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    Pharma Services Category of Sai Life Sciences Limited

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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 (11)

    02 Analytical Method Development (1)

    03 Antibody Drug Conjugate (1)

    04 Chiral Synthesis (1)

    05 Early Clinical / Phase I-IIa (1)

    06 Fine Chemical / Intermediate (1)

    07 Formulation Development (15)

    08 GMP Manufacturing (1)

    09 Hydrogenation (1)

    10 Lyophilization (1)

    11 Preformulation & Material Science (5)

    12 Scale Up (1)

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    01 Sai Life Sciences Limited (40)

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    Sai Life Sciences Limited

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    ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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    Sai Life Sciences offers analytical method development & validations for NCEs. Structure identification & confirmation of impurities is integral part of the analytical method development.

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    Pharma Service: Analytical

    Category: Analytical Method Development

    Sub Category: Method Development and Validation
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    cGMP SCALE UP

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    Sai Life Sciences helps innovator biotech & pharma companies accelerate their drug discovery journey from HIT to IND using creative chemistry supported by high quality biology, DMPK, toxicology, cGMP scale-up & formulation services.

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    Pharma Service: API Manufacturing

    Category: Scale Up

    Sub Category: Overview
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    DRUG CONJUGATES FOR ADCs

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    Sai Life Sciences has experience across a wide range of chemistries - asymmetric synthesis, drug conjugates for ADCs, chiral pool synthesis, heterocycles, isotope labelled (13C & 2D) synthesis, nucleosides & nucleotides, peptides, steroids, etc.

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    Pharma Service: API Manufacturing

    Category: Antibody Drug Conjugate

    Sub Category: Overview
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    APIs & INTERMEDIATES MANUFACTURING

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    Sai Life Sciences provides GMP Active Pharmaceutical Ingredients (APIs) and intermediates for late clinical phase and commercial New Chemical Entities for US, European and Japanese innovators.

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    Pharma Service: API Manufacturing

    Category: Fine Chemical / Intermediate

    Sub Category: Overview
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    LYOPHILIZATION CAPABILITIES

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    Sai Life Sciences has FDA & PMDA-certified facilities with various capabilities such as lyophilization, hydrogenation, cryogenics & commercial chromatography.

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    Pharma Service: API Manufacturing

    Category: Lyophilization

    Sub Category: Overview
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    GMP MANUFACTURING

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    Sai Life Sciences provides GMP Active Pharmaceutical Ingredients (APIs) and intermediates for late clinical phase and commercial New Chemical Entities for US, European and Japanese innovators.

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    Pharma Service: API Manufacturing

    Category: GMP Manufacturing

    Sub Category: Overview
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    HYDROGENATION CAPABILITIES

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    Sai Life Sciences has FDA & PMDA-certified facilities with various capabilities such as hydrogenation, cryogenics, lyophilization & commercial chromatography. They utilize hydrogenators ranging from 0.5 KL to 4 KL that can operate up to 50 bar.

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    Pharma Service: API Manufacturing

    Category: Hydrogenation

    Sub Category: Overview
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    CHIRAL POOL SYNTHESIS

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    Sai Life Sciences has experience across a wide range of chemistries - asymmetric synthesis, chiral pool synthesis, drug conjugates for ADCs, heterocycles, isotope labelled (13C & 2D) synthesis, nucleosides & nucleotides, peptides, steroids, etc.

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    Pharma Service: API Manufacturing

    Category: Chiral Synthesis

    Sub Category: Overview
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    PROCESS DEVELOPMENT

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    Sai Life Sciences delivers a diverse set of NCE development programs involving complex chemical synthesis from route scouting, process development, scale up to commercialization.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Process Development & Optimization
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    ROUTE SCOUTING

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    Sai Life Sciences helps their customers to develop alternate Routes of Synthesis (ROS) along the journey from brainstorming to conducting a techno-commercial evaluation, establishing a proof-of-concept, and finally ensuring sustainability of the process.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Route Scouting
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    SCALE-UP CAPABILITIES

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    Sai Life Sciences delivers a diverse set of NCE development programs involving complex chemical synthesis from route scouting, process development, scale-up to commercial scale.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Scale-Up Capabilities
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    PROCESS SAFETY ASSESSMENT

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    Through fully-equipped Process Safety Labs, Sai Life Sciences conduct igorous, data- driven & comprehensive process and operations safety evaluation from “quote to delivery” giving their clients peace of mind throughout the collaboration.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Process Safety Assessment
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    POLYMORPH SCREENING

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    Sai Life Sciences offer various services such as polymorph identification, stability evaluation performed by PXRD and FTIR, identification & monitoring of polymorphic form, solvates / hydrates, crystalline and amorphous behavior.

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    Pharma Service: API & Drug Product Development

    Category: Preformulation & Material Science

    Sub Category: Polymorph & Crystal Screening
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    PRE-FORMULATION SERVICES

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    Sai Life Sciences offers pre-formulation services to help you choose the correct form of drug substance, determine its physico-chemical properties and evaluate its stability under different condition.

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    Pharma Service: API & Drug Product Development

    Category: Preformulation & Material Science

    Sub Category: Overview
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    SOLID STATE CHARACTERIZATION

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    Sai Life Sciences provides salt screening at early phase of development to check the impact of different counter-ions on physicochemical aspects of the NCE with solubility, counter ion structure and solid state properties.

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    Pharma Service: API & Drug Product Development

    Category: Preformulation & Material Science

    Sub Category: Solid State Characterization
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    DISTILLATION / LIQUID APIs

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    Sai Life Sciences process engineering team is adept at making thermally sensitive products safer for scale-up using technologies such as short-path distillation and ATFE (Agitated thin film evaporator).

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Distillation / Liquid APIs
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    HYDROGENATION CAPABILITY

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    Sai Life Sciences has infrastructure with hydrogenation capacity from 1L up to 1KL, Kilo lab suites.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Hydrogenation
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    PRE-CLINICAL & CLINICAL FORMULATION

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    Sai Life Sciences offers development, pre-clinical and clinical formulation services for your lead compound. They also develop formulations applicable for pre-clinical & Phase 1 studies for peroral, topical and parenteral administration.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Clinical Supply
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    PARENTERAL FORMULATION DEVELOPMENT

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    Sai Life Sciences offers development, pre-clinical, and clinical formulation services for your lead compound. They develop formulations applicable for pre-clinical & phase 1 studies for parenteral, peroral and topical administration.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Injectable / Parenteral
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    TOPICAL FORMULATIONS FOR CLINICAL SUPPLY

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    Sai Life Sciences offers development, pre-clinical and clinical formulation development services for your lead compound. They develop formulations applicable for pre-clinical & phase 1 studies for topical, peroral and parenteral administration.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Topical
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    PARTICLE SIZE REDUCTION & MICRONIZATION

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    Sai Life Sciences engineers processes to achieve optimal particle size and particle size distribution in addition to improving other aspects of particle morphology and physical characteristics.

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    Pharma Service: API & Drug Product Development

    Category: Preformulation & Material Science

    Sub Category: Particle Size Reduction & Micronization
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    SOLUBILITY ENHANCEMENT

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    Sai Life Sciences utilizes several solubilization techniques such as inclusion of cyclodextrin based systems, using buffers, co-solvents and surfactants, use of triglycerides (lipid based screening), micronization to improve solubility, etc.

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    Pharma Service: API & Drug Product Development

    Category: Preformulation & Material Science

    Sub Category: Solubility Assessment & Enhancement
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    TECHNOLOGY TRANSFER

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    For Phase 2 and larger quantity needs, Sai Life Sciences collaborates with external partners, having proven their expertise to transfer the technology developed to sites identified by client across geographies.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Tech Transfer
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    LIQUID ORAL DOSAGE FORMS

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    Sai Life Sciences has vast & rich expertise in working across multiple technologies with increasing complexity to develop a variety of dosage forms such as liquid oral dosage forms, solutions & suspensions, emulsions & micro-emulsions, etc.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Liquid Formulation
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    FORMULATION DEVELOPMENT OF SUSPENSION

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    Sai Life Sciences have vast & rich expertise of working across multiple technologies with increasing complexity to develop variety of dosage forms such as suspensions & solutions, powder for oral solution or suspension, emulsions & micro-emulsions.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Suspension
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    POWDER/BLEND FORMULATION

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    Sai Life Sciences have vast & rich expertise of working across multiple technologies with increasing complexity to develop variety of dosage forms such as powder for oral solution or suspension, solutions & suspensions, emulsions & micro-emulsions.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Powder / Blend
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    EMULSION FORMULATION DEVELOPMENT

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    Sai Life Sciences have vast & rich expertise of working across multiple technologies with increasing complexity to develop variety of dosage forms such as emulsions & micro-emulsions, powder for oral solution or suspension etc.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Emulsion
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    TABLET FORMULATION DEVELOPMENT

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    Sai Life Sciences have vast & rich expertise of working across multiple technologies with increasing complexity to develop variety of solid dosage forms such as conventional tablets, immediate release/modified release tablets, oral disintegrating tablets.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Tablet
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    IMMEDIATE & MODIFIED RELEASE TABLETS

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    Sai Life Sciences have vast & rich expertise of working across multiple technologies with increasing complexity to develop variety of dosage forms such as immediate release/modified release tablets, oral disintegrating tablets & conventional tablets.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Controlled / Immediate / Modified Release
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    LYOPHILIZED FORMULATION DEVELOPMENT SERVICES

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    Sai Life Sciences has vast & rich expertise of working across multiple technologies with increasing complexities to develop a variety of dosage forms such as lyophilized products and ready-to-use liquid parenteral formulations.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Lyophilization
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    DEVELOPMENT OF SEMI-SOLID DOSAGE FORMS

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    Sai Life Sciences provides the development of various topical semi-solid dosage forms such as ointments, creams & gels, etc.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Cream / Gel / Lotion / Ointment
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    FORMULATION DEVELOPMENT OF CAPSULES

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    Sai Life Sciences have vast & rich expertise of working across multiple technologies with increasing complexity to develop variety of dosage forms such as powder blend/granules in capsules, modified release capsules & liquid filled hard gelatin capsules.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Capsule
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    ORODISPERSIBLE TABLET FORMULATION DEVELOPMENT

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    Sai Life Sciences has expertise in working across multiple technologies with increasing complexity to develop a variety of dosage forms such as orally disintegrating (orodispersible) tablets , conventional tablets & immediate/modified release tablets.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Buccal / Orodispersible
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    FORMULATION DEVELOPMENT SERVICES

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    Sai Life Sciences helps innovator biotech & pharma companies accelerate their drug discovery journey from HIT to IND using creative chemistry supported by high quality biology, DMPK, toxicology, cGMP scale-up & formulation development services.

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    Category: Formulation Development

    Sub Category: Overview
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    PREPARATION OF KEY INTERMEDIATES

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    The key services offered by Sai Life Sciences include design & synthesis of analogues to support preparation of building blocks/key intermediates, lead generation and optimization, synthesis of reference compounds and impurity markers, etc.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Fine Chemical / Intermediate
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    SYNTHESIS OF REFERENCE COMPOUNDS

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    The key services offered by Sai Life Sciences include synthesis of reference compounds, lead generation and optimization, preparation of building blocks/key intermediates, metabolites, and impurity markers, etc.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Impurity / Reference Standard
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    ISOTOPE LABELLED COMPOUNDS

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    Sai Life Sciences has experience across wide range of chemistries such as Isotope labelled (13C & 2D) synthesis, asymmetric synthesis, biotinylated/BODIPY/fluorescein labelled compounds, chiral pool synthesis & heterocycles, etc.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Cold Chemistry: D, 13C, 15N, 18O
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    STEROIDS DEVELOPMENT

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    Sai Life Sciences has experience across a wide range of chemistries - asymmetric synthesis, drug conjugates for ADCs, chiral pool synthesis, heterocycles, synthesis of steroids, nucleosides & nucleotides, peptides, etc.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Steroid / Hormone
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    CDMO FOR PEPTIDE API DEVELOPMENT

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    Sai Life Sciences is a CDMO that offers peptide development and peptide synthesis services. It provides custom peptide synthesis, peptide API development, peptide API manufacturing, peptide drug development along with other custom peptide services.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Protein / Peptide
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    DRUG METABOLISM AND PHARMACOKINETICS

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    Sai Life Sciences has been a trusted partner for delivering high-quality In Vitro ADME services to a broad range of innovator clients.

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    Pharma Service: Clinical Trials

    Category: Early Clinical / Phase I-IIa

    Sub Category: Pharmacokinetics / Pharmacodynamics / Pharmacometrics
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