AlpinePharma Pty Ltd

CDMO

Singapore

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Clinical Trial Supply & Logistics

Company Overview

About

AlpinePharma Pty Ltd is a leading contract development and manufacturing organization headquartered in Singapore. We specialize in Clinical Trial Materials, Small Molecule API Manufacturer with state-of-the-art facilities serving clients globally.

Key Expertise

Biologics Drug Product, Packaging & Labeling, Liquid/Semi-Solid, Viral Vectors, mRNA Production

Therapeutic Areas

Neurology

Quick Facts

HQ:Singapore

Founded:1993

Employees:683

Capabilities & Services

Core Capabilities

Cytotoxic / ADC Handling
High-Potency API
Sterile Fill/Finish

Types of Organization

Advanced Therapy Manufacturer (cell, gene, mRNA, ADC)

Biologics Manufacturer

Clinical Trial Supply & Logistics Provider

Commercial Manufacturing

Drug Product Manufacturer (finished dosage, fill-finish, packaging)

Dosage Forms

Topical / Transdermal

Containment Capabilities

OEB 5 (≤1 µg/m³)

Cytotoxic / ADC Handling

Production Scales

Pilot Scale

Phase I Clinical Trials

Clinical

Batch Sizes

1L-10L

5000L+

Markets Served

Asia-Pacific

Manufacturing Facilities

1 site worldwide

AlpinePharma Pty Ltd - Headquarters

868 Technology Way, Singapore, Singapore, 57506

View on Map

139,853 sq ft

Established 2000

Site Capabilities

6 capabilities

Formulation Development

Liquid/Semi-Solid

Microbiology Testing

Analytical Services

Cell & Gene Therapy

Sterile Injectable

Regulatory Approvals

Drug Approval UJG5BJ

EMA · #APR-HJ0TD9SZ · 2019-05-01

Drug Approval QZPQNW

EMA · #APR-DZMXAJFX · 2018-08-01

Product Portfolio

Standard Drug Product Service

Brochure

Our comprehensive service offering for Oncology and Infectious Disease applications.

Tablet

Lyophilized Powder

Delivery: Intramuscular, Topical

Advanced Fill-Finish Service

Brochure

Our specialized service offering for Cardiovascular and Oncology applications.

Tablet

Capsule

Injectable

Lyophilized Powder

Delivery: Intramuscular, Transdermal, Subcutaneous

Standard Drug Product Service

Brochure

Our comprehensive service offering for Ophthalmology applications.

Solution

Cream

Ointment

Delivery: IV Infusion, Topical, Oral

Standard Fill-Finish Service

Brochure

Our flagship service offering for Rare Disease and Dermatology applications.

Suspension

Cream

Injectable

Capsule

Delivery: Topical, Intramuscular, Subcutaneous

Case Studies

0 published case studies showcasing past projects, challenges and outcomes.

Certifications

FDA Registration

U.S. Food and Drug Administration

Cert #: CERT-FMNLQFAE

Issued: 2020-02-24

Expires: 2025-05-17

EMA GMP Certificate

European Medicines Agency

Cert #: CERT-F0MHPQ2Q

Issued: 2020-11-20

Expires: 2025-12-16

ISO 9001:2015

International Organization for Standardization

Cert #: CERT-ZZLJNYNT

Issued: 2020-04-28

Expires: 2025-05-07

Health Canada GMP

Health Canada

Cert #: CERT-BNEINHG8

Issued: 2020-12-20

Expires: 2025-10-11

Customer Reviews

4.0

Overall Rating(Based on 22 reviews)

Project Management4.2

Technology Transfer4.0

On-Time Delivery3.4

Communication Responsiveness3.8

Innovation4.5

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Key facts about AlpinePharma Pty Ltd

AlpinePharma Pty Ltd is headquartered in Singapore.
AlpinePharma Pty Ltd was founded in 1993.
AlpinePharma Pty Ltd has 683 employees.
AlpinePharma Pty Ltd has one manufacturing site listed on CDMO Hub, in Singapore, Singapore.
AlpinePharma Pty Ltd's capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.

Find CDMOs like AlpinePharma Pty Ltd

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

Fill-Finish CDMOs Topical / Transdermal CDMOs OEB 5 (≤1 µg/m³) CDMOs Cytotoxic / ADC Handling CDMOs

Key facts about AlpinePharma Pty Ltd

AlpinePharma Pty Ltd is headquartered in Singapore.

AlpinePharma Pty Ltd was founded in 1993.

AlpinePharma Pty Ltd has 683 employees.

AlpinePharma Pty Ltd has one manufacturing site listed on CDMO Hub, in Singapore, Singapore.

AlpinePharma Pty Ltd's capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.