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    PremierPharma Ltd.

    CDMO
    United States
    https://premierpharmaltd.com

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    Drug Product
    Advanced Modalities
    Company Overview

    About

    PremierPharma Ltd. is a leading contract development and manufacturing organization headquartered in United States. We specialize in Small Molecule API Manufacturer, Analytical Testing, Biologics Manufacturer with state-of-the-art facilities serving clients globally.

    Key Expertise

    Biologics Drug Substance, Antibody-Drug Conjugates (ADC), Oral Solid Dose, Supply Chain Management, Fill/Finish (Syringes)

    Therapeutic Areas

    Immunology
    Rheumatology
    Quick Facts
    HQ:United States
    Founded:1987
    Employees:906
    Capabilities & Services

    Core Capabilities

    • Peptide Synthesis
    • Small Molecule API
    • Formulation Development

    Types of Organization

    Analytical & Bioanalytical Laboratory
    Commercial Manufacturing
    Drug Product Manufacturer (finished dosage, fill-finish, packaging)
    Formulation Development

    Dosage Forms

    Inhalation

    Containment Capabilities

    OEB 4 (1-10 µg/m³)

    Production Scales

    Phase III Clinical Trials
    Commercial Scale
    Clinical

    Batch Sizes

    1000L-5000L
    10L-100L

    Markets Served

    Global
    Manufacturing Facilities

    4 sites worldwide

    PremierPharma Ltd. - Headquarters

    776 Industrial Boulevard, San Francisco, San Francisco, 95104
    View on Map
    244,763 sq ft
    Established 2006

    Site Capabilities

    6 capabilities
    Fill/Finish (Cartridges)
    Cell & Gene Therapy
    Analytical Services
    Fill/Finish (Vials)
    Regulatory Support
    Fill/Finish (Syringes)

    PremierPharma Ltd. - Boston Facility

    823 Industrial Park, Boston, Boston, 69600
    View on Map
    122,550 sq ft
    Established 1997

    Site Capabilities

    3 capabilities
    Biologics Drug Product
    Small Molecule Drug Product
    Lyophilization

    PremierPharma Ltd. - San Diego Facility

    297 Science Way, San Diego, San Diego, 78139
    View on Map
    283,372 sq ft
    Established 2014

    Site Capabilities

    6 capabilities
    Oral Solid Dose
    Method Development & Validation
    Fill/Finish (Syringes)
    Fill/Finish (Cartridges)
    Cell & Gene Therapy
    Stability Studies

    PremierPharma Ltd. - North Carolina Facility

    186 Industrial Boulevard, North Carolina, North Carolina, 51644
    View on Map
    307,218 sq ft
    Established 2014

    Site Capabilities

    7 capabilities
    Supply Chain Management
    Small Molecule API
    Aseptic Processing
    Method Development & Validation
    Small Molecule Drug Product
    Lyophilization
    Regulatory Approvals
    Drug Approval PGIW8E
    FDA · #APR-GEVP2XOU · 2020-11-01
    Product Portfolio

    Advanced Formulation Service

    Brochure

    Our flagship service offering for Respiratory and Cardiovascular applications.

    Solution
    Ointment
    Delivery: Transdermal, IV Infusion

    Premium Formulation Service

    Brochure

    Our flagship service offering for Other and Respiratory applications.

    Tablet
    Cream
    Suspension
    Capsule
    Delivery: Oral, Intramuscular

    Standard Fill-Finish Service

    Brochure

    Our flagship service offering for CNS (Central Nervous System) applications.

    Ointment
    Suspension
    Capsule
    Injectable
    Delivery: Transdermal, Inhalation
    Certifications

    FDA Registration

    U.S. Food and Drug Administration
    Cert #: CERT-1VG6DEFI
    Issued: 2020-07-12
    Expires: 2025-02-15

    ISO 13485:2016

    International Organization for Standardization
    Cert #: CERT-HOK9Y574
    Issued: 2020-04-09
    Expires: 2025-04-27

    MHRA GMP

    UK Medicines and Healthcare products Regulatory Agency
    Cert #: CERT-ROYBFNBD
    Issued: 2020-02-01
    Expires: 2025-08-02
    Customer Reviews
    4.1

    Overall Rating(Based on 8 reviews)

    Project Management4.0
    Technology Transfer4.9
    On-Time Delivery4.1
    Communication Responsiveness3.9
    Innovation3.7
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    Key facts about PremierPharma Ltd.

    • PremierPharma Ltd. is headquartered in the United States.
    • PremierPharma Ltd. was founded in 1987.
    • PremierPharma Ltd. has 906 employees.
    • PremierPharma Ltd. has 4 manufacturing sites listed on CDMO Hub, in San Francisco, United States, Boston, United States, San Diego, United States and North Carolina, United States.
    • PremierPharma Ltd.'s capabilities include Peptide Synthesis, Small Molecule API and Formulation Development.

    Find CDMOs like PremierPharma Ltd.

    Directory pages this company appears in, each with the full list of matching manufacturers.

    CDMOs in United StatesCDMOs in North AmericaSmall Molecule API CDMOsFormulation Development CDMOsInhalation CDMOsOEB 4 (1-10 µg/m³) CDMOs
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