CDMO And CMO – smilax Labs

CDMO & CMO

Smilax provides custom research and contract manufacturing services of APIs and intermediates for global companies, covering a wide range of therapeutic areas.

Contract Development and Manufacturing Organization (CDMO)

Smilax provides comprehensive services that span the entire drug development lifecycle, including R&D, process optimization, trial batch manufacturing, and commercial-scale production. We provide cost-saving and faster time-to-market by streamlining development, regulatory support, and manufacturing under one roof.

Services Offered:

Process Development: Development and optimization of API synthesis routes, including scale-up capabilities
Analytical Development: Method development, validation, and stability testing for APIs.
Regulatory Support: Assistance with regulatory documentation (DMF, CMC sections) and compliance with regulatory bodies like FDA, EMA, etc.
Technology Transfer: Transferring processes from R&D to manufacturing at a commercial scale for both in-licensing and out-licensing
Commercial Manufacturing: Supply of APIs for full-scale commercial production

Capabilities & Infrastructure:

Well-equipped R&D Centre with 60+ Scientists
We carry out conventional chemical reactions like Catalytic Hydrogenations, Cyanation, Grignard, Halogenations, Nitrations, Friedel-Krafts and Specialized chemical reactions based on customer requirements.
We have expertise in process development and optimization, enabling cost-effective and scalable solutions.
Our facilities are equipped with cGMP compliance for handling and producing APIs
We have flexibility in batch sizes, from pilot-scale to commercial volumes.
Advanced technologies like continuous manufacturing, high-potency API production, and multimodal production capabilities.
Strong global presence with facilities strategically located for easy access to markets and regulatory agencies

Contract Manufacturing Organization (CMO)

Smilax provides the expertise and infrastructure to manufacture APIs from trial batches to commercial production. We offer cost-effective manufacturing services and bring speed and expertise in scaling up production, ensuring a reliable supply of APIs.

Services Offered:

API Manufacturing: small and large-scale production of APIs under cGMP conditions
Scale-Up & Process Optimization: Taking lab-scale processes to commercial scale while ensuring quality, efficiency, and cost-effectiveness
Regulatory Support: Ensuring production meets regulatory standards, including handling of regulatory audits and inspections

Capabilities & Infrastructure:

We have expertise in small-volume and high-volume commercial manufacturing, meeting cGMP requirements.
Our manufacturing facilities are capable of producing APIs in compliance with global regulatory standards.
We can manufacture a wide range of chemical entities, including small molecules and complex APIs

CDMO & CMO

Contract Development and Manufacturing Organization (CDMO)

Services Offered:

Process Development: Development and optimization of API synthesis routes, including scale-up capabilities

Analytical Development: Method development, validation, and stability testing for APIs.

Regulatory Support: Assistance with regulatory documentation (DMF, CMC sections) and compliance with regulatory bodies like FDA, EMA, etc.

Technology Transfer: Transferring processes from R&D to manufacturing at a commercial scale for both in-licensing and out-licensing

Commercial Manufacturing: Supply of APIs for full-scale commercial production

Capabilities & Infrastructure:

Well-equipped R&D Centre with 60+ Scientists

We carry out conventional chemical reactions like Catalytic Hydrogenations, Cyanation, Grignard, Halogenations, Nitrations, Friedel-Krafts and Specialized chemical reactions based on customer requirements.

We have expertise in process development and optimization, enabling cost-effective and scalable solutions.

Our facilities are equipped with cGMP compliance for handling and producing APIs

We have flexibility in batch sizes, from pilot-scale to commercial volumes.

Advanced technologies like continuous manufacturing, high-potency API production, and multimodal production capabilities.

Strong global presence with facilities strategically located for easy access to markets and regulatory agencies

Contract Manufacturing Organization (CMO)

Services Offered:

API Manufacturing: small and large-scale production of APIs under cGMP conditions

Scale-Up & Process Optimization: Taking lab-scale processes to commercial scale while ensuring quality, efficiency, and cost-effectiveness

Regulatory Support: Ensuring production meets regulatory standards, including handling of regulatory audits and inspections

Capabilities & Infrastructure:

We have expertise in small-volume and high-volume commercial manufacturing, meeting cGMP requirements.

Our manufacturing facilities are capable of producing APIs in compliance with global regulatory standards.

We can manufacture a wide range of chemical entities, including small molecules and complex APIs

Useful Links

Corporate Office

Registered Office