We offer unparalleled commercial manufacturing flexibility that’s needed for diverse drug development needs. Specializing in adaptable solutions for accelerated programs like orphan drugs, fast track therapies, and rare disease drugs, we ensure smaller batch sizes, expedited timelines, and adjustable production volumes.

Our team, with over 30 years of leadership experience, operates in FDA and cGMP approved facilities in NY, USA. 

We’re committed to quality and scalability, excelling in technical transfers, product launches, and advanced manufacturing technologies from small to large-scale projects, meeting global market demands.

Commercial Manufacturing

Overview

  • Essential Manufacturing Flexibility: Our commercial manufacturing operations are designed to address the varied demands of drug development, ensuring that each product can move seamlessly from R&D to market.
  • Adaptable Solutions for Rapid Development: We provide adaptable commercial manufacturing solutions that are key for orphan drugs, fast track therapies, breakthrough treatments, accelerated approvals, and priority reviews, facilitating a quicker transition from concept to market.
  • Specialized in Rare Disease Drugs: Our commercial manufacturing expertise includes managing smaller batch sizes, expedited timelines, and rapid production volume adjustments, catering specifically to the needs of rare disease drug development.
  • Comprehensive Manufacturing Expertise: Our commitment to commercial manufacturing excellence offers an extensive range of scalable technologies, ensuring a strong commitment to quality at every stage of production.
  • Global Market Supply: Our commercial manufacturing infrastructure ensures a reliable supply to meet global program requirements, maintaining a steady flow of products to markets worldwide.
  • FDA and cGMP Approved Facilities: Our facilities uphold the highest standards in commercial manufacturing, with FDA and cGMP approvals that guarantee high-quality manufacturing standards.
  • Tailored Manufacturing Solutions: We offer tailored solutions for both clinical and commercial manufacturing needs, ensuring that each client’s unique requirements are met with precision and care.
  • Excellence in Technical Transfers and Product Launches: Our commercial manufacturing services include dedicated suites, special handling, and advanced manufacturing technologies, all of which contribute to excellence in technical transfers and product launches.
  • Versatile Manufacturing Scale: From small to large-scale commercial manufacturing services, we support a versatile manufacturing scale, adapting to project needs with agility and efficiency.
  • Innovative Commercial Manufacturing Technologies: We leverage cutting-edge technologies in commercial manufacturing to stay ahead of industry trends and meet the evolving needs of our clients.
  • Sustainable Manufacturing Practices: Our commercial manufacturing processes are designed with sustainability in mind, reducing environmental impact while maintaining product integrity.
  • Quality Assurance in Manufacturing: Every step of our commercial manufacturing process is monitored for quality assurance, ensuring that every product meets stringent regulatory standards.
  • Client-Centric Manufacturing Approach: Our commercial manufacturing strategy is client-centric, focusing on delivering customized solutions that align with our clients’ business objectives.

Commercial Manufacturing Capabilities

  • Manufacturing Expertise in Oral Dosage Forms: We are pros at oral dosage forms with our senior leadership having a heritage in oral dosage form development and production. Our expertise spans across a variety of oral delivery systems
  • Technical Transfers for Commercialization: We excel in technical transfers that ensure a seamless transition of your product from development to commercial manufacturing, maintaining the highest standards of quality.
  • Scale-Up Capabilities for Product Launches: Our commercial manufacturing scale-up capabilities are matched by our expertise in orchestrating successful product launches.
  • Dedicated Suites for Unique Requirements: Within our commercial manufacturing network, we offer dedicated suites that accommodate unique program requirements, including specific air handling, humidity control, and containment needs.
  • Special Handling Expertise for Controlled Substances: We possess specialized commercial manufacturing handling expertise for controlled substances, ensuring compliance and safety throughout the development and commercial supply stages.
  • Advanced Manufacturing Technologies for Bioavailability: Our commercial manufacturing services include a wide range of technologies designed to enhance bioavailability, increase efficiency, and ensure reliability.
  • Serialization Capabilities for Regulatory Compliance: Our serialization capabilities in commercial manufacturing meet the most stringent regulatory requirements, ensuring traceability and quality control.
  • Comprehensive Facilities and Equipment: We invite you to explore our facilities and equipment lists.

Reliable Supply

  • Integrated Commercial Manufacturing Facilities: Our state-of-the-art commercial manufacturing facilities are strategically located in the U.S. and the Asia Pacific region, providing a robust foundation for global operations.
  • Efficient Clinical Supply Services: Through our clinical supply services, we offer fast, efficient, and reliable commercial manufacturing solutions that cater to a global clientele.
  • Expertise in Global Product Launches: Our commercial manufacturing expertise extends to global product launches, ensuring scalable manufacturing processes that can adapt to market demands.
  • Scalable Commercial Manufacturing: We pride ourselves on scalable commercial manufacturing capabilities that support product differentiation, line extensions, and lifecycle management.
  • Commercial Packaging Excellence: Our commercial packaging services are designed to meet diverse needs, from initial design to final delivery, ensuring your product stands out in the marketplace.
  • Lifecycle Management in Commercial Manufacturing: We provide comprehensive lifecycle management services, ensuring that your product remains competitive and compliant throughout its commercial journey.
  • Innovative Commercial Packaging Solutions: Our innovative commercial packaging solutions are tailored to enhance product appeal and preserve integrity, from production to patient.
  • Commercial Manufacturing for Market Adaptability: We ensure our commercial manufacturing processes are flexible and adaptable, ready to respond to the ever-changing market trends and regulations.
  • Strategic Location Advantage: The strategic location of our 2x commercial manufacturing facilities maximizes logistical efficiency and market reach, providing a competitive edge in the industry.
  • Quality Control in Commercial Manufacturing: Our rigorous quality control measures in commercial manufacturing safeguard product quality, ensuring that every batch meets the highest standards.

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FAQs

Here are some frequently asked questions about Commercial Manufacturing

What are commercial manufacturing services?

Commercial manufacturing services encompass the large-scale production of pharmaceutical products following regulatory approval for market launch. These services include process scale-up, formulation optimization, bulk manufacturing, packaging, labeling, and quality control of finished pharmaceutical products. The goal is to ensure a reliable, efficient, and compliant supply of medications to meet market demands.

How do you ensure GMP compliance in commercial manufacturing?

Ensuring GMP (Good Manufacturing Practice) compliance in commercial manufacturing involves adhering to stringent regulatory standards set by authorities like the FDA and EMA. This includes maintaining controlled manufacturing environments, conducting rigorous quality assurance testing, implementing robust standard operating procedures (SOPs), and thorough documentation of all manufacturing processes and quality control measures. Our facilities undergo regular audits and inspections to verify compliance and ensure the highest quality standards.

Can you scale up from clinical to commercial manufacturing?

Yes, we specialize in scaling up from clinical to commercial manufacturing. This process involves optimizing the manufacturing method for larger-scale production, ensuring the final product remains consistent with the product developed during clinical trials. We address challenges such as raw material sourcing, process efficiency, and quality control to ensure a smooth transition to commercial volumes, maintaining product integrity and compliance.

What types of dosage forms can you manufacture commercially?

We can manufacture a wide range of dosage forms commercially, including tablets, capsules, injectables, liquids, suspensions, creams, ointments, and powders. Our state-of-the-art facilities and experienced team allow us to accommodate various manufacturing processes and packaging requirements, ensuring flexibility and capability to meet our clients' diverse product portfolios.

How do you manage quality control in commercial production?

Quality control in commercial production is managed through comprehensive testing and monitoring at every stage of the manufacturing process. This includes raw material testing, in-process controls, and final product testing against established specifications. We utilize advanced analytical methods and equipment to ensure product quality and compliance. Our quality control procedures are integral to our GMP practices, ensuring that every batch produced meets the highest quality standards.

What packaging and labeling services do you offer?

We offer a full range of packaging and labeling services tailored to the needs of commercial pharmaceutical products. This includes blister packaging, bottle filling, cartoning, and serialization for track and trace compliance. Our labeling services accommodate multi-language requirements and regulatory compliance for global markets, ensuring that products are appropriately labeled and packaged for patient safety and convenience.

How do you ensure supply chain reliability for commercial products?

Ensuring supply chain reliability for commercial products involves strategic planning, inventory management, and robust partnerships with qualified suppliers. We implement rigorous supplier qualification processes and maintain safety stock levels to mitigate risks of raw material shortages. Our logistics and supply chain teams continuously monitor and optimize the supply chain for efficiency, cost-effectiveness, and compliance, ensuring uninterrupted product availability.

Can you support the commercial manufacturing of controlled substances?

Yes, we have the capabilities and licenses to support the commercial manufacturing of controlled substances. Our facilities are equipped with secure storage and handling areas, and we adhere to strict regulatory requirements for the manufacturing, packaging, and distribution of controlled substances, ensuring compliance with all legal and safety standards.

What regulatory compliance support do you offer for commercial manufacturing?

We offer comprehensive regulatory compliance support for commercial manufacturing, including assistance with regulatory filings, audit preparation, and compliance with global regulatory standards. Our regulatory affairs team has extensive experience navigating the complex regulatory landscape, ensuring that our manufacturing processes and products meet all necessary requirements for market approval and continued compliance.

How do you handle post-market manufacturing changes?

Handling post-market manufacturing changes involves a structured approach to evaluate the impact on product quality, efficacy, and safety. We work closely with regulatory authorities to ensure that any changes are thoroughly documented, justified, and approved before implementation. Our team assesses the need for additional validation studies and ensures transparent communication with our clients and regulatory bodies throughout the process to maintain product compliance and market availability.