505(b)(2): It’s A Different Animal
Camargo
Service Sectors > Fill & finish, packaging
All service sectors
News headlines
- Demand Across Biopharma Drives Goodwin and Coldstream ADC Partnership
- ATMI Adds New Single-Use Fill/Finish Tech in Deal with CMO D-Lab
- CoreRx Plans $2M Expansion of Florida Solids Manufacturing Facility
- India Pushes Back Deadline for Barcodes on Primary Drug Packages Again
- Quay adds Dedicated Ph III Packing and Distribution Capacity
- Hospira Recalls Lots of Five Injections as FDA Re-Inspection Continues
- FDA approves packaging plant as Almac welcomes US clients
Products
Live 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
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,...
Case study
Alkermes successful approach to commercial-scale, final dosage manufacture of drug product containing highly potent API for a global pharmaceutical company. - Alkermes
18-Dec-2012 -
As part of Alkermes plc, Alkermes Contract Pharma Services, provides solid oral dosage product development, scale–up and manufacturing services as well as sterile fill finish capabilities to the global pharmaceutical market. This case study demonstrates how a commercial manufacturing partnership...
Technical / white paper
Lyophilized Pharmaceuticals: A Design Space Approach - Baxter
29-Oct-2012 -
This presentation by Steven Nail, PhD and principal Scientist for Baxter BioPharma Solutions, discusses development of design spaces for lyophilized pharmaceutical products in the context of the Quality by Design regulatory paradigm.
Video
TLM Pharma – Packaging Line for Vials - Schott Relations GMBH
11-Jun-2012 -
A Russian customer is currently packing 20 different packages on his new TLM pharma-machine. They are packed with various vials in packaging boxes with differing content.
Technical / white paper
Finding the right contract manufacturer - Vetter Pharma International GmbH
06-Jun-2012 -
Contract manufacturing became popular in many industries during the 1990s as a way to counter rising costs and to reinvestment. The pharmaceutical industry has been slow to adopt this practice because of its absolute need for secrecy.However, with fewer blockbuster...
Technical / white paper
A Clinical Perspective on IV Medication Delivery - Baxter
09-Apr-2012 -
Management of medication delivery through intravenous (IV) administration is a complex and challenging task for pharmacists. The information provided reflects research conducted assessing medication delivery practices and preferences.
Technical / white paper
The Scientific Path to Cycle Development - Baxter
20-Feb-2012 -
To optimize lyophilization cycle times and improve stability for complex injectables, Baxter’s BioPharma Solutions contract manufacturing business established the Lyophilization Center of Excellence, an industry-leading resource for development of high-quality freeze drying.
Technical / white paper
Container Testing: Quantifying Metal Contaminants - SGS
18-Oct-2011 -
Regulatory Agencies have clearly established the need to identify and control harmful chemicals which may leach from container closure systems into the final packaged drug product. But USP <661> colorimetric methods for detecting heavy metal contaminants are known to be...
Technical / white paper
Extractables and Leachables in Pharma - Solvias AG
06-Jun-2011 -
Extractables and Leachables are a hot topic in pharma. Learn more why this is of concern and how testing for leachables as well as extractables should be conducted.
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.
Corden Pharma ~ Experts Taking Care
CordenPharma is a full-service CMO partner in the cGMP Contract Development and Manufacturing of oral, sterile, highly potent and antibiotic pharmaceutical Drug Products, their Active Pharmaceutical Ingredients (APIs), and associated Global Supply Chain and Packaging Services.
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.
Alkermes Contract Pharma Services
Alkermes Contract Pharma Services provides product development scale-up and manufacturing services to the pharmaceutical market and is part of Alkermes plc. With over 40 years in the service business, we have assisted our blue chip list of partners in the successful launch of multiple products in more than 100 countries, including North America, Europe and Asia.
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.
Recipharm AB
Recipharm AB is a leading contract development and manufacturing organisation (CDMO) based in Sweden employing some 1,700 employees.
Famar
Established in 1949, Famar is one of Europe’s leading providers of Contract Development and Commercial Manufacturing services to the pharmaceutical and personal care industries. We are presently within the Top 5 & Top 3 worldwide and in Europe respectively -based on Volumes (700mio packs) and Turnover (€ 380M).
