mg/mL 10 mL Syringe
Succinylcholine Chloride      
  *Succinylcholine Chloride 20mg/mL 5 mL Syringe
  *Succinylcholine Chloride 20mg/mL 7 mL Syringe
  *Succinylcholine Chloride 20mg/mL 10 mL Syringe
*products have an anticipated release date of 1st Quarter 2018