Drug Production Services
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based in NETHERLANDS
When you’re developing a finished dosage form, your project costs are most likely in a sound competition with your available funds. This is why choosing a CDMO is an important and long term decision. BioConnection can help you out with an oversight of the technology transfer and per-unit manufacturing cost. Let us also assist you with determining the often hidden costs: depending upon the ...
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based in BELGIUM
At Ardena, we guide our customers into making smarter formulation choices. Ultimately, this reduces the risk of clinical failure and ensures your product reaches the clinic rapidly via the most efficient route. Solving a problem and saving time Overcoming development challenges is our speciality. We work with customers to understand their ...
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Manufactured by CELONIC Groupbased in SWITZERLAND
We offer comprehensive Fill & Finish services for liquid-formulated drug products – from aseptic filling to QC tests, labeling, packaging, storage, and release. Our solution-driven GMP-complaint processes come with unparalleled flexibility, fully-adaptable to the unique needs of our clients. Having completed over 300 GMP filling ...
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Manufactured by CD Formulationbased in USA
In order to ensure the safety of drug product quality, the packaging system that comes into direct contact with the drug product needs to meet compatibility requirements. Compatibility studies refer to the process of evaluating packaging components or systems that are in direct contact with the drug ...
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based in USA
Depending upon the requirements of the drug product, a variety of filling conditions can be tested and equipment ...
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based in CANADA
Nexreg can work with your company to develop drug product labels which meet Canadian requirements. As well, Nexreg's team of experts will complete the DIN Submission Certification form required by the Therapeutic Products Directorate (TPD) of Health Canada. The Drug Identification Number (DIN) is the number located on the label ...
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based in GERMANY
In addition to offering an extensive portfolio of in-house developed generic drug products across indications, AET has started the development of biosimilars and innovative product designs. AET provides a comprehensive service from project concept (including global portfolio and IP strategy and competitive product design) via ...
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Manufactured by Advanced Microdevices Pvt. Ltd. (mdi)based in INDIA
We comprehend and value the critical importance of establishing drug product wetted integrity test specifications to ensure filter efficiency. The drug product / process fluid, due to different components, may have different surface tension than the filter manufacturer specified wetting fluid, impacting the drug ...
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Manufactured by Alfa Chemistrybased in USA
Alfa CDMO provides global CDMO services in the development and manufacturing of biopharmaceuticals, including mAbs, recombinant proteins, ADCs and bispecifics. We offer our partners contract services from DNA to finished drug product. Our technical expertise allows us to provide effective high-quality solutions for our partners ...
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Manufactured by Advanced Microdevices Pvt. Ltd. (mdi)based in INDIA
Our microbial retention studies qualify the filter under test to repeatedly produce a sterile filtrate with the drug product under simulated worst case process conditions in accordance to: USFDA CDER guidance document on Sterile Drug Products Produced by Aseptic Processing. PDA Technical Report No. 26, Revised 2008 on Sterilizing ...
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based in USA
Drug product formulation development starts with an understanding of the drug substance. Our experts work with you to define and understand the anticipated use, desired performance criteria, characteristics of the drug product, distribution, storage, and ...
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by Vetterbased in GERMANY
Our experts provide the guidance, insight, and Vetter process documentation you need to prepare a Common Technical Document (CTD) for clinical trials of your injectable drug ...
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Manufactured by CD Formulationbased in USA
and bioavailability of these drugs, helping customers find the right way to commercialize their drug products. This experience, along with a variety of techniques, enables CD Formulation to overcome many of the hurdles surrounding solubility and bioavailability, including physical, chemical, encapsulation techniques and so on. Learn more at ...
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Manufactured by CD Formulationbased in USA
CD Formulation's Contract Development and Manufacturing (CDMO) division is a leader in drug development and drug delivery pathway development, offering services such as bioresorbable particle system development. CD Formulation also offers integrated services from evaluation of drug formulation to drug product ...
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Manufactured by ApiJect Systems, Corp.based in USA
Our device and BFS manufacturing experts will work with your team to fill-finish your drug product in one of our customized prefilled drug delivery systems at scale. ...
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Manufactured by Ascendia Pharmaceuticalsbased in USA
Biological formulation development involves discovering solutions for the most bioactive, native protein delivery. It poses a myriad of challenges due to the fact biologics consist of generally large, complex molecules that complicate drug development. Biologics are at the forefront of many current medical advances. They have established a ...
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based in USA
Lifecore’s analytical development team has broad experience with Compendial methods, transferring client developed test methods, and developing unique methods for assaying drug products and ...
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based in BELGIUM
Our services include: Primary packaging of in-house or externally produced drug product (capsules, tablets, …) in different types of containers (bottles, tubes, sachets, …). Secondary packaging including patient kit assembly and labelling ready for use in the clinic. Use of tamperproof primary and secondary packaging ...
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based in USA
Supporting client requirements from creation to maintenance of global and local drug product labeling. Regulatory Labeling regulations are essential for ensuring compliance of drug products to be used safely and with efficacy by patients. However, regulatory labeling compliance requirements can differ across regions and new ...
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Manufactured by Alfa Chemistrybased in USA
conditions, so as to provide a scientific basis for the determination of drug production, packaging, storage, transportation conditions and validity. T,C&A Lab runs strictly in accordance with GMP and GLP standards to meet the relevant requirements of compliance, quality, efficiency in terms of Stability Testing of Pharmaceutical ...
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