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Patheon

API Commercial Product Supply

Dosage Forms

Every pharmaceutical product presents unique manufacturing challenges, just as every pharmaceutical company has its own business requirements. The more options that are available, the more precisely you will be able to meet these needs. This is why Patheon offers such an expansive range of choices in dosage forms and technologies.

However, often those needs extend beyond the actual dose to other aspects of commercial supply. With Patheon you’ll have the option of integrating packaging, regulatory and logistical support, as well as drug substance process development and manufacturing, with the production of your finished dosage form. Instantly simplify your supply chain with a single, highly capable strategic partner.



Oral Solids

Bring more than 40 years of experience to your project. Access a remarkable range of conventional and specialized oral solid dosage form capabilities. Further expand your options with innovative combinations of these forms and a variety of controlled-release technologies. All these choices are executed with the expansive scientific resources and expertise to rapidly establish a reliable commercial supply for even the most difficult to manufacture pharmaceuticals, including those made with highly potent compounds and controlled substances.

Whether you are establishing a commercial supply for a new product, transferring an existing product, have a life cycle management project for an established drug, or seeking opportunities and resources in the fast-paced over-the-counter market, with Patheon you’ll have access to all the oral solid dosage capabilities, capacity and quality you need to achieve your goals.


Conventional

  • Immediate-release tablets
  • Powder-filled capsules
  • Powders, granules and coated beads

Specialized

  • Liquid-filled capsules
  • Controlled-release tablets
  • Multilayer tablets
  • Fast-dispersible tablets

Softgels

Attractive and easy to swallow, most patients prefer softgels. This has made them a very popular dosage form for prescription and over-the-counter products as well as a life cycle management strategy. Patheon offers a broad range of options.

  • Softgel Capsules
  • Twist-Off Softgels
  • EnteriCare® Softgels
  • LiquiSoft Softgels
  • Versatrol Softgels
  • Solvatrol Softgels
  • Soflet® Gelcaps
  • Chewels® Chewable Gels

With Patheon, you’ll have access to much more than reliable high-quality contract manufacturing. You’ll have access to capabilities spanning every stage of a pharmaceutical’s development and commercial life cycle. This includes the formulation expertise to maximize the many technical advantages of softgels.

  • Precise control of drug release rate and site of absorption
  • Specialized technologies for enhanced solubility
  • Lower dose levels with higher bioavailability
  • Faster drug action and reduced food effect
  • Hermetic seal for oxygen-sensitive APIs
  • Masking of unpleasant tastes and odors
  • Opacity range from clear to opaque for light-sensitive APIs
  • Liquid, suspension, semi-solid and solid fill materials of any viscosity
  • Alkali or acidic gelatin shells formulated for each fill material
  • Reduced exposure risks for high potency compounds
  • Broad palette of shapes, sizes and colors
  • Options for chewable and topical applications

Softgels are easily scaled for changing commercial supply demands. That’s because small and large batches are made with the same process and on the same equipment.


Steriles

Access extensive sterile pharmaceutical manufacturing capabilities and scales, including terminal sterilization, aseptic processes and world-class expertise in lyophilization. With Patheon you’ll also have access to state-of-the-art commercial-scale cGMP manufacturing for prefilled syringes and cartridges.

  • Liquid Small Volume Parenterals (SVP): Choose from a wide range of vial forms and sizes to achieve exactly the right solution for your project.
  • Liquid Large Volume Parenterals (LVP): Available in a broad array of  sizes, we often utilize this dosage form to help clients efficiently achieve proof of concept.
  • Lyophilized Vials: Benefit from the speed and efficiency of seamless scale-up from development to commercial manufacturing. This is possible because the equipment at our European and North American facilities range from 2 mm vials to 100 mm vials. This enables precise control of your process conditions at every phase and scale.
  • Prefilled Syringes & Cartridges: Ready-to-use dosage formats that enable self administration of parenterals which once required a clinical visit. As the healthcare industry seeks to move treatments into the home, Patheon is investing in capabilities that will keep you ahead in the evolving marketplace.

Our sterile capabilities also include process development and manufacture of biologic drug substances at all scales from clinical to global commercial. With Patheon as your single-source partner, you’ll be able to bring your discoveries to market with more speed and efficiency than ever before.


Process Validation and Tech Transfer

Complete process validation in accordance with regulatory and cGMP guidelines is essential to the establishment of a reliable high-quality commercial supply.

  • Process validation with critical parameters
  • Validation of analytical assays
  • Hold time studies
  • Stability studies in required ICH conditions
  • Container shipment studies
  • Release testing
  • CMC documentation in CTD format

While technology transfers are commonly viewed as part of the normal course of business, at Patheon we see them as an opportunity to use our integration and efficiency to give clients a strategic and financial advantage. Even when your transfer is urgent, Patheon can execute it quickly and effectively to minimize interruption to product supply.

In 2016, Patheon successfully completed the Technology Transfer of 111 commercial scale products. In all cases, we are driven by your deadlines, flexible in our approach and determined to get your tech transfer right the first time every time. It is with this approach we won the European Outsourcing Award for Most Effective Technical Transfer in 2008, 2010, 2011 and 2012.


Analytical Services

Repeatable high quality delivered by exceptional analytical services teams. The speed and efficiency of being in-house at every manufacturing facility. Fully equipped cGMP labs providing you with comprehensive project support. Access to a comprehensive, state-of-the-art stability testing facility featuring the latest automated systems, and DEA-compliant areas for controlled substances. Work with Patheon and you’ll always have access to the full breadth of our analytical services and capabilities.

  • In-process control production support
  • Release testing
  • Stability testing for various ICH climatic zones
  • PAR studies
  • IND/IMPD dossier support

Benefit from know-how grounded in the experience of manufacturing hundreds of products, and scientifically sound data for your regulatory submissions. You’ll feel confident in the high quality of your product and processes because of the high quality of the analytical data they’ll be built upon. No matter what the demands of your project.


Commercial Batch Manufacturing

Patheon is a global leader in contract pharmaceutical manufacturing. You’ll have access to extensive commercial capabilities, scale and capacity; the full spectrum of oral solid and sterile dosage forms; and a global network of fully integrated world-class facilities – all with approvals from international regulatory agencies and Right First Time/On-Time track records that are second to none. With Patheon you’ll have a partner whose groundbreaking custom manufacturing suites and streamlined supply chain solutions are transforming how pharmaceuticals are made. Over 40 years, quality and innovation have earned Patheon the trust of the industry:

  • All of the top 20 pharmaceutical companies*
  • 15 of the top 20 specialty pharmaceutical companies*
  • 18 of the top 20 biotech companies*

In 2015 we produced more than 700 products for delivery to more than 70 countries. This includes the development or manufacturing of 27 of the top 100 pharmaceutical Rx products of 2015.

Source: Development and commercial client list 2015; EvaluatePharma ® WW Prescription (Rx) 2015 sales data.


Packaging

High-capacity cGMP primary and secondary packaging for oral solid and sterile dosage forms for both long-term and short-term needs. Patheon can deliver a finished product approved for distribution around the world, and do so for multiple markets from a single batch. Plus you'll have access to expert guidance in stability, safety and USP testing, as well as component specification. Patheon is a flexible and efficient alternative to specialized vendors. With the same level of expertise and quality, you can directly align your packaging with your product manufacturing to streamline your supply chain. Generate even more efficiency and speed to market by also tying in the development and manufacture of your drug substance.


Custom Manufacturing Suites

Patheon is dedicated to providing clients with solutions precisely tailored to meet the unique requirements of their product and business. That may mean collaborating with you on the design, construction, management and operation of a fully equipped, state-of-the-art, cGMP manufacturing suite within one of our facilities. Benefit from our expertise in facility design, construction, equipment selection, process development and technical transfers to ensure you have the commercial product supply you need to succeed.