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Penn Pharma

Drug Development, Clinical Supplies & Contract Manufacturing Solutions

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Penn Pharma

Penn Pharma is a leading provider of fully integrated and cost effective pharmaceutical development, clinical supply and manufacturing and packing services to the international healthcare industry, whose services support a fast and effective route from clinic to market. Penn provides unparalleled service offerings developed over its 30 year trading history.

Penn Pharma is committed to improving the health and quality of life for patients around the world through its support of the development of new medicines and devices.

Our aim is to provide solutions and challenge in a consultative way to identify and predict hurdles before they are reached, to help our customers succeed. To achieve this we demonstrate passion, energy and commitment to our task which facilitates speed of customers’ products to market. Outstanding customer care is Penn Pharma’s primary goal and we continually strive for excellence in all our processes.

Pharmaceutical development and drug product manufacturing services

Penn Pharma provides pharmaceutical development and drug product manufacturing services to the European and international health care industry. Penn Pharma’s services support a fast and effective route from early human clinical trials through later phases to commercialisation of medicinal products. Our customers range from virtual pharmaceutical companies, who own intellectual property (IP) but have no operational capabilities through small and medium pharma and contract research organisations (CRO’s) to the top 50 pharmaceutical companies.

We believe our service offerings are unparalleled, because Penn Pharma has 5 core competencies which support both clinical and commercial product development and supply. Here, clinical is defined as drugs in phases I through phase lll human clinical trials and commercial is defined as phase lV post approval, unlicensed medicines (Specials) and products holding Marketing Authorisations (MAs).

Pharmaceutical service solutions

From its fully integrated operations in South Wales, UK, Penn’s core services include:

  • Formulation development
  • Analytical services
  • Clinical Trial Supply – Phase I – IV packing and labelling, including FastTrack™
  • Clinical Trial Manufacturing including highly potent molecules
  • Logistics – storage, distribution, returns, destruction and inventory management of clinical and commercial materials including support management of Investigator Sponsored Studies
  • Specialised manufacturing, from pilot to commercial batch sizes
  • Manufacture of specials (unlicensed medicines)
  • Qualified person (QP) release services
  • Importation of clinical and commercial products into EU through our PharmacEUtical Portal™ service

MHRA regulated and FDA inspected facility

Our fully integrated GMP compliant facilities meet the highest quality and regulatory standards, are licensed by the MHRA and are regularly inspected by the FDA. Penn Pharma is also licensed by the UK Home Office for importation and storage of controlled drugs.

Penn has numerous industry recognised awards including two Queen’s Awards for Enterprise in recognition of the quality service we provide to the international healthcare industry.

Penn Pharmaceutical Services Ltd
23-24 Tafarnaubach Industrial Estate
Tredegar
Gwent, South Wales
NP22 3AA
United Kingdom

Tel: +44 (0) 1495 711 222
Fax: +44 (0) 1495 711 225
enquiries@pennpharm.com
www.pennpharm.com

Analytical Services

Working to ICH and cGMP guidelines, we provide analytical support for a wide variety of product development programmes. With an extensive range of fully qualified analytical equipment available as well as comprehensive stability studies expertise, we work closely with our clients to assist at every stage of the product development cycle.

With a track record of successful MHRA and FDA audits we offer clients complete piece of mind by providing analytical support for a wide variety of product development programmes. Our clients ranges from small companies with specific development needs to multi-nationals requiring turnkey stability programs for commercial batches.Penn also provides testing of product upon importation…

Clinical Trial Supplies: Manufacturing, Packing and Labelling, Including FastTrack™

We offer expert, cost effective, flexible and reliable support for your clinical supplies from Phase I to Phase IV through in depth project management resources to ensure timelines are met.

Primary and secondary packingBlinding and randomisationMulti territory label generation"Just-in-time" packingCost effective inventory management of high value productsFrom open to randomised supplies and working closely with our manufacturing and storage and distribution teams we manage labelling, packing and compliance of your clinical trial supplies. We deliver practical solutions resulting in improved compliance of patient packs which…

Commercial Manufacturing and Packing

Penn Pharma specialises in the manufacture and packing of commercial batches of solid oral dose, topical and oral liquids. Our highly flexible manufacturing services are particularly suitable for low-demand products, including orphan medicines and veterinary products.

To complement our development services, we offer efficient and high-quality cGMP contract manufacturing and packing of a wide range of pharmaceuticals and devices. We provide validation and scale up of manufacturing processes and our vast experience enables us to offer bespoke packing and distribution services.Having successfully undergone several FDA audits, our clients are ensured of…

Formulation Development

We work on new active substances, generics and the reformulation of existing products to meet current requirements. Specialist expertise in formulating solid oral dose, topical & oral liquid dosage forms.

Penn's highly qualified Formulation Development team has vast experience of practical pharmaceutical formulation. With a track record in successfully developing products for international clients, you can be assured of an innovative technical service to develop your optimised formulation. Working closely with other departments, this optimisation includes rapid preformulation studies to support new drug candidates to…

Logistics

Penn provides exemplary storage and distribution services from its UK operational warehouses and team of logistic experts in conjunction with its worldwide distribution network.

At a glance:Multiple licensed temperature controlled UK-based storage facilitiesWorld-wide audited & managed distribution networkElectronic inventory management system with customer portalExpertise in controlled temperature supply chain managementAll operations fully compliant to MHRA and FDA audited standardsUplifting of used, unused and surplus investigational medicinal product from investigator sites and return to Penn for processing, storage or destructionManagement…

QP Services

With a strong team of QPs, Penn supports clinical and commercial pharmaceutical projects, including assistance to companies wishing to import medicinal products and devices into the EU.

At Penn we believe flexibility is imperative. That's why you can choose to use our highly effective QP service in support of all our development services or as a 'stand-alone' consultancy. This has been particularly useful for our customers located in Japan, USA and Australasia, including assistance to API manufacturers and purchasers needing to meet…
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