505(b)(2): It’s A Different Animal
Camargo
Service Sectors > Drug delivery, formulation
All service sectors
News headlines
- ADC Bio Expands Lab Services in Response to Demand
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- Recipharm to offer new metal-based delivery tech
- Derma Acquisitions and Need for Development Drive MedPharm Investment
- Demand Across Biopharma Drives Goodwin and Coldstream ADC Partnership
- Catalent Quadruples Biologics Services with Opening of New plant
- DSM Opens Australian Government Backed Biologics Facility
Products
Data sheet
505(b)(2): It’s A Different Animal - Camargo
13-May-2013 -
505(b)(2) is more than just a regulatory pathway, it is a distinctly different animal — a unique strategy that can often result in product approval with lower risk, reduced development cost and faster speed to market. Find out if 505(b)(2)...
On-Demand Supplier Webinar
Supply Chain Issues and Trends in Asia - Marken
02-May-2013 -
Import/export of biological samples from China
China: Large Pharma Reverse Logistics
A Common Issue: Destruction of Drug in Taiwan
J-GMP: How is GMP different in Japan?
Korea: Biosimilars Hotbed
India: Will Regulations Change to Allow Quicker Study Approval in 2013?
Case study
A risk assessment framework for donor and recipient companies to jointly analyze and document the technical and business risks associated with the technical transfer of pharmaceutical product - Alkermes
22-Apr-2013 -
Every technical (tech) transfer is different, with companies taking different paths toward reaching their goal. Each one presents a unique set of challenges. These challenges are most often technical, but at times they may also be business related. However all...
On-Demand Supplier Webinar
Industry Snapshot: Clinical Trial Trends Outline Complexity for Supply Chain - Marken
25-Mar-2013 -
2013 Industry trends driving the scientific, logistical and regulatory complexity of supply chain industry
Implement clinical development methodologies for quality, relationships, and performance
Strategies to optimize drug development to reduce global trial time and costs
Technical / white paper
What Makes 505(b)(2) Different? - Camargo
19-Mar-2013 -
When it comes to developing a compound, the 505(b)(2) drug development pathway is not just a regulatory platform — it’s a different animal. This pathway offers a holistic approach for developing products that offer differentiated benefits with Lower Risk, Reduced...
Research study
Vcaps® Plus capsules: The next generation HPMC capsule for optimum formulation of Pharmaceutical Dosage forms - Capsugel
28-Feb-2013 -
Traditionally, HPMC capsules have been formulated with secondary gelling agents and ionic gel promoters, which may lead to unwanted issues during the product development.Vcaps® Plus HPMC capsules are made through a proprietary manufacturing process that eliminates the need for gelling...
On-Demand Supplier Webinar
Optimizing your Strategy and Budget for Clinical Trial Supply Distribution - Marken
20-Feb-2013 -
How to determine if a depot or direct to site shipments are more efficient
Calculation based on a case study
How to avoid delays and assure that your shipments arrives without delays and excursions
Technical / white paper
Identifying the Product - Camargo
06-Feb-2013 -
When it comes to developing a compound, the 505(b)(2) pathway can make changes to reference products for greater profit potential and lower risk. Camargo Pharmaceutical Services offers a clear process from concept through commercialization to identify products with documented market differentiation:
Selection...
Case study
Blinding Techniques for Inhaler Devices - Development of a Novel Blinding Methodology for a Market Leading DPI - Almac Group
21-Jan-2013 -
Blinding inhalers for use in clinical studies is a challenging and specialised area of clinical trial supplies. In this case study, Almac provide a real life overview of their unique inhaler blinding services which have been successfully developed and validated,...
Technical / white paper
Best Practices for Achieving and Maintaining Aseptic Conditions During Sterility Testing - SGS
03-Dec-2012 -
Sterility testing is required for companies producing pharmaceutical products and consistent and meticulous testing is essential to obtain results that accurately represent the sterility status of a batch. Download this article for the best practices
Suppliers
Baxter BioPharma Solutions
Sterile Contract ManufacturingWith over 80 years of parenteral experience, BioPharma Solutions (a business unit of Baxter) offers a variety of contract manufacturing form/fill/finish services and solutions for injectables , designed to meet complex and traditional sterile manufacturing challenges. In addition, we are the only CMO to offer a manufacturer-prepared, commercial-scale aseptic filling process for premixed drugs in flexible IV bags.
Vetter Pharma International GmbH
Vetter is a leading contract development and manufacturing organization (CDMO) that specializes in the aseptic filling of syringes, cartridges and vials.
Capsugel
Capsugel is a global leader in innovative dosage forms and solutions for the healthcare industry. Offering a comprehensive array of products and services, from hard gelatin, liquid-filled, and vegetarian capsules, to innovative R&D equipment, Capsugel is at the forefront of drug delivery innovation providing support to customers from formulation to final production.
Recipharm AB
Recipharm AB is a leading contract development and manufacturing organisation (CDMO) based in Sweden employing some 1,700 employees.
Fresenius Kabi Product Partnering
Fresenius Kabi Product Partnering leads the way in contract development and manufacture of sterile pharmaceuticals and medical devices. As Fresenius Kabi’s business-to-business platform we are dedicated to contract manufacturing and offer our partners easy access to our worldwide development and manufacturing capabilities.
DPT Laboratories
With a specialized focus on semi-solids and liquids, DPT offers pharmaceutical companies the broadest range of capabilities in the industry. From R&D formulation to commercial-scale manufacturing, small batches to large, liquids to emulsions, sterile or non-sterile, we offer clients of all sizes the most effective resources for meeting challenges.
ROVI Contract Manufacturing
Contract manufacturing and pharmaceutical co-development through our 2 manufacturing plants located in Madrid, Spain. Both plants belong to Laboratorios Farmacéuticos ROVI: pharmaceutical company founded in 1946 and listed in the Madrid Stock Exchange Market since 2007. Revenues from 2011 were 184.7€ M and it takes count with over 840 employees.
Kemwell Biopharma Inc
Kemwell Biopharma is contract provider of CMC services to the pharmaceutical industry. With manufacturing locations in Bangalore India, and Uppsala Sweden, Kemwell offers services ranging from Clinical (CTM) Manufacturing, Commercial Manufacturing, Biopharmaceutical Manufacturing, Formulation Development, Analytical Development, Stability Testing & Packaging/Storage/Distribution.
Almac Group
Integrated Solutions from Research to Commercialisation. Almac is a financially secure, privately owned organisation with over 3,300 employees located within the US and UK. Over 600 companies worldwide, including all the market leaders, use our services, testament itself to the quality, innovation and efficiency of our business as proven over the past 30+ years.
Vetter Pharma International GmbH
Vetter is an independent international specialist in the production of aseptically pre-filled injection systems, cartridges and vials. For more than 25 years Vetter has been renowned for its quality, innovation and strategic partnerships.
