Silvergate Pharmaceuticals


Silvergate Pharmaceuticals is a U.S.-based specialty pharmaceutical company focused on development, manufacture and commercialization of age-appropriate oral dosage forms, including pediatric oral liquids and powder-for-reconstitution products. The company has received multiple FDA approvals for oral solution and powder formulations and operates programs for regulatory compliance, supplier relationships and pharmacy distribution.

Industries

biotechnology
health-care
life-science
medical

Nr. of Employees

small (1-50)

Silvergate Pharmaceuticals


Patents

Amlodipine formulations

US-12721843-B2

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Enalapril compositions

US-9968553-B1

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Enalapril compositions

US-9855214-B2

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Enalapril compositions

US-8778366-B2

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Enalapril compositions

US-8568747-B1

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Products

Lisinopril oral solution (pediatric)

An oral solution formulation of lisinopril developed and made available for pediatric patients; associated with an FDA approval for pediatric use.

Enalapril powder-for-reconstitution (pediatric)

A powder-for-reconstitution formulation of enalapril intended for pediatric hypertension; described in regulatory approval communications.

Methotrexate ready-to-use oral solution (oncology, pediatric)

A ready-to-use oral solution formulation of methotrexate made available for pediatric oncology use.


Services

Facilitation of medication access and distribution through pharmacy partnerships, including cross-border sourcing options.

Bringing approved oral solutions and powder products to market and supplying them to healthcare providers and pharmacies.

Expertise Areas

  • Pediatric formulation development
  • Oral liquid and powder-for-reconstitution dosage forms
  • Regulatory affairs and FDA approvals
  • CMC development and scale-up
  • Show More (2)

Key Technologies

  • Oral liquid formulation
  • Powder-for-reconstitution formulation
  • Ready-to-use oral solution preparation
  • Pediatric dosing/formulation methods
  • Show More (2)

News & Updates

FDA approval announced for a pediatric oral solution formulation of lisinopril.

Regulatory approvals announced for an enalapril powder-for-reconstitution oral solution and new pediatric indications.

Announcement of availability for a ready-to-use methotrexate oral solution formulation intended for pediatric oncology use.


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