Pharma Services Category of AMRI

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In accordance with CFR 21 Part 211.170 – Production Retains Storage and Complaint Handling, AMRI provides storage of reserve samples.

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AMRI provides complete package integrity testing services in accordance with regulatory guidances.

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Our continuous flow processing capabilities offer unique advantages compared with batch processes, resulting in faster, safer and more robust material production with higher selectivity of desired products.

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AMRI provides custom synthesis and contract manufacturing services at small and large scale for all phases of discovery, development and manufacturing.

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AMRI offers cGMP manufacturing of your API in small scale and in production scale. AMRI handles small-scale API production critical for discovery and development, GMP scale in Albany and manufacturing at our global API facilities.

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Certified by SafeBridge®, AMRI's facilities provide the most advanced technology for the production and safe containment of your compound.

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AMRI provides custom synthesis and contract manufacturing services at small and large scale for all phases of discovery, development and manufacturing. Our teams bring extensive chemical and technical expertise to develop flexible for your needs.

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AMRI is one of the leading producers of complex APIs using fermentation. We offer comprehensive biocatalysis capabilities, including rapid biocatalytic screening and evaluation, and process development & optimization at both pilot and commercial-scale.

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AMRI is your trusted partner, providing expert solutions for the safe, secure development and manufacture of controlled substances.

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AMRI offers specialized aseptic formulation development and manufacture of small batches for early-stage clinical trials.

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AMRI offers expertise and capabilities to manufacture proteins and peptides.

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AMRI offers expertise and capabilities to manufacture monoclonal antibodies.

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AMRI offers GMP manufacturing and expertise in final dosage forms for topical and intravitreal ophthalmic products, including standard bottles, sterile multi-use bottles and prefilled syringes or vials.

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With expertise in characterizing and modifying a drug substances' physical, chemical and mechanical properties, our objective is to help you assess and choose the best solid form for progression into animal and human dosing trials.

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AMRI's expert scientists routinely isolate materials of interest, including controlled substances and potent compounds, through classic and chromatographic techniques.

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AMRI’s inventory of chromatography media for preparative applications (chiral and achiral) provides extensive screening options as well as quicker turnaround on the processes.

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AMRI's scientists apply LC/MS as a profiling technique to systematically monitor process-related impurities and degradants.

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To accelerate your efforts in discovery and development, AMRI offers a fine chemicals catalog with more than 700 compounds.

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Strengths of AMRI's small-scale manufacturing platform include clinical API manufacturing and clinical drug product manufacturing up to 10kg, including oral drug products and sterile fill and finish.

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AMRI’s team of scientists supports all your chemical development needs, offering integrated, continuous service through the drug development life cycle.

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AMRI offers extensive expertise, facilities, experience and execution for assessing, developing, and implementing API syntheses that benefit from fermentation, biocatalysis, synthetic biology, and related approaches.

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Our scientists bring more than 15 years of experience in the field of organometallic chemistry and a global infrastructure to deliver a wide range of high-quality compounds at large scale.

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AMRI offers specialized aseptic formulation development and manufacture of small batches for early-stage clinical trials.

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AMRI provides extensive technical expertise in the development, scale-up and GMP manufacture of liquid and lyophilized sterile dosage form products and offers solutions for a variety of compound categories, such as small and large molecules and controlled