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.
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- Instant Quotation
- On-Time Delivery
- Affordable Cost
Our Pharmaceutical Contract Manufacturing Process
The process begins with detailed discussions to define product requirements, including formulation, dosage forms, and regulatory standards.
Experts develop the optimal formulation by selecting suitable ingredients, ensuring stability, bioavailability, and compliance with pharmacological standards.
A scalable manufacturing process is designed with considerations for equipment, batch size, and process optimization to ensure efficiency in large-scale production.
All processes and products undergo rigorous testing to meet regulatory guidelines (FDA, EMA, etc.), ensuring they are safe and market-ready.
The production phase involves strict quality control, where each batch is tested for consistency, potency, and purity according to predetermined specifications.
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
The process begins with detailed discussions to define product requirements, including formulation, dosage forms, and regulatory standards.
Experts develop the optimal formulation by selecting suitable ingredients, ensuring stability, bioavailability, and compliance with pharmacological standards.
A scalable manufacturing process is designed with considerations for equipment, batch size, and process optimization to ensure efficiency in large-scale production.
All processes and products undergo rigorous testing to meet regulatory guidelines (FDA, EMA, etc.), ensuring they are safe and market-ready.
The production phase involves strict quality control, where each batch is tested for consistency, potency, and purity according to predetermined specifications.
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 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.
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 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 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, 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.
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.
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, 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.
- Solid Progress
What You Gain with Us
We make your profitability and operations easier with practical approach.
↓ 7-8%
OPS COST
↓ 2-3%
COGM
3X
Aggregation
↑ 25%
Machinery Utilisation
↓ 50%
Expedition
↑ 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.
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What Our Customers Say about Frigate
21%
Faster Manufacturing
Having Doubts? Our FAQ
Check all our Frequently Asked Question
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.
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.
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.
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.
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.
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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
