Cambrex Corporation API, intermediates, drug delivery, active pharmaceutical ingredients, high potency, controlled substances, high energy compounds, generics, small molecule, chiral technology, custom development, customer manufacturing,...
Conforma N.V. Contract Manufacturing Organization. GMP and ISO 13485 certified. Production of non-sterile Liquids and Semi-solids (creams, gels, ointments, ...).
Contract Pharmaceuticals Limited How do you go about choosing a contract manufacturing supplier? Quality, is paramount to the success of any organization. As your requirements are ever-changing, flexibility is critical. And of course, a higher level of...
Catalent Pharma Solutions, Inc. Catalent offers a full range of product development services such as pre-clinical support, API development, analytical services, drug delivery development, clinical manufacturing, packaging, and regulatory consulting...
Clinical manufacturing
Our aseptic liquid formulation and filling facility is cGMP validated. We utilize segregated Class 100 aseptic filling suites, controlled manufacturing and...
Ben Venue Laboratories, Inc. Ben Venue Laboratories is a leader in the manufacture of sterile injectable and cytotoxic products. Since its founding in 1938, Ben Venue has developed extensive capacity and scientific expertise in the field of sterile...
Patheon Inc. Patheon Inc. is a leading global provider of contract development and manufacturing services to the pharmaceutical industry. Patheon prides itself in providing the highest quality products and services to more than 300...
Controlled Substances
Patheon is well positioned to meet our customers' requirements for the manufacture of pharmaceutical dosage forms containing controlled substances. Six of...
AAIPharma Services Corp. Our services include: clinical packaging/distribution, solid dose & sterile contract manufacturing, analytical services, formulation development for solids and liquids, validation services, regulatory affairs and oral...
Clinical Packaging and Distribution
Whether you require clinical or commercial packaging, AAIPharma Services can meet your needs. For clinical trial supplies, AAIPharma Services can provide...
Oral Drug Delivery Systems
AAIPharma Services Formulation Development group has improved the pharmacokinetics of several drugs by developing technologies, processes, expertise, and...
Solid Dose Manufacturing
AAIPharma Services' solid dose manufacturing facility is located in Wilmington, North Carolina. The plant specializes in solid oral dosage forms, toxic and...
There are often problems implementing conventional methods of controlling particulate exposures during many pharmaceutical manufacturing processes. Pharmaceutical manufacturing processes tend to be less flexible than similar chemical manufacturing processes due to the high level of regulation within the industry (i.e., Food and Drug Administration (FDA)). In addition, because the products are ...
A database coupled to a statistical analysis program is an effective means for defining a control space, determining process capability of components, establishing specifications for components and drug product and potentially correlating leachable levels to component extractable levels.
It is a universal truth that research, development manufacture and formulation of potent active pharmaceutical ingredients (APIs) and products requires both “hardware” ( facilities, equipment and engineering controls) and “software” (programs, practices and procedures) to adequately protect personnel and the environment. When employing third party contracting organizations, there is a need to ...
While “going green” is a recent cliché, it is also a key factor to consider when developing a product or modifying a process. In today's economic climate, the regulated product manufacturer needs to perform a thorough cost-benefits analysis before considering such a change. The obvious benefit of going green is the environmental aspect. However, the potential competitive benefits need to be ...
The advent of bubble elimination in a prefilled syringe offers many advantages worth exploring prior to deciding how a product is to be packaged for clinical studies or commercial distribution. This technique further enhances the benefits of prefilled syringes. Prefilled syringes vs. vials have become the container of choice for parenteral drug delivery. The increase in their use is directly ...
In an era characterized by the need to continuously evaluate and bolster R&D pipelines, the increasing complexity and overall cost to develop and approve drug products, the trend toward genericization, and mounting pressures to both decrease prices and maximize profitability, the pharmaceutical industry has sought competitive advantage in lower cost manufacturing jurisdictions.
The ...
The core of any good clinical supply chain system is a supply management system that addresses all of the nuances of clinical supplies. Although Clinical Supply Management is often considered a back-office business unit for a sponsor, it is almost always on the critical path of the drug development process. The efficient, accurate and timely delivery of material to the investigators is critical ...
This paper documents a solution provided by DMC to one of its customers in the form of a vision inspection and data acquisition system. DMC is an engineering consulting company that provides custom software solutions for its customers. For this project the customer is a company that operates chemical plating processes for metal products. In this solution, a “smart” digital camera is set up and ...
On the surface, providing a specified humidity and temperature for stability testing may appear easier to achieve than the 5% RH and 2C ICH guidelines would seem to indicate. The ability to control humidity at 2% does not mean that you are safely within the 5% RH tolerance dictated by ICH.
The ability to produce a recording, display, or printout that is within a specified tolerance may not be a ...
Chemical categorization (or banding) of inherent toxicity and potency linked with defined safe work environments including exposure controls has become an integral component of assuring the health and safety of research workers and manufacturing personnel in the pharmaceutical industry but is not a substitute for quantitative risk assessment in the workplace.
Watch this video to learn more about the Hyaluron Contract Manufacturing syringe filling system.
Inova H3-5V
1 mL long to 20 mL
up to 100,000 units per ...
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