Pharmaceutical Contract Manufacturing Services

Frigate offers advanced pharmaceutical contract manufacturing with precision and compliance. We specialize in API synthesis, formulation, and scalable production for diverse therapeutic needs. 

Our Clients

Advantages of Pharmaceutical Contract Manufacturing Services

Advanced Technology

Pharmaceutical contract manufacturers utilize state-of-the-art equipment and automation to ensure precise control over production processes and enhance overall product quality.

Faster Time-to-Market

Contract manufacturing accelerates production timelines by leveraging existing infrastructure and expertise, allowing faster entry into competitive pharmaceutical markets.

Risk Mitigation

Outsourcing manufacturing reduces the risk of regulatory non-compliance, quality control issues, and production delays, thanks to the expertise of specialized manufacturers.

Process Validation

Contract manufacturers conduct rigorous process validation to confirm that each step in the production process meets predefined quality and performance standards.

Custom Pharmaceutical Contract Manufacturing

Custom pharmaceutical contract manufacturing offers precision in production, ensuring compliance with global standards and regulatory requirements. With expertise in API synthesis, formulation, and packaging, pharmaceutical needs are met efficiently and accurately. Advanced technologies and specialized facilities streamline processes, enabling scalable production to handle varying volumes. The focus on quality control and process validation ensures consistent product quality while flexible solutions adapt to market demands. Tailored manufacturing services ensure that each phase, from development to final packaging, is optimized for cost and performance. 

Pharmaceutical Contract Manufacturing Services

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Our Pharmaceutical Contract Manufacturing Process

Client Consultation and Product Specification

The process begins with detailed discussions to define product requirements, including formulation, dosage forms, and regulatory standards. 

Formulation Development

Experts develop the optimal formulation by selecting suitable ingredients, ensuring stability, bioavailability, and compliance with pharmacological standards. 

Process Design and Scale-Up

A scalable manufacturing process is designed with considerations for equipment, batch size, and process optimization to ensure efficiency in large-scale production. 

Regulatory Compliance and Validation

All processes and products undergo rigorous testing to meet regulatory guidelines (FDA, EMA, etc.), ensuring they are safe and market-ready. 

Manufacturing and Quality Control

The production phase involves strict quality control, where each batch is tested for consistency, potency, and purity according to predetermined specifications. 

Packaging and Distribution

Final products are packaged according to industry standards, ensuring safe handling and distribution. They are prepared for shipment to clients or directly to markets. 

Industries We Serve

Pharmaceutical Contract Manufacturing Services
Client Consultation and Product Specification

The process begins with detailed discussions to define product requirements, including formulation, dosage forms, and regulatory standards. 

Formulation Development

Experts develop the optimal formulation by selecting suitable ingredients, ensuring stability, bioavailability, and compliance with pharmacological standards. 

Process Design and Scale-Up

A scalable manufacturing process is designed with considerations for equipment, batch size, and process optimization to ensure efficiency in large-scale production. 

Regulatory Compliance and Validation

All processes and products undergo rigorous testing to meet regulatory guidelines (FDA, EMA, etc.), ensuring they are safe and market-ready. 

Manufacturing and Quality Control

The production phase involves strict quality control, where each batch is tested for consistency, potency, and purity according to predetermined specifications. 

Packaging and Distribution

Final products are packaged according to industry standards, ensuring safe handling and distribution. They are prepared for shipment to clients or directly to markets. 

Our Pharmaceutical Contract Manufacturing Process

Mitigating Compliance Risks Through Rigorous Process Control

Pharmaceutical manufacturing requires adherence to complex global regulations, including FDA, EMA, and ICH standards. Frigate ensures compliance by implementing robust quality systems, documentation, and validation processes throughout production. Every stage, from raw material sourcing to final product packaging, is monitored to meet these stringent requirements. This structured approach minimizes the risk of non-compliance and ensures that all products are safe, effective, and ready for market approval, reducing the potential for regulatory delays or recalls. 

Pharmaceutical Contract Manufacturing Services

Pharmaceutical Contract Manufacturing Materials

Pharmaceutical contract manufacturing requires precise control over production processes and quality. Each step must adhere to rigorous standards to ensure product consistency and safety. 

Active Pharmaceutical Ingredients (APIs)

APIs are biologically active substances that provide a therapeutic effect. These materials require precise synthesis, purification, and testing for potency, stability, and bioavailability. Techniques such as crystallization, chromatography, and drying ensure the highest purity levels. 

Excipients

Excipients serve as the vehicle for the API, aiding in the formulation's stability, release profile, and patient compliance. Common excipients include lactose (for tablet compression), hydroxypropyl methylcellulose (as a binder), and magnesium stearate (as a lubricant), all of which must meet stringent regulatory standards. 

Solvents

Solvents such as ethanol, methanol, and isopropyl alcohol are used in the extraction and purification. The selection of solvents is critical for achieving solubility without compromising API integrity, and they must comply with pharmacopeial standards for residual solvent limits. 

Polymers

Polymers, such as polyvinylpyrrolidone (PVP) and ethylcellulose, are used for tablet coatings or sustained-release formulations. Their molecular weight and solubility properties are carefully controlled to achieve desired release kinetics, whether for immediate or controlled release.

Coatings

Coating agents, such as hydroxypropyl methylcellulose (HPMC) and ethylcellulose, protect the API from degradation due to environmental factors. Enteric coatings, for example, use polymers that are insoluble in acidic environments but dissolve in the intestines, ensuring targeted drug delivery.

Packaging Materials

Primary packaging materials, such as polyethylene (PE) and polypropylene (PP) for bottles or aluminum for blister packs, are chosen based on the drug's sensitivity to light, moisture, and air. These materials must also meet regulatory standards for leachability and interaction with the drug formulation. 

Surfactants

Surfactants, like polysorbates and cetyl alcohol, enhance solubility and improve the bioavailability of poorly soluble drugs. They facilitate uniform mixing and prevent aggregation, ensuring consistent drug delivery and performance. 

Enhancing Biopharmaceutical Manufacturing with Scalable Contract Solutions

Biopharmaceutical companies often encounter difficulties managing complex production processes and maintaining stringent quality controls. Pharmaceutical contract manufacturing offers an efficient solution by providing specialized expertise in developing and producing biological components. With Frigate’s advanced technologies, such as automated filling systems, real-time quality monitoring, and precision formulation, manufacturers can ensure optimal performance and compliance with FDA and EMA standards. 

What You Gain with Us

We make your profitability and operations easier with practical approach.

Pharmaceutical Contract Manufacturing Services
Pharmaceutical Contract Manufacturing Services

↓ 7-8%

OPS COST

Pharmaceutical Contract Manufacturing Services

↓ 2-3%

COGM

Pharmaceutical Contract Manufacturing Services

3X

Aggregation

Pharmaceutical Contract Manufacturing Services

↑ 25%

Machinery Utilisation

Pharmaceutical Contract Manufacturing Services

↓ 50%

Expedition

Pharmaceutical Contract Manufacturing Services

↑ 30%

Frigater Revenue

Scaling Production Without Compromising Quality or Performance

Scaling production while maintaining consistent quality can be a challenge in pharmaceutical manufacturing. Frigate addresses this by employing optimized processes and advanced technologies that ensure uniformity across all production scales. Detailed validation protocols and real-time monitoring systems are used to maintain product integrity and consistency. This approach ensures that both small and large batches meet the same high standards for quality, bioavailability, and stability, facilitating smooth transitions between different production volumes without compromising product performance. 

Pharmaceutical Contract Manufacturing Services
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What Our Customers Say about Frigate

Pharmaceutical Contract Manufacturing Services

21%

Faster Manufacturing

Having Doubts? Our FAQ

Check all our Frequently Asked Question

How does Frigate ensure the stability and bioavailability of active pharmaceutical ingredients (APIs) during manufacturing?

Frigate employs advanced formulation techniques, including particle size reduction, and uses stabilizers and excipients to optimize API solubility and bioavailability. Rigorous testing and validation at every production stage ensure the stability of APIs under various storage conditions. 

What steps does Frigate take to meet complex regulatory requirements for pharmaceutical contract manufacturing?

Frigate strictly adheres to international guidelines such as GMP, ICH, and FDA standards. All processes, from raw material sourcing to final packaging, undergo comprehensive validation, ensuring regulatory compliance and quality assurance throughout production. 

How does Frigate handle scale-up challenges from small batches to large-scale commercial production?

Frigate utilizes process optimization and equipment flexibility to ensure smooth scale-up. By conducting trial runs and in-depth process validation, Frigate minimizes batch variability and ensures consistent product quality across different production volumes. 

How does Frigate ensure effective contamination control during the pharmaceutical manufacturing process?

Frigate implements stringent contamination control protocols, including cleanroom environments, air filtration systems, and sterilization procedures. Regular audits and monitoring are conducted to meet the highest standards of cleanliness and prevent cross-contamination. 

What technologies does Frigate use to ensure precision in drug formulation and manufacturing?

Frigate uses advanced technologies like high-shear mixing, encapsulation, and automated filling systems to ensure precision in drug formulation. Real-time monitoring and data analytics ensure process control and minimize human error, improving overall manufacturing efficiency. 

We'd love to Manufacture for you!

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LOCATIONS

Global Sales Office

818, Preakness lane, Coppell, Texas, USA – 75019

Registered Office

23, 6th West Street, Balaji Nagar, Kattur,  Pappakuruchi, Tiruchirappalli-620019, Tamil Nadu, India.

Operations Office

9/1, Poonthottam Nagar, Ramanandha Nagar, Saravanampatti, Coimbatore-641035, Tamil Nadu, India. ㅤ

GENERAL ENQUIRIES

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