Mithra CDMO

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COMMERCIAL MANUFACTURING FOR STERILE INJECTABLES

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Our team combines expertise in drug development & formulation for generic applications or new chemical entities with an understanding of commercial contract manufacturing processes for long acting forms, sterile injectables and hormonal tablets.

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Pharma Service: Drug Product Manufacturing

Category: Injectable / Parenteral

Sub Category: Overview

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FULL POLYMER CHARACTERIZATION BY DSC

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The Mithra CDMO open platform is accessible to partners willing to leverage our technological know-how and capabilities across the drug life-cycle from proof of concept to commercialization.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: DSC

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FULL POLYMER CHARACTERIZATION BY RAMAN SPECTROSCOPY

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The Mithra CDMO open platform is accessible to partners willing to leverage our technological know-how and capabilities across the drug life-cycle from proof of concept to commercialization.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Raman

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DRUG DISSOLUTION & DIFFUSION STUDIES

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The Mithra CDMO open platform is accessible to partners willing to leverage our technological know-how and capabilities across the drug life-cycle from proof of concept to commercialization.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Dissolution

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PARTICLE SIZE DISTRIBUTION

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The Mithra CDMO open platform is accessible to partners willing to leverage our technological know-how and capabilities across the drug life-cycle from proof of concept to commercialization.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Particle Size

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PRODUCT LIFE CYCLE SCALABILITY

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Product life cycle scalability of formulations (early pilot studies, clinical trial materials, commercial batches), technical transferability are assured at all times thanks to a seamless collaboration between Mithra's development & manufacturing teams.

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Pharma Service: API & Drug Product Development

Category: Formulation Development

Sub Category: Scale-Up Capabilities

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TECHNOLOGY TRANSFERS IN CLINICAL SUPPLY

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Product life cycle scalability of formulations (early pilot studies, clinical trial materials, commercial batches), technical transferability are assured at all times thanks to a seamless collaboration between our development and manufacturing teams all on one site.

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Pharma Service: API & Drug Product Development

Category: Formulation Development

Sub Category: Tech Transfer

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DEVELOPMENT & VALIDATION OF DIFFUSION PROFILES

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By Complying major guidelines and pharmacopeias (ICH, EMA, FDA, USP, EP), Our mission is to develop and validate reliable methods analytical methods for drug substances, excipients, drug products, raw materials and cleaning methods and diffusion profiles adapted to formulation.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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ICH Q3B COMPLIANT STABILITY OR FORCED DEGRADATION STUDI...

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We offer stability testing under International Conference on Harmonization (ICH) conditions and custom conditions, Which includes bulk holding time, Freeze/thaw studies, Informal, formal, accelerated and long-term stability conditions & ICH or custom conditions.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

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UPLC H-CLASS WITH PDA DETECTOR

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The Mithra CDMO open platform is accessible to partners willing to leverage our technological know-how and capabilities across the drug life-cycle from proof of concept to commercialization.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Chromatography (TLC / LC / HPLC / UPLC / GC)

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UV SPECTROPHOTOMETER

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The Mithra CDMO open platform is accessible to partners willing to leverage our technological know-how and capabilities across the drug life-cycle from proof of concept to commercialization.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: UV Spectrophotometry

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GC-FID / HEADSPACE

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The Mithra CDMO open platform is accessible to partners willing to leverage our technological know-how and capabilities across the drug life-cycle from proof of concept to commercialization.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Chromatography (TLC / LC / HPLC / UPLC / GC)

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MICROBIOLOGICAL ANALYTICAL METHOD DEVELOPMENT & VALIDAT...

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The microbiology laboratory offers a complete range of services from microbiological analytical method development and validation to routine testing for the product, raw materials and components release.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Microbiology

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WATER QUALIFICATION & ROUTINE TESTING

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The microbiological laboratory will provide a range of testing complied with USP and EP requirements.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Pharmaceutical Water

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BACTERIAL ENDOTOXIN TESTING

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The microbiological laboratory will provide a range of testing complied with USP and EP requirements.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Microbiology

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CONTAINER CLOSURE INTEGRITY TESTING

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The microbiological laboratory will provide a range of testing complied with USP and EP requirements.

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Pharma Service: Analytical

Category: Container Closure Integrity

Sub Category: Assessment Programs

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BIOLOGICAL INDICATOR TESTING

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The microbiological laboratory will provide a range of testing complied with USP and EP requirements.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Microbiology

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Pharma Services Category of Mithra CDMO