API Process Development & CRAMS

We are an ideal Contract Partner for your API Process Development

We are inspected and Health Department approved, and provide integrated process development, API manufacturing at a single location. We have all the expertise required for developing a process that is robust, transferable, and scalable to meet your requirements.

We bring 30 years of experience to every project and deliver fully integrated solutions with an emphasis on quality, speed, and flexibility.

Our Contract Services include:

Lead Identification
Synthetic Route Development
Feasibility Studies
Process Parameterization Optimization
Scale-up Troubleshooting
Engineering Batches
WHO-GMP & cGMP-API Manufacturing

Process Development & Manufacturing Services

01.

Optimization of existing synthetic routes

02.

Development of GMP friendly alternative synthetic routes

03.

Development of IP protected synthetic routes

04.

Statistical Design of Experiments (DoE) for process parameterization and optimization

05.

Development and optimization of purification and isolation methods

06.

Transfer of process into GMP

07.

Troubleshooting

08.

Polymorphism Study

Drug Development

Our integrated Drug Development Services are designed to reduce your costs and timelines, helping you meet your drug discovery milestones.

This enables us to efficiently create molecules to your specifications in our fully equipped Custom Synthesis laboratories. In addition, our process chemistry experts can optimize your process and scale-up in accordance with your requirements for API manufacturing.

Our drug development services are supported by integrated Analytical Services, cGMP API Synthesis, preparation of standards. Our mission is to be a responsible and reliable drug discovery contract research partner throughout your project. We can accelerate your drug discovery and development program by integrating process development and API manufacturing all at a single location.

Our Drug Development Services include:

Synthetic Feasibility
Scale-up and Process Development
Lead Optimization
Drug Analog Synthesis
Structure Activity Optimization
Route Development
Medicinal Chemistry Research
CRAMS

Our in-house capacity can provide process development & optimization of the synthesis route and prepare the batch for pilot plant and bulk manufacturing in our WHO-GMP facility.

We have also engaged with third party manufacturer having WHO-GMP approved facility for contract manufacturing of the products under strict confidentiality agreement.

The Technology transfer will be done to the manufacturing plant while maintaining the secrecy & confidentiality of the client and product.

Chemistry Expertise

You may please send us your enquiries for the requirement of small scale to bulk production of Intermediates & Chemicals enabling us to quote competitive price & lead time. We are ready to share our scientific knowledge with your technical team and collaborate with you for any new product development phase. We would be highly obliged to be your preferred business partners and keen to have long term & trusted relationship.

  • Alkylation
  • Asymmetric Catalytic Hydrogenation
  • Asymmetric Ketone Reduction
  • Boronic Acid Chemistry
  • Halogenations
  • Catalytic Hydrogenation
  • Chemical Resolution
  • Chiral Synthesis
  • Condensation
  • Oxidation
  • Reduction
  • Diazotization
  • Friedel – Crafts
  • Grignard Reaction
  • Heterocyclic Ring Formation
  • Hoffman Rearrangement
  • Indole Synthesis
  • Isocyanate Synthesis
  • Carbohydrate Chemistry
  • Cyanide Reaction
  • Phase Transfer Reaction
  • Pyridine Chemistry
  • Pyrimidine Synthesis
  • Reductions – BH3, NaBH4, DIBAL
  • Ring Close
  • Suzuki Coupling
  • Swern Oxidation
  • Vilsmeier Reaction
  • Wittig Reaction

We Synthesize Customised Molecules for your Niche Segments & Scalability Improvements

Custom synthesis is the process where a molecule is made exclusively for a particular client according to specifications at their scale. It is one of the options available for pharmaceutical companies requiring active pharmaceutical ingredients (APIs), intermediates, fine chemicals, reference standards, impurities or metabolites needed to launch their research and development projects. Custom synthesis is essential to the pharmaceutical companies since many of these compounds can sometimes be very difficult to find or hard to synthesize.

Custom synthesis provides the platform necessary for clients’ to accelerate their projects to market.

Reliance Rasayan Custom Synthesis and Fine Chemical services offers a wide range of experience in the synthesis of low volume, high value small molecules for biotechnology and pharmaceutical applications. With services available in vessels up to 350L in size and R&D and cGMP environments, Reliance Rasayan can meet your custom synthesis and fine chemicals requirement.

Active Pharmaceutical Ingredients
Pharmaceutical Intermediates
Drug Analogs
Drug Metabolites
Reference Standards
Pharmaceutical Impurities
Chemical Intermediates