CPL

Contract Development and Manufacturing of Non-Sterile Liquid and Semi-Solid Products

CPL is a leading contract developer and manufacturer (CDMO) of non-sterile liquid and semi-solid pharmaceutical products.

CPL is a leading contract developer and manufacturer (CDMO) of non-sterile liquid and semi-solid pharmaceutical products. CPL is uniquely focused on the development, manufacturing, packaging and testing of creams, ointments, gels, lotions, and non-sterile solutions, suspensions, and nasal sprays.

With a strong record of regulatory compliance, exceptional customer service, and product expertise, CPL is the trusted choice for your pharmaceutical outsourcing projects. By offering turnkey services, from development to commercial production, CPL creates strategic relationships with customers that result in long-term successes.

We have been in business for more than 23 years and have grown to become a leading CDMO for non-sterile liquid and semi-solid products for large, mid-size, and specialty branded and generic pharmaceutical customers in North America, Europe, and Asia Pacific.

Topical semi-solid and non-sterile liquid formulation and product development

Our team understands the unique challenges of developing liquid and semi-solid pharmaceutical products. Our product development services (PDS) team of 22 dedicated experts has a combined 90 years of formulation experience, with 75 years of analytical experience and has worked on a full spectrum of products.

Our services include development of new formulations, formulation and process optimisation, analytical method development, clinical trial supplies manufacturing, and commercial scale-up. Our team has developed many NDA, ANDA, 505(b)2, and OTC products within these dosage forms. PDS has state-of-the-art pre-formulation, formulation, and analytical testing equipment and labs located in our manufacturing facility, including a pilot manufacturing suite for scale-up and clinical trial material projects.

Commercial manufacturing and packaging services

CPL's GMP commercial operations are focused on the manufacturing and packaging of non-sterile liquid (suspensions, solutions, nasal sprays) and semi-solid (gels, lotions, creams, ointments) pharmaceutical products. A dedicated technology transfer team supports our customers with new product launches or the transfers of existing products into our commercial manufacturing operation.

CPL has a wide variety of mixing vessels and tanks from 20kg pilot scale to 5,000kg commercial scale that support a variety of product types, viscosities, and processes. Our packaging capabilities include metal and laminate tubes, plastic and glass bottles and jars (including metered dose pumps), nasal spray devices, and foil sachets. Our packaging also includes secondary packaging into unit cartons, labelling, and shrink-wrapping.

Analytical R&D, pharma product stability and testing services

As a full-service CDMO, CPL has a GMP analytical testing lab that supports product development and commercial manufacturing operations. Our GMP analytical lab provides R&D services such as method development and validation, cleaning validation, method transfers and special studies. It conducts all routine product testing such as raw materials, bulk and finished products, and microbiological testing in its internal micro lab. The lab is equipped with a large number of walk-in and portable stability chambers with ICH and custom conditions that are remotely monitored and connected to back-up generators.

Speciality pharmaceutical products manufacturing

Our manufacturing suite segregation and engineering controls allow for the handling and processing of many specialized products including high-alcohol containing or flammable materials, light or oxygen sensitivity, some potent compounds, corticosteroids and hormones. Our packaging lines support the filling of these products through use of nitrogen blanketing or dedicated areas for explosion-proof filling.

FDA and Health Canada registered facilities

CPL has two facilities, a manufacturing site in Mississauga and its testing lab in Markham, Ontario. Both are registered with the US FDA and Health Canada. Both sites have been routinely audited by these agencies and our customers. CPL's facilities have self-identified as generic manufacturing and testing sites under the US GDUFA law and are in current standing as such.

Contact Details

CPL (Contract Pharmaceuticals, Ltd)
7600 Danbro Crescent
Mississauga
L5N 6L6
Ontario
Canada
Contact: For new business inquiries in Eastern US and Canada, please contact David Tyler
David Tyler: +1 716 683 3740
Karen Hanley: +1 415 384 8537
DTyler@cplltd.com
khanley@cplltd.com
www.cplltd.com

Available White Papers

Download

Determination of Absorption of Isopropyl Myristate in Processing Equipment and Packaging Material by Liquid Extraction and Gas Chromatography 19 January 2017 Isopropyl myristate (IPM) is widely used as a penetration enhancer and emollient in topical formulations.

Download

Quantitative Determination of Multiple Ingredients in Topical Formulation by Gas Chromatography 07 January 2015 Gas chromatography (GC) is a typical chromatographic method used to separate and quantitatively determine analytes that can be volatised without decomposition.

Download

CPL: Product Development through Commercialisation 01 October 2014 CPL develops and manufactures non-sterile liquid and semi-solid pharmaceutical products. We are solely focused on these dosage forms and have built our reputation as an industry-leading contract development and manufacturing organisation (CDMO).