API Research and Development

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Research & Development (R&D)

At Cerata Pharmaceuticals LLP, Research and Development is the foundation of our API manufacturing excellence. Our R&D capabilities support the complete API lifecycle—from early process development and route optimization to scale-up, validation, and commercial manufacturing—ensuring consistent quality, regulatory readiness, and reliable global supply of Steroid, Hormone, Oncology, and Peptide APIs.

Our R&D function serves as a critical bridge between laboratory innovation and robust GMP manufacturing, enabling smooth technology transfer and predictable scale-up.

With two advanced API R&D facilities located in Gujarat, India, Cerata has established itself as a trusted development and manufacturing partner for Steroid, Hormone, Oncology, and Peptide APIs. Our experienced and highly qualified scientists combine strong chemical expertise with strong manufacturing insight to deliver scalable, cost-effective, and sustainable processes for long term commercial API supply.

Advanced R&D Facilities

R&D Infrastructure & Scientific Strength

Cerata operates dedicated API R&D facilities in Gujarat, India, staffed by experienced scientists with strong academic backgrounds and extensive industry exposure. Our teams work across chemistry, analytical development, and process engineering to ensure seamless translation of laboratory innovation into commercial production.

Dedicated Laboratories

Dedicated R&D laboratories aligned with manufacturing operations

Bench-to-Plant Integration

Strong bench-to-plant integration for predictable scale-up

Expert Scientists

Experienced scientists with expertise in complex and hazardous chemistries

Continuous Enhancement

Continuous skill enhancement through exposure to evolving technologies and methodologies

Core R&D Capabilities

Our R&D activities cover the complete lifecycle of API development, with a focus on efficiency, reproducibility and regulatory-compliance manufacturing processes aligned with commercial objectives.

Process Development

Process development and route optimization for complex APIs

Pathway Selection

Selection of optimal synthetic and biotransformation pathways

Yield Improvement

Yield improvement and impurity control strategies

Scale-up

Scale-up from lab to pilot and commercial manufacturing

Process Validation

Process validation and technology transfer to our GMP certified manufacturing Units

Process Development & Manufacturing Integration

Our R&D teams focus on developing efficient, safe, and cost-effective processes that remain robust throughout the product lifecycle. Processes developed at laboratory scale are systematically evaluated, optimized, and scaled up to commercial production under controlled conditions.

Key Activities Include:

Generic API Development

Development of generic APIs, intermediates, and custom synthesis products

Route Scouting

Route scouting and process research for complex and high-value molecules

Alternate Routes

Development of non-infringing and alternate synthetic routes

Troubleshooting Support

Troubleshooting support to manufacturing plants

Technical Support

Technical support to Quality Assurance and Regulatory Affairs teams

Expertise in Complex & Hazardous Chemistry

Cerata's R&D teams are experienced in handling complex, sensitive, and hazardous chemical reactions, which are developed at R&D scale and safely executed at commercial scale.

Our Chemistry Expertise Includes:

  • Multi-step organic synthesis and advanced reaction engineering
  • Handling of sensitive, high-energy, and controlled reactions
  • Optimization of reaction conditions for safety, yield, and cost efficiency
  • Mechanism-based process development with rigorous parameter screening

Each process undergoes systematic optimization covering solvent selection, reagent efficiency, reaction kinetics, safety, utility consumption, and raw material economics before validation and commercialization.

Fermentation & Bioconversion R&D (Steroid & Hormone APIs)

  • Microbial and enzymatic biotransformation development
  • Hydroxylation, oxidation, and stereoselective conversions
  • Media optimization and fermentation parameter control
  • Scale-up strategies from lab fermenters to production scale
  • Integration of bioconversion with chemical synthesis routes

Specialized R&D Areas

Steroid & Hormone API Development

Steroid and Hormone API development requires precise control over stereochemistry, isomer ratios, and impurity profiles.

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Oncology API Development

Oncology API Research & Development is built around safety, containment, precision, and reproducibility.

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Peptide API Development

Specialized Peptide API R&D focused on sequence fidelity, molecular accuracy, and scalable synthesis.

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Steroid & Hormone API Development

Steroid and Hormone API development requires precise control over stereochemistry, isomer ratios, and impurity profiles. Cerata's R&D capabilities are designed to deliver robust, scalable, and regulatory-compliant processes for endocrine-active molecules.

Steroid API Route Optimization

A multi-step steroid synthesis was redesigned using bioconversion-based hydroxylation, reducing chemical steps, lowering impurity formation, and improving overall yield while maintaining stereochemical integrity.

Core R&D Capabilities

Route optimization for complex multi-step synthesis
Control of stereochemistry and isomer ratios
Fermentation and biotransformation route development
Impurity profiling and purge strategy design
Crystallization and polymorph control

R&D to Manufacturing Integration

Predictable scale-up and validation
Consistent batch quality
Long-term commercial reproducibility

Oncology API Development

At Cerata Pharmaceuticals LLP, Oncology API Research & Development is built around safety, containment, precision, and reproducibility.

Our oncology R&D capabilities are designed to support the development and commercial manufacturing of high-potency, cytotoxic, and low-dose APIs, fully aligned with global regulatory expectations.

Oncology API Scale-Up

A high-potency oncology API was successfully scaled from gram-level R&D batches to GMP manufacturing with controlled impurity profiles, validated containment strategies, and consistent batch reproducibility under low OEL conditions.

Core Oncology R&D Capabilities

Development of high-potency and cytotoxic APIs
Containment-compatible and OEL-driven process design
Genotoxic impurity (GTI) identification, control, and purge strategies
Trace-level impurity profiling and control
Safe scale-up strategies for cytotoxic compounds

Process Development & Safety Engineering

Oncology processes are developed using risk-based and containment-driven design principles.

  • Mechanism-based route selection and optimization
  • Selection of safer reagents and controlled reaction conditions
  • Evaluation of heat, pressure, toxicity, and exposure risks
  • Design of scalable processes compatible with containment systems
  • Cleaning validation and cross-contamination control strategies

Peptide API Development

Cerata Pharmaceuticals LLP offers specialized Peptide API R&D focused on sequence fidelity, molecular accuracy, and scalable synthesis.

Our peptide R&D capabilities support the full lifecycle—from early SPPS development to commercial GMP manufacturing.

Peptide API Commercialization

A complex peptide developed using SPPS was optimized for higher yield and reduced deletion impurities, followed by seamless technology transfer to commercial manufacturing with stable quality performance.

Peptide R&D Capabilities

Solid-Phase Peptide Synthesis (SPPS) route development
Protective group and coupling strategy optimization
Control of deletion, truncation, and aggregation impurities
Yield enhancement and impurity reduction strategies
Transition from R&D synthesis to commercial scale

Process Optimization & Scale-Up

Resin Selection

Resin selection and loading optimization

Coupling Efficiency

Coupling efficiency and deprotection control

Purification Strategies

Scalable cleavage and purification strategies

Lyophilization

Lyophilization process development

R&D Laboratory Infrastructure & Equipment

Our R&D laboratories are designed to simulate commercial manufacturing conditions, ensuring smooth and risk-controlled scale-up.

Chemistry & Process Development Labs

  • Glass reactors and SS reactors for multi-step synthesis
  • Temperature-controlled reaction systems
  • Hydrogenation and pressure reaction setups
  • Fermentation and bioconversion laboratory units
  • Containment-ready equipment for potent compounds

Peptide R&D Infrastructure

  • Automated peptide synthesizers (SPPS)
  • Controlled cleavage and purification systems
  • Lyophilization units for peptide intermediates
  • High-purity solvent handling systems

Analytical & Development Support

  • HPLC, UPLC, and GC systems for method development
  • LC-MS support for impurity and structure confirmation
  • Stability chambers for early-phase stability assessment
  • In-process analytical monitoring tools

Advanced Analytical Infrastructure

Analytical development plays a critical role in supporting robust API development and regulatory compliance. Cerata Pharmaceuticals LLP operates a fully equipped Analytical Development laboratory staffed by experienced and qualified scientists supporting R&D, manufacturing, and regulatory submissions across Steroid, Hormone, Oncology, and Peptide APIs.

Our Analytical R&D team works closely with process development and QC to ensure accurate characterization and reliable quality control throughout the product lifecycle.

Development and validation of stability-indicating analytical methods
Structural identification and characterization of APIs and intermediates
Impurity, by-product, and degradation profiling
Isolation and characterization of critical impurities
Analytical method transfer to Quality Control laboratories

Stability Studies

Stability testing is an integral part of our development and quality assurance strategy. All stability studies are conducted in accordance with ICH Q1 guidelines using qualified and continuously monitored stability chambers.

  • Long-term and accelerated stability studies
  • Ongoing stability monitoring for commercial APIs
  • Shelf-life establishment and regulatory support

Advanced Equipment Includes:

HPLC
GC
LC-MS
GC-MS
ICP-MS
NMR Spectroscopy
Flash Chromatography
Particle Size Analyzers

This comprehensive analytical infrastructure ensures accurate characterization, regulatory-ready documentation, and consistent product quality.

Quality by Design & Regulatory Readiness

R&D activities at Cerata are guided by Quality by Design (QbD) principles and risk-based development approaches aligned with global regulatory expectations.

CQA Control

Identification and control of critical quality attributes (CQAs)

ICH Guidelines

Development aligned with WHO-GMP, cGMP, and ICH guidelines

Regulatory Documentation

Regulatory-ready documentation to support DMF and global filings

Market Compliance

Regulatory-oriented process development for regulated markets

Audit Support

Support for regulatory queries, audits, and inspections

Scale-Up & Technology Transfer

Laboratory to Commercial Scale

Laboratory to pilot and commercial scale transition

Risk-Based Strategies

Risk-based scale-up strategies

Batch Reproducibility

Batch reproducibility and robustness studies

Technology Transfer

Technology transfer documentation and execution

Team Collaboration

Close collaboration with Manufacturing and QA teams

Sustainability & Safety

Environmental responsibility and operator safety are integral to process development.

Solvent Recovery

Solvent recovery and waste minimization strategies

Energy Efficiency

Energy-efficient and environmentally responsible process design

Safe Handling

Emphasis on safe handling of potent, cytotoxic, and low-dose compounds

Collaboration & Commercial Enablement

Our R&D teams work in close coordination with Manufacturing, QA, QC, and Regulatory functions to ensure smooth transition from development to commercial supply of API.

Seamless Transition

Seamless transition from R&D to commercial manufacturing

Customer-Focused

Customer-focused development and customization support

Accelerated Development

Accelerated development and scale-up strategies

Long-term Support

Long-term technical support across the product lifecycle

Our R&D Strength

API-focused R&D aligned with commercial manufacturing
Strong chemistry expertise across Steroid, Hormone, Oncology, and Peptide APIs
Integrated chemistry, fermentation, and analytical development
Regulatory-focused development with audit-ready documentation
Proven reproducibility from laboratory to commercial scale
Commitment to innovation, quality, and sustainable manufacturing

This integrated and science-driven R&D approach enables Cerata Pharmaceuticals LLP to deliver high-quality, scalable, and regulatory-compliant APIs, supporting global pharmaceutical partners from development through long-term commercial supply.