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Pharma Services Category of Stason Pharmaceuticals, Inc.

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API Development

Analytical Method Development

Analytical Testing Services

Biologic Drugs

Capsule

Clinical Services

Container Qualification

Contract Services

Custom Synthesis & Manufacturing

Formulation Development

High Potency APIs (HPAPIs)

Liquid

Packaging and Distribution Testing

Preformulation & Material Science

Scale Up

Serialization Software

Stability Studies

Tablet

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Stason Pharmaceuticals, Inc.

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UNITED STATES

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Custom Manufacturing

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- Service Details

Offers API synthesis that includes custom manufacturing of organic molecules from milligram to kg quantities. Also develops new processes for the synthesis of target molecules, including biotransformation processes for the preparation of chiral molecules.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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API Synthesis

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- Service Details

Offers API synthesis that includes custom manufacturing of organic molecules from milligram to kg quantities. Also develops new processes for the synthesis of target molecules, including biotransformation processes for the preparation of chiral molecules.

- Directory Listing

Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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Drug Development

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- Service Details

Offers API synthesis that includes custom manufacturing of organic molecules from milligram to kg quantities. Also develops new processes for the synthesis of target molecules, including biotransformation processes for the preparation of chiral molecules.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Biocatalysis

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Polymorphism

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- Service Details

Characterization studies for your product can be conducted prior to formulation.We specialize in the design and execution of pertinent pre-formulation activities required for successful pharmaceutical product development.

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Pharma Service: API & Drug Product Development

Category: Preformulation & Material Science

Sub Category: Polymorph & Crystal Screening

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Excipient-Excipient Compatibility

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- Service Details

Characterization studies for your product can be conducted prior to formulation.We specialize in the design and execution of pertinent pre-formulation activities required for successful pharmaceutical product development.

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Pharma Service: API & Drug Product Development

Category: Preformulation & Material Science

Sub Category: Excipient Screening

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API-Excipient Interaction Studies

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- Service Details

Characterization studies for your product can be conducted prior to formulation.We specialize in the design and execution of pertinent pre-formulation activities required for successful pharmaceutical product development.

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Pharma Service: API & Drug Product Development

Category: Preformulation & Material Science

Sub Category: Salt Screening

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pKa/Log P Determination

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- Service Details

Characterization studies for your product can be conducted prior to formulation.We specialize in the design and execution of pertinent pre-formulation activities required for successful pharmaceutical product development.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: pKa and LogP

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Hygroscopicity Studies

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- Service Details

Characterization studies for your product can be conducted prior to formulation. We specialize in the design and execution of pertinent pre-formulation activities required for successful pharmaceutical product development.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Sorption and Desorption

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Phase Solubility Determination

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- Service Details

Characterization studies for your product can be conducted prior to formulation. We specialize in the design and execution of pertinent pre-formulation activities required for successful pharmaceutical product development.

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Photostability of API

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- Service Details

Characterization studies for your product can be conducted prior to formulation. We specialize in the design and execution of pertinent pre-formulation activities required for successful pharmaceutical product development.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Photostability

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Degradation Pathway Determination

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- Service Details

Characterization studies for your product can be conducted prior to formulation. We specialize in the design and execution of pertinent pre-formulation activities required for successful pharmaceutical product development.

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Pharma Service: Analytical

Category: Packaging and Distribution Testing

Sub Category: Shelf Life and Accelerated Aging Testing

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Matrix Stability Evaluations

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- Service Details

Characterization studies for your product can be conducted prior to formulation. We specialize in the design and execution of pertinent pre-formulation activities required for successful pharmaceutical product development.

- Directory Listing

Pharma Service: Analytical

Category: Stability Studies

Sub Category: Photostability

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Container-API Interactions

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- Service Details

Characterization studies for your product can be conducted prior to formulation. We specialize in the design and execution of pertinent pre-formulation activities required for successful pharmaceutical product development.

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Pharma Service: Analytical

Category: Container Qualification

Sub Category: Testing Services

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Particle Size/Solubility Studies

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- Service Details

Characterization studies for your product can be conducted prior to formulation. We specialize in the design and execution of pertinent pre-formulation activities required for successful pharmaceutical product development.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Particle size

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Method Development & Validation

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- Service Details

Analytical methods are essential to both the pharmaceutical development process and the evaluation of drug product to meet the standard of potency, purity and stability. We also have a DEA analytical permit for CII-CIV products.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Identity, Quantitation, Potency, Content Unif...

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- Service Details

Analytical methods are essential to both the pharmaceutical development process and the evaluation of drug product to meet the standard of potency, purity and stability. We also have a DEA analytical permit for CII-CIV products.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Content Uniformity / Homogeneity

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Lot Release & Stability Assessment

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- Service Details

Analytical methods are essential to both the pharmaceutical development process and the evaluation of drug product to meet the standard of potency, purity and stability. We also have a DEA analytical permit for CII-CIV products.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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Pre-Formulation Solubility & Stability Evalua...

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- Service Details

Comprehensive evaluation of drug candidates during pre-formulation is critical to the formulation development process. Specific challenges include low bioavailability, poor solubility and/or permeability, and poor physical stability.

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Excipient Screening

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- Service Details

Comprehensive evaluation of drug candidates during pre-formulation is critical to the formulation development process. Specific challenges include low bioavailability, poor solubility and/or permeability, and poor physical stability.

- Directory Listing

Pharma Service: API & Drug Product Development

Category: Preformulation & Material Science

Sub Category: Excipient Screening

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Formulation Optimization & Finalization

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- Service Details

Comprehensive evaluation of drug candidates during pre-formulation is critical to the formulation development process. Specific challenges include low bioavailability, poor solubility and/or permeability, and poor physical stability.

- Directory Listing

Pharma Service: API & Drug Product Development

Category: Formulation Development

Sub Category: Process Development & Optimization

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Scale Up

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- Service Details

We will develop cost-efficient strategies to ensure the acceptability of scale-up & post-approval changes, long-term stability commitment on post-change batches for NDAs & ANDAs—per 21 CFR 314.70 & other changes to an approved application.

- Directory Listing

Pharma Service: API Manufacturing

Category: Scale Up

Sub Category: Overview

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High Containment Operations

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- Service Details

Our analytical testing labs are furnished with appropriate equipment such as safety workbenches for sample preparations, containment hoods and isolators for testing samples, and separation from the normal lab areas and with limited access.

- Directory Listing

Pharma Service: API Manufacturing

Category: High Potency APIs (HPAPIs)

Sub Category: Overview

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QC Testing & Stability Monitoring

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- Service Details

Stason has quality control systems, which require strict adherence to cGMP regulations. Total system quality is monitored from sample receipt to report generation. Offers QC testing for API’s, pharmaceutical intermediates, excipients & finished products.

- Directory Listing

Pharma Service: Analytical

Category: Stability Studies

Sub Category: Photostability

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Blister

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- Service Details

Offers the ability to package solid, and semi solid non sterile and sterile dosage forms into a variety of packages including bulk, bottle, or blister. Multiple automatic and semi-automated packaging lines are used for clinical and commercial packaging.

- Directory Listing

Pharma Service: Packaging

Category: Contract Services

Sub Category: Blister

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Bottles

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- Service Details

Offers the ability to package solid, and semi solid non sterile and sterile dosage forms into a variety of packages including bulk, bottle, or blister. Multiple automatic and semi-automated packaging lines are used for clinical and commercial packaging.

- Directory Listing

Pharma Service: Packaging

Category: Contract Services

Sub Category: Bottle

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Clinical Packaging- Bottles

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- Service Details

Offers the ability to package solid, and semi solid non sterile and sterile dosage forms into a variety of packages including bulk, bottle, or blister. Multiple automatic and semi-automated packaging lines are used for clinical and commercial packaging.

- Directory Listing

Pharma Service: Packaging

Category: Clinical Services

Sub Category: Bottle

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Clinical Packaging-Blister

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- Service Details

Offers the ability to package solid, and semi solid non sterile and sterile dosage forms into a variety of packages including bulk, bottle, or blister. Multiple automatic and semi-automated packaging lines are used for clinical and commercial packaging.

- Directory Listing

Pharma Service: Packaging

Category: Clinical Services

Sub Category: Blister

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Serialization

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- Service Details

Stason's provides automated printing and inspecting of DSCSA compliant human readable bar codes for bottle labels and cartons. The units have the capability to be aggregated on an inner case, shipper case, and pallet level (4 levels of aggregation).

- Directory Listing

Pharma Service: Packaging

Category: Serialization Software

Sub Category: Full Suite / Overview

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High Potent Biological Drugs Manufacturing

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- Service Details

Stason has capabilities to manufacture high potent biological drugs.

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Pharma Service: Drug Product Manufacturing

Category: Biologic Drugs

Sub Category: High Potent

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High Potency API Tablets Manufacturing

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- Service Details

Stason has capabilities to manufacture high potency APIs tablets.

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Pharma Service: Drug Product Manufacturing

Category: Tablet

Sub Category: High Potency APIs (HPAPIs)

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High Potency API Capsules Manufacturing

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- Service Details

Stason has capabilities to manufacture high potency APIs capsules.

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Pharma Service: Drug Product Manufacturing

Category: Capsule

Sub Category: High Potency APIs (HPAPIs)

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High Potency API Injectables Manufacturing

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- Service Details

Stason has capabilities to manufacture high potency APIs injectables.

- Directory Listing

Pharma Service: Drug Product Manufacturing

Category: Liquid

Sub Category: High Potency APIs (HPAPIs)

Pharma Services Category of Stason Pharmaceuticals, Inc.

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