Hapto Pharmaceuticals Contract Manufacturing

Contract Manufacturing

Comprehensive Pharmaceutical Manufacturing Solutions

Structured contract manufacturing solutions across APIs, intermediates, KSMs, and finished formulations with chemo-enzymatic process expertise.

What We Manufacture

Manufacturing Scope

APIs

Active Pharmaceutical Ingredients

Intermediates & KSMs

Key Starting Materials & Chemical Intermediates

Finished Formulations

Complete dosage form manufacturing

Special Expertise

Chemo-Enzymatic Process Development & Commercialization

Hapto Pharmaceuticals is a specialist in Chemo-Enzymatic Process Development and Commercialization, combining synthetic chemistry with biocatalysis to achieve superior process outcomes.

Higher enantioselectivity
Improved yield efficiency
Reduced impurity profiles
Environmentally sustainable processing
Lower solvent consumption
Cost-optimized manufacturing

Our Chemo-Enzymatic Capabilities

1

Enzyme screening & optimization

2

Reaction pathway redesign

3

Process intensification

4

Scale-up from R&D to Plant

5

Enzyme-protected supply chains

6

Integration into cGMP manufacturing

7

Validation batch execution

We maintain collaborations with leading enzyme technology companies

Advanced Enzymes Technologies
Codexis
Novozymes

This positions Hapto as a high-value, advanced API development partner — not just a conventional manufacturer.

Execution Model

Manufacturing Execution Model

1

R&D Scale Validation

Laboratory process validation and feasibility

2

Pilot Plant Demonstration

Scale-up testing at pilot plant level

3

Three Validation Batches

Process validation and consistency

4

Commercial Scale Manufacturing

Full-scale commercial production

5

Vendor Qualification

Supplier assessment and approval

6

Regulatory Documentation

Complete filing support and documentation

7

Customer Audit Readiness

Preparation for third-party audits

8

Lifecycle Process Optimization

Continuous improvement and optimization

Quality & Compliance

Regulatory & Quality Alignment

Our leadership experience aligns with global standards, ensuring your products meet the highest quality and regulatory requirements worldwide.

US FDA

United States

EMA

European Union

SFDA

Saudi Arabia

PMDA

Japan

Leadership exposure includes:

Aurobindo Pharma Sai Life Sciences Sun Pharma Dr. Reddy's Laboratories

Interested in Contract Manufacturing?

Reach out to discuss API development, chemo-enzymatic process capabilities, or custom manufacturing partnerships.

Get in Touch