Capabilities/Organization

Capabilities and Organization

Sales

Legacy Pharmaceuticals International currently sells finished pharmaceutical products to more than 70 countries globally. We serve the following regions either directly or through distribution partners and its customers:

EU/ Eastern Europe
Middle East
Americas
Asia Pacific including China and Japan
Africa
Australasia/Oceania

Marketing and sales activities are handled in Birsfelden where our Customer Service Department interacts on a daily basis with customers world-wide. Legacy has selected partners throughout the world which have their own sales forces, regulatory affairs and/or distribution channels.

Markets

Key Legacy staff have been working at the site for over 20 years and have experience with over 70 countries worldwide. This includes most countries in all major regions of the world:

1. Europe
    -  EU
    -  Non-EU

2. Asia
    -  CIS and Mongolia
    -  Southeast
    -  Middle East

3. Americas
    -  U.S. and Canada
    -  Caribbean
    -  Central
    -  South

4. Africa

5. Oceania

Legacy meets the needs of customers and partners operating the world over. Legacy is able to supply the right documentation on time for regulatory affairs (registration and ongoing), order handling, shipping and payment for the goods.

Regulatory Affairs

Legacy's Swiss operations handle regulatory affairs in two ways for Legacy's Swiss operations. Within Switzerland we work with competent external agencies that carry out the necessary liaison between our factory or third party suppliers and our customers and partners. In other markets, Legacy has chosen partners who are familiar with the local regulatory needs and which deal on a day to day basis with the local regulatory authorities. Legacy's US operations work with an external agency for drug regulatory and CMC updates.

Legacy's manufacturing sites have been inspected and/or are approved by the following agencies:

Birsfelden, Switzerland

Swissmedic (production, import, export & distribution of pharmaceuticals including narcotics)
Saudi Arabian Health Authorities
The European Drugs Agency
Ministry of Health, Labor and Welfare (Japan)
The State Food and Drug Administration of the Peoples Republic of China
The Taiwan International Health Action
ILSI Argentina
World Health Organisation

Humacao, Puerto Rico

FDA (US)
ANVISA (Brazil)
German Health Agency (German, for the EU)
DEA (US)

Logistics

Legacy's Logistics Departments in Switzerland and Puerto Rico perform all customer-facing functions necessary for the sale and distribution of pharmaceuticals worldwide. These functions include:

Compilation of demand forecasts submitted by customers and partners
Processing of sales orders
Invoicing
Export documentation
Booking of freight services
Collection of receivables

Warehousing

Legacy has substantial warehouse space to support its manufacturing and distribution activities:

Switzerland: 6000 pallets
Puerto Rico: 5000 pallets

Manufacturing - Locations and Capacities

Puerto Rico Manufacturing Capabilities

Legacy Pharmaceuticals Puerto Rico LLC
Bo. Mariana Rd 909, Km 1.1
HC-01, Box 16625
Humacao, Puerto Rico 00791
Tel: 1-787-656-0909

Switzerland Manufacturing Capabilities

Legacy Pharmaceuticals Switzerland GmbH

Rührbergstrasse 21

CH-4127 Birsfelden

Switzerland

Tel: +41-61-316-1600

Drug Regulatory

Legacy has robust capabilities and extensive experience for drug regulatory work. Our business units each have more than 30 years experience in this area and maintain internal and external capabilities.

Medical Support and Pharmacovigilance

Legacy has robust capabilities and extensive experience for medical support and pharmacovigilance. Our business units each have more than 30 years experience in this area and maintain internal and external capabilities.

Chemistry, Manufacturing and Controls,
Quality Assurance and Quality Control

Legacy's Quality Operations are managed globally by Francisco Gutierrez, Vice President of Quality Management. Legacy manufacturing sites each have robust QA and QC departments staffed with highly qualified personnel.

In addition to performance of daily QA and QC duties, these teams also manage the technical documentation necessary for regulatory submissions and updates.

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