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Drug Master File Document Production Services
101 services found
by:Alfred E. Tiefenbacher (GmbH & Co. KG) based inHamburg, 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 product development and registration through to production, timely ...
by:Lifecore Biomedical, Inc. based inChaska,, MINNESOTA (USA)
Depending upon the requirements of the drug product, a variety of filling conditions can be tested and equipment ...
Manufactured by:Perrery Farmaceutici S.r.l. based inPescantina (VR), ITALY
Pharmaceutical innovation is a complex creative process, which involves much more than, in fact, research. An important task of the system of creation and introduction of new drugs into production is to ensure interrelation with other enterprise processes related to the drug life-cycle. This approach makes it possible to ensure the quality of the product along the whole technological chain, that ...
Manufactured by:Creative Biogene based inShirley, NEW YORK (USA)
Therapeutic antibodies are highly regarded for their high affinity, specificity, low immunogenicity, and ability to target a wide range of biological molecules. Currently, mammalian cells, including Sp2/0, NS0, HEK293, and CHO cells, are primarily used for the production of therapeutic antibodies, with CHO cells accounting for over 70% of the production due to their complex posttranslational ...
by:IUCT based inMollet del Vallès, SPAIN
IUCT is authorized by the General Inspection and Control of Medicines of the Spanish Drug and Health Products Agency as pharmaceutical drug manufacturer (4155-E). For this has a manufacturing plant of approximately 200 m2 and laboratories for the analitycal ...
Manufactured by:Alfa Chemistry based inNY, NEW YORK (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 biomanufacturing needs. In addition, Alfa CDMO delivers our ...
Manufactured by:CD Formulation based in, NEW YORK (USA)
Bioavailability refers to the degree and speed at which a drug is absorbed into the blood circulation. There are ongoing challenges with poorly water-soluble drugs and have failed to reach the market due to their poor water solubility. CD Formulation has developed a range of technologies and formulation expertise to improve the solubility and bioavailability of these drugs, helping customers find ...
by:Nexreg Compliance Inc. based inLondon, ONTARIO (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 of prescription and over-the-counter drug products approved for sale ...
Manufactured by:Cambrex Corporation based inEast Rutherford, NEW JERSEY (USA)
Cambrex provides a seamless method on-boarding process to establish robust methodology at our sites. We have extensive equipment capabilities that allow us to support full release and routine testing. ...
Manufactured by:Alfa Chemistry based inNY, NEW YORK (USA)
The stability of pharmaceutical products refers to the ability of APIs and preparations to maintain their physical, chemical, biological and microbiological properties. The purpose of stability study is to investigate the changes of the properties of APIs or preparations with time under the influence of temperature, humidity, light and other conditions, so as to provide a scientific basis for the ...
Manufactured by:CD Formulation based in, NEW YORK (USA)
Light stability testing in the pharmaceutical industry is necessary to ensure the potency, efficacy and safety of manufactured products in clinical use. Photostability testing of APIs and products is performed according to ICH Q1B guidelines, and the selection of an appropriate light source is an important consideration for consistent results. Photodegradation of drugs in products is a function ...
by:BioConnection based inOss, NETHERLANDS
When your product leaves our facility, it needs a few additional steps in order to be ready for the clinic. These steps can also be provided by BioConnection. Depending on your needs and requirements, we can setup the further chain into the clinic. It’s a total package! ...
by:Ardena Holding NV based inMariakerke, 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 materials. Preparation and translation of multi-language label ...
Manufactured by:Rentschler Biopharma SE based inLaupheim, GERMANY
Rentschler Biopharma’s strategic alliance with Leukocare offers best-in-class formulation development considered at every step of the biopharmaceutical development and manufacturing process. ...
by:Ardena Holding NV based inMariakerke, BELGIUM
At Ardena, we are experts in writing scientific and technical reports using a dossier-centric approach. This means we keep the final dossier submission in mind throughout to ensure consistency, completeness and ...
Manufactured by:CD Formulation based in, NEW YORK (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 development, scale-up production, and commercial manufacturing, our pharmacy experts ...
Manufactured by:ApiJect Systems, Corp. based inStamford, CONNECTICUT (USA)
Offering Design, Engineering and Testing of ApiJect’s High Volume Process for Manufacturing Single-Dose, Prefilled ...
Manufactured by:RheaVita based inGent, BELGIUM
During freeze-drying, biopharmaceutical and other products require protection against dehydration stress during freeze-concentration and drying. Therefore, a suitable formulation strategy is essential to guarantee the long-term stability of drug products. This strategy could include adding protectants to withstand the dehydration stress, selecting a suitable buffer to maintain a constant pH ...
Manufactured by:CD Formulation based in, NEW YORK (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 product without serious, or unacceptable, changes in effectiveness and stability of drug products, ...
Manufactured by:CELONIC Group based inBasel, 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 batches, our scientists are highly experienced in keeping ...