Formulation Development and Analytical services

Suven Pharma provides powerful formulation development services to support the development of chemistry for your pipelines without having experience in manufacturing. Our expert team develop stable and compliant formulations for right API and the best dosage forms.

We have experience formulating a

Variety of dosage forms:

Solid Orals

Tablets, Capsules, Films, Tablet in Capsule

Liquid Orals

Solutions, Suspensions, Emulsions, Syrups

Topical Liquids

Solutions, Lotions

Semi-solids

Ointments, Creams, Gels

Injections

Solutions, Suspensions, Depots

Sachets

Wet non-woven cloth, Powders

Nano Tech Products

Suspensions, Ointments, Creams

Inserts

Suppositories, Pessaries

Highlights

of our formulation development services:

Formulation Development Laboratories

Dedicated and Customized Laboratories for Formulation Development

Technology Laboratories for New Drug Delivery Systems Development

Process Development Laboratories

Packaging Development and Testing Laboratories

cGMP Scale-up& Manufacturing of Exhibit, Clinical & Commercial Supply facilities

Analytical Method Development & Validation Laboratories

Microbiology Testing Laboratory

Stability Chambers

Warehouse

NCEs Formulation Development

Suven Pharma solves early-stage formulation challenges for NCE product candidates in Phase I or Phase II and accelerate the go to market with powerful formulation solutions and pipeline possibilities. Our manufacturing capabilities for NCEs includes Real-time formulation development support for adaptive clinical trials and reduced production costs with novel dosage forms that minimize R&D iteration.  At Suven Pharma we focus on making the chemistry stable , safe, and developing effective dosage form for patient administration in the drug development process.

NCEs formulation development services

Offered by Suven Pharma includes :

Pre-formulation studies:

The team conducts pre-formulation studies to determine the physicochemical properties of the drug substance, including solubility, stability, and compatibility with excipients.

Formulation development

We develop formulations for a wide range of dosage forms, including solid orals , liquid orals, topical liquids, semi-solids, injections, sachets and Nano Tech Products. Suven pharma can help optimizing the formulation to enhance drug delivery, bioavailability, and stability.

Analytical method development

We develop and validate analytical methods to measure the drug substance and product's quality attributes and ensure regulatory compliance.

Process development

We develop and optimize the manufacturing process to ensure consistent product quality, minimize manufacturing costs, and improve efficiency.

Scale-up and technology transfer

We help our partners to scale-up the manufacturing process from lab to pilot scale and transfer the technology to commercial-scale manufacturing.

Regulatory support

With our 33 + years’ experience of working with innovators and regulate market partners, we offer regulatory support and guidance ensuring compliance with the regulatory requirements of various regulatory agencies including US FDA and EMA.

Bringing bring safe, effective, and stable

Drug products to market

Services includes:

Early Formulation Development

Clinical Product Development

Scale-up and Manufacturing of IND batches

Manufacturing and Packaging of Clinical Supplies ( Phase I-III)

Placebo Manufacture

Comparator Product Modifications

Multi-Product Packing

Kit Assembly

Analytical services

Suven Pharma analytical services includes the usage of analytical methods to evaluate the quality, safety, and efficacy of chemistry of drug throughout the development and manufacturing process of the products.

Our broad range of analytical services enables our partners to launch high-quality drug products.

Overall, analytical services are critical to ensuring the quality, safety, and efficacy of drug products. CDMOs offer a broad range of analytical services, enabling pharmaceutical and biotechnology companies to bring high-quality drug products to commercialization.

Microbiology Laboratory Instruments

Horizontal Laminar Air Flow Benches (2No’s)

Vertical Laminar Air Flow (1No’s)

Incubators (2000 lts)

Cooling Incubator 2 to 8 °C (400 liters)

Ultra Low Cooling Cabinet -20 to -40 °C (400 lts)

Autoclave (Single door & Double door)

Antibiotic Zone Reader

Colony Counter

Biosafety Cabinet (Class-IIB2)

Carl Zeisis Microscope

Ensuring the

Quality, Safety, and Efficacy of Drug Products

Method development and validation:

We develop and validate analytical methods include chromatography, spectroscopy, mass spectrometry, and other techniques to measure the quality attributes of drug substances and products.

Stability testing:

Stability testing to evaluate the shelf-life of drug products under various storage conditions.

Impurity analysis:

Impurity analysis identify and quantify impurities and degradation products in drug substances and products using analytical methods.

Release testing:

Release testing to ensure that drug products meet the required quality standards before they are released for distribution.

Microbiological testing:

Microbiological testing to ensure that drug products are free from microbial contamination and meet the required standards.

Analytical method transfer:

We help transferring analytical methods from one laboratory to another, ensuring consistency in the results obtained.