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    Pharma Services Category of Cambrex Corporation

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    HTL Biotechnology is the world leader in the responsible development and production of pharmaceutical-grade biopolymers.
    Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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    01 API Development (9)

    02 Analytical Method Development (2)

    03 Analytical Testing Services (3)

    04 BioAnalytical Services (1)

    05 Biologics, Bioprocess & Fermentation (2)

    06 Capsule (1)

    07 Chiral Synthesis (1)

    08 Contract Manufacturing (1)

    09 Contract Services (3)

    10 Cream / Lotion / Ointment (1)

    11 Custom Synthesis & Manufacturing (1)

    12 Extractables and Leachables (1)

    13 Formulation Development (11)

    14 Gel (1)

    15 High Potency APIs (HPAPIs) (1)

    16 Liquid (1)

    17 Preformulation & Material Science (1)

    18 Small Molecules (1)

    19 Stability Studies (1)

    20 Tablet (1)

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    01 Cambrex Corporation (44)

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    Cambrex Corporation

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    DRUG SUBSTANCE CUSTOM DEVELOPMENT

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    We deliver your custom small molecule API development projects on time, within budget and to the highest quality standards. We have the expertise, flexibility and resources to provide a full range of pharmaceutical API custom development services.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Custom Synthesis
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    ROUTE SELECTION

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    We offer range of custom small molecule API development capabilities including Route selection, Process development & optimization, Contract process research, Analytical development & Validation, Synthesis & purification of analytical reference standards

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Route Evaluation & Development
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    PROCESS DEVELOPMENT & VALIDATION

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    Our pharmaceutical process development services combine creative solutions to early phase challenges with a thorough knowledge of the rigours of validation. The result is more efficient preparation of your APIs and intermediates.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Process Development & Optimization
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    ANALYTICAL DEVELOPMENT & VALIDATION

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    Cambrex focuses on efficiently developing robust and high- quality analytical methods that deliver reliable results. We have a vast range of capabilities in instrumentation and detectors including high-throughput column screening.

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    Pharma Service: Analytical

    Category: Analytical Method Development

    Sub Category: Method Development and Validation
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    ICH COMPLIANT STABILITY STUDIES

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    In addition to traditional shelf-life stability studies, Cambrex routinely performs specialized studies such as freeze/thaw, compatibility, & photo stability studies. Our analytical experts can support your stability testing at all phases of development.

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    Pharma Service: Analytical

    Category: Stability Studies

    Sub Category: Overview
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    SCALE-UP & COMMERCIALIZATION

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    Utilizing our development and testing capabilities provides for a seamless, efficient transition to full commercial scale-up. Development, scale-up and commercialization can be easily facilitated and performed at the same location.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Scale-Up Capabilities
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    REFERENCE STANDARD QUALIFICATION

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    Cambrex has a distinct niche for qualifying and managing reference standards over the life of your molecule.Partnered with our process chemists, we have the capability to synthesize additional reference materials and markers and qualify them for GMP use.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

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    HIGH POTENCY API MANUFACTURING

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    Cambrex offers customers an end-to-end partnership for the research, development & manufacture of small molecule APIs at every stage of the life cycle. Cambrex has been developing & manufacturing a broad spectrum of HPAPIs and compounds for >15 years.

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    Pharma Service: API Manufacturing

    Category: High Potency APIs (HPAPIs)

    Sub Category: Overview
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    CHIRAL COMPOUND MANUFACTURING

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    At Cambrex, we have the technology and expertise to meet your chiral compound needs. Using biotransformation technology, our expert team can produce chiral compounds.

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    Pharma Service: API Manufacturing

    Category: Chiral Synthesis

    Sub Category: Overview
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    BIOCATALYSIS

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    Our biocatalysis development services allow us to provide our customers with highly pure regio-, chemo- and enantioselective compounds, when compared to traditional chemical synthesis.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Biocatalysis
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    ENZYME SCREENING & DEVELOPMENT

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    Our team of experts can custom develop processes, design and optimize routes and provide R&D screening services using our proprietary library of more than 600 enzymes.

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    Pharma Service: API Manufacturing

    Category: Biologics, Bioprocess & Fermentation

    Sub Category: Overview
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    PROCESS DEVELOPMENT & ENZYME MANUFACTURING

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    Our team of experts can custom develop processes, design and optimize routes and provide R&D screening services using our proprietary library of more than 600 enzymes.

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    Pharma Service: API Manufacturing

    Category: Biologics, Bioprocess & Fermentation

    Sub Category: Overview
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    IMPURITY ISOLATION AND IDENTIFICATION

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    At Cambrex we have a proven track record of identifying, isolating and characterizing impurities. Areas of expertise and capabilities include mass spectrometry (MS), preparative and semi-preparative chromatography, and NMR spectroscopy.

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    Pharma Service: Analytical

    Category: Analytical Method Development

    Sub Category: Impurity Isolation and Identification
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    CHEMICAL CHARACTERIZATION

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    We offer Integrating Capabilities of Building product safety into process design under one roof, which can facilitate a smooth product launch by ensuring minimal impact from impurities, all while mitgating risks associated with the final product.

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    Pharma Service: Analytical

    Category: Extractables and Leachables

    Sub Category: Chemical Characterization
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    PHYSICAL CHARACTERIZATION

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    Cambrex have the expertise to evaluate materials using a variety of techniques. Characterization of materials is performed using Polarizing Light Miscroscopy (PLM), DSC, Thermogravimetric Analysis (TGA), Laser Particle Size (LPS), & XRPD.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Physical Characterization
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    PARTICLE SIZE DETERMINATION

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    Cambrex is equipped with laser particle size (LPS) instrumentation to ensure materials are consistent from batch to batch. If further investigation is necessary, we can provide large population particle imaging and size and shape morphology results.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Particle Size
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    BIOANALYTICAL & BIOPHARMACEUTICAL ANALYSIS

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    Cambrex has extensive experience in Drug Metabolism and Pharmacokinetic (DMPK), Bioanalytical and Biopharmaceutical Analyses.

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    Pharma Service: Analytical

    Category: BioAnalytical Services

    Sub Category: Overview
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    HIGH POTENCY APIs (HPAPIs)

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    Cambrex has been reliably developing and manufacturing high potency APIs & compounds for years, including: Immunosuppressants, cytostatics/protein kinase inhibitors, ultra-potent cytotoxic drug substances, drug linkers, drug product intermediates, etc.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: High Potency APIs (HPAPIs)
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    CONTROLLED / IMMEDIATE / MODIFIED RELEASE

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    Cambrex’s drug product manufacturing and packaging capabilities cover a wide range of specialist dosage forms, including controlled substances, sterile and non-sterile forms for pediatric and fixed dose combination products

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Controlled / Immediate / Modified Release
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    TECHNOLOGY TRANSFER

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    With Cambrex, the tech transfer process is quicker, simpler and seamless, with full and consistent support provided throughout. We ensure confidence in an efficient & successful transfer at all stages of a drug’s lifecycle.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Tech Transfer
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    CONTROLLED SUBSTANCE DRUG PRODUCT DEVELOPMENT

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    Cambrex is a contract development & manufacturing organization (CDMO) that offers controlled substance manufacturing & packaging services. They have experience in the importation & production of controlled substances & precursor chemicals.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Controlled Substance
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    TOPICAL DEVELOPMENT & MANUFACTURING

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    Cambrex's development facilities provide seamless transitions from pre-formulation & formulation development to clinical & commercial supply. Our state-of-the-art technologies & equipment support the complete range of topical development & manufacturing.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Topical
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    DMPK

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    Cambrex DMPK – Bioanalytical Services include ADME, Hepatocyte Stability, Microsomal Stability, S9 Stability Plasma Stability, Simulated Fluid Stability, Tissue Stability, Reactive Metabolite Assessment (Glutathione Trapping), etc

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    Pharma Service: API & Drug Product Development

    Category: Preformulation & Material Science

    Sub Category: PK / PD / TK
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    cGMP API CUSTOM MANUFACTURING

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    With quality, innovation and flexibility, we offer pharmaceutical custom manufacturing excellence. Our extensive small molecule API custom manufacturing capabilities takes your project from early phase development to scale-up & commercial manufacture.

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    Pharma Service: API Manufacturing

    Category: Custom Synthesis & Manufacturing

    Sub Category: Overview
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    DRUG SUBSTANCE CONTRACT MANUFACTURING

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    With quality, innovation and flexibility, we offer pharmaceutical custom manufacturing excellence. Our extensive small molecule API custom manufacturing capabilities takes your project from early phase development to scale-up & commercial manufacture.

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    Pharma Service: API Manufacturing

    Category: Contract Manufacturing

    Sub Category: Overview
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    BLISTER PACKAGING

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    Cambrex offers final packaging for solid, liquid, and semi-solid, non-sterile & sterile dosage forms – customerready or in custom forms. From blister packs to blister hospital unit dose and physician samples, we specialize in every shape and form.

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    Pharma Service: Packaging

    Category: Contract Services

    Sub Category: Blister
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    BOTTLE PACKAGING CAPABILITIES

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    Our packaging capabilities include bottles with regular and child resistant closures, tamper evident seals, plastic and glass bottles, Slat counters on all solid dosage form lines, Blister packs with PVC, PVDC, Aclar and other flexible materials, etc

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    Pharma Service: Packaging

    Category: Contract Services

    Sub Category: Bottle
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    POUCH / SACHET / STICK PACK

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    We have extensive experience in the manufacture and packaging of stick packs and provide our customers with flexible, quality led development and commercialization solutions.

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    Category: Contract Services

    Sub Category: Pouch / Sachet / Stick Pack
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    DRUG PRODUCT CAPABILITIES - TABLET

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    Our drug product capabilities cover a wide variety of manufacturing & packaging technologies and we can support many dosage forms. We specialize in solid dosage forms, liquid, gel, cream and ointment products, sterile gel, and finished goods packaging.

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    Category: Tablet

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    DRUG PRODUCT CAPABILITIES - CAPSULE

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    Our drug product capabilities cover a wide variety of manufacturing & packaging technologies and we can support many dosage forms. We specialize in solid dosage forms, liquid, gel, cream and ointment products, sterile gel, and finished goods packaging.

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    Pharma Service: Drug Product Manufacturing

    Category: Capsule

    Sub Category: Overview
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    DRUG PRODUCT CAPABILITIES - LIQUID

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    At Cambrex, we offer contract development and manufacturing services specializing in liquid dosage forms. We offer fully integrated pharmaceutical development and manufacturing services for liquid dosage forms including oral solutions and suspensions,

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    Pharma Service: Drug Product Manufacturing

    Category: Liquid

    Sub Category: Overview
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    CONTRACT MANUFACTURING AND PACKAGING OF GELS

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    Our drug product capabilities cover a wide variety of manufacturing & packaging technologies and we can support many dosage forms. We specialize in solid dosage forms, liquid, gel, cream and ointment products, sterile gel, and finished goods packaging.

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    Pharma Service: Drug Product Manufacturing

    Category: Gel

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    CREAM & OINTMENT PRODUCTS

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    Our drug product capabilities cover a wide variety of manufacturing & packaging technologies and we can support many dosage forms. We specialize in solid dosage forms, liquid, gel, cream and ointment products, sterile gel, and finished goods packaging.

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    Pharma Service: Drug Product Manufacturing

    Category: Cream / Lotion / Ointment

    Sub Category: Overview
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    CREAM / GEL / LOTION / OINTMENT

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    With fully integrated development and manufacturing services for solid dosage forms (Tablet, Capsule & Powder), liquids, creams and both sterile and non-sterile ointments, our experts develop and manufacture drug products with success.

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    Category: Formulation Development

    Sub Category: Cream / Gel / Lotion / Ointment
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    GRANULES & PELLETS

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    At Cambrex, we have the capacity to produce up to 1500 kg of bulk powder and granules. In addition we can also produce large batches of tablets and capsules with our high-speed compression and encapsulation equipment.

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    Sub Category: Granule / Pellets
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    INTEGRATED DEVELOPMENT, MANUFACTURING-CAPSULE

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    With fully integrated development and manufacturing services for solid dosage forms (Tablet, Capsule & Powder), liquids, creams and both sterile and non-sterile ointments, our experts develop and manufacture drug products with success.

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    Sub Category: Capsule
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    INTEGRATED DEVELOPMENT & MANUFACTURING-POWDER

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    With fully integrated development and manufacturing services for solid dosage forms (Tablet, Capsule & Powder), liquids, creams and both sterile and non-sterile ointments, our experts develop and manufacture drug products with success.

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    Category: Formulation Development

    Sub Category: Powder / Blend
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    INTEGRATED DEVELOPMENT & MANUFACTURING-TABLET

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    With fully integrated development and manufacturing services for solid dosage forms (Tablet, Capsule & Powder), liquids, creams and both sterile and non-sterile ointments, our experts develop and manufacture drug products with success.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Tablet
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    LIQUID FORMULATION

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    With fully integrated pharmaceutical development and manufacturing services for liquid dosage forms including oral solutions and suspensions, we can help you successfully develop and manufacture your liquid product.

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    Category: Formulation Development

    Sub Category: Liquid Formulation
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    FORMULATION DEVELOPMENT OF SUSPENSION

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    Cambrex, a fully integrated CDMO, provides development & manufacturing services for oral solid dosage forms (Tablet, Capsule & Powder), liquids (suspensions, Solutions & Drops), creams. Their experts develop and manufacture drug products with success.

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    Category: Formulation Development

    Sub Category: Suspension
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    CDMO FOR CONTROLLED SUBSTANCE APIs

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    Cambrex is a CDMO for controlled substance APIs and highly potent controlled APIs. It is a contract manufacturer of controlled substances that also offers services for controlled API development and controlled drug product development.

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    Category: API Development

    Sub Category: Controlled Substance
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    API CLINICAL SUPPLY

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    Cambrex has the expertise, flexibility and resources to provide a full range of pharmaceutical API custom development services ranging from pre-clinical to Phase III clinical trials and technology transfer for commercial supply.

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    Category: API Development

    Sub Category: Clinical Supply
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    CUSTOM SMALL MOLECULE API DEVELOPMENT

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    Cambrex has a range of custom small molecule API development capabilities, including route selection, process development and optimization (early to late stage, small to large scale), contract process research, controlled substances R&D, etc.

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    Category: API Development

    Sub Category: Small Molecules
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    SMALL MOLECULE API CUSTOM MANUFACTURING

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    Cambrex offers small molecule API custom manufacturing from early phase development to scale-up & commercial manufacturing. It also provides services including lab, kilo & pilot scale manufacturing for pre-clinical studies & all phases of clinical trials.

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    Category: Small Molecules

    Sub Category: Overview
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