Key Areas of Commercial Production Capabilities 

Commercial Drug Product Manufacturing 

• Full-scale production of topical and transdermal drug formulations 

• GMP-compliant, FDA- and EMA-approved manufacturing facilities 

• Robust process validation and quality control for market-ready products 

🔹 [Learn More About Commercial Drug Product Manufacturing →] 

Compounding with Axomatic Machines 

• Precision-based compounding for uniform formulation consistency 

• Automated, high-efficiency emulsification and homogenization 

• Capability to handle various semi-solid and liquid formulations 

🔹 [Learn More About Compounding with Axomatic Machines →] 

Filling, Packaging & Serialization 

• Primary and secondary packaging solutions for global distribution 

• Serialization and tamper-proof packaging for regulatory compliance 

• Flexible filling solutions for various container types (tubes, bottles, pumps, etc.) 

🔹 [Learn More About Filling, Packaging & Serialization →] 

Highly Potent & Hormonal Products Manufacturing 

• Dedicated high-containment manufacturing for potent and hormone-based drugs 

• GMP-certified cleanroom facilities with advanced air handling systems 

• Strict control of occupational exposure limits (OEL) and worker safety measures 

🔹 [Learn More About Highly Potent & Hormonal Products Manufacturing →] 

Quality Control Labs in Manufacturing Facilities 

• In-house quality control (QC) testing for batch release and compliance 

• Analytical and bioanalytical testing for potency, stability, and purity 

• Regulatory-compliant data management and validation protocols 

🔹 [Learn More About Quality Control Labs →] 

Small-Scale Commercial Manufacturing 

• Flexible production capabilities for orphan drugs and niche formulations 

• Custom batch sizes for low-volume, high-value pharmaceuticals 

• Scalable solutions for transitioning from clinical to commercial supply 

🔹 [Learn More About Small-Scale Commercial Manufacturing →] 

Why Choose MedPharm for Commercial Production? 

• Industry-leading expertise in topical and transdermal drug manufacturing 

• Regulatory-compliant production for IND, NDA, and ANDA filings 

• GMP-certified facilities that support full-scale manufacturing 

• Seamless integration with formulation development and scale-up processes 

• Comprehensive analytical and quality control for market-ready products 

Deliver High-Quality Commercial Drug Products with MedPharm’s Expertise 

MedPharm leverages state-of-the-art manufacturing capabilities enforces regulatory-driven quality assurance and offers flexible production solutions to ensure that your topical and transdermal drug products are manufactured to the highest standards for global market success. 

Regulatory Compliance & Market Readiness 

✔ GMP, FDA, EMA, and ICH-compliant manufacturing and quality control 

✔ CMC (Chemistry, Manufacturing, & Controls) documentation for global regulatory submissions 

✔ Post-approval process validation and lifecycle management 

✔ Supply chain management and distribution readiness for global markets 

🔹 [Learn More About Our Regulatory & Compliance Expertise →] 

 Why Choose MedPharm for Commercial-Stage Development? 

✅ Industry-leading expertise in large-scale pharmaceutical manufacturing 

✅ Regulatory-compliant analytical testing and quality assurance 

✅ Seamless transition from clinical to commercial production 

✅ Cutting-edge process technologies for cost-effective manufacturing 

✅ Customizable specialty solutions for complex and niche drug products 

Commercial Manufacturing Capabilities

Built for Commercial Success 

At MedPharm, we don’t just scale our operations; we scale them smartly. Our manufacturing facilities are specifically designed to support the commercial production of semisolid and liquid dosage forms, with a strong emphasis on quality and efficiency. 

Our Commercial Manufacturing Capabilities Include: 

• Topical and Transdermal Dosage Forms: We produce creams, gels, ointments, lotions, foams, and solutions. 

• GMP-Compliant Facilities: Our facilities are designed and maintained in accordance with U.S. FDA, EMA, MHRA, and global regulatory standards. 

• Scalable Batch Sizes: We offer flexible infrastructure to accommodate market demand and future growth. 

• Advanced Process Controls: Our operations include real-time monitoring and in-process testing to ensure batch consistency. 

• Analytical Testing and Release: We have fully integrated quality control laboratories for batch release, stability testing, and ongoing quality assurance. 

• Packaging and Labeling: We provide commercial packaging support for a variety of container types and configurations. 

Integrated for Success 

We combine the expertise of formulation scientists, manufacturing engineers, regulatory experts, and quality professionals to ensure your commercial program is aligned, agile, and fully supported. Our cross-functional approach delivers: 

• Seamless technology transfer from clinical to commercial scale. 

• Chemistry, Manufacturing, and Controls (CMC) support for NDA, ANDA, and MAA submissions. 

• Rapid responses to post-approval changes and lifecycle management needs. 

• Global supply readiness with comprehensive quality assurance oversight. 

Why Choose MedPharm for Commercial Manufacturing? 

• Focused Expertise: We are 100% dedicated to topical and transdermal drug products. 

• Global Compliance: We have a proven track record of meeting FDA, EMA, and MHRA standards. 

• Collaborative Mindset: We treat your product as if it were our own. 

• Audit-Ready at All Times: We maintain unwavering quality, thorough documentation, and are always prepared for inspections. 

• Built for Longevity: We foster long-term partnerships designed to grow with your commercial success. 

A Partner That Grows With You 

Launching a product is just the beginning. At MedPharm, we don’t just manufacture; we evolve alongside you. From market entry to global expansion, our team is prepared to scale your success. 

Let’s manufacture with purpose and deliver with confidence. 

Filling, Packaging & Serialization

Ensuring Market-Ready, Compliant Drug Products

MedPharm offers comprehensive solutions for filling, packaging, and serialization that comply with global regulatory standards, ensuring the integrity, efficiency, and traceability of your products. Our GMP-certified manufacturing facilities guarantee that topical and transdermal drug products are filled accurately, packaged securely, and fully serialized for commercial distribution. 

With both automated and semi-automated filling lines, as well as secondary packaging solutions, MedPharm provides end-to-end track-and-trace compliance. This ensures that your drug products reach the market safely and efficiently. 

Comprehensive Filling, Packaging & Serialization Services 

Automated & Semi-Automated Filling 

✔ Precision filling for creams, gels, ointments, and lotions 

✔ Tube, jar, pump, and unit-dose filling solutions 

✔ Customizable batch sizes for clinical and commercial supply 

✔ Aseptic and controlled-environment filling options 

🔹 [Learn More About Our GMP Filling Capabilities →] 

Advanced Packaging Solutions 

✔ Primary and secondary packaging tailored to product requirements 

✔ Cartoning, labeling, and tamper-evident sealing 

✔ Regulatory-compliant packaging for global distribution 

✔ Customization for small-batch and niche-market products 

🔹 [Learn More About Our Commercial Packaging Solutions →] 

Serialization & Track-and-Trace Compliance 

✔ Full serialization and aggregation for global regulatory compliance 

✔ Meets DSCSA, EU FMD, and international serialization requirements 

✔ Track-and-trace technology ensuring product security and authenticity 

✔ Integration with global distribution networks for supply chain visibility 

🔹 [Learn More About Our Serialization Capabilities →] 

Seamless Integration with Manufacturing & Quality Control 

✔ End-to-end manufacturing, filling, and packaging for commercial success 

✔ GMP-compliant processes with stringent quality oversight 

✔ On-site quality control labs ensuring compliance at every stage 

🔹 [Learn More About Our GMP Manufacturing Facilities →] 

Why Choose MedPharm for Filling, Packaging & Serialization? 

✅ State-of-the-Art Filling & Packaging Lines – Supporting high-volume and small-batch production 

✅ GMP-Compliant & Regulatory-Ready Solutions – Meeting FDA, EMA, and global serialization standards 

✅ Customizable Packaging Options – Flexible for clinical and commercial product needs 

✅ End-to-End Product Security – Ensuring traceability, authentication, and compliance 

✅ Seamless Tech Transfer & Commercial Scale-Up – Supporting market launch and global distribution 

Deliver a Market-Ready Product with MedPharm’s Filling, Packaging & Serialization Expertise 

MedPharm guarantees precise filling, secure packaging, and complete serialization compliance, facilitating safe and efficient product launches in global markets. 

Highly Potent & Hormone Products Manufacturing

Safe. Scalable. Specialized.  

At MedPharm, we recognize that manufacturing highly potent and hormone-based drug products requires more than standard capabilities. It demands an elevated level of control, precision, and compliance. With purpose-built containment solutions, a skilled workforce, and extensive formulation knowledge, we offer end-to-end development and GMP manufacturing of these sensitive products with safety and confidence. 

From early-phase clinical supply to full-scale commercial production, our team supports programs involving active pharmaceutical ingredients (APIs) with low occupational exposure limits (OELs), including corticosteroids, estrogens, and other hormone therapies. 

Dedicated to Safe and Compliant Manufacturing 

MedPharm’s approach to manufacturing highly potent and hormone products combines engineering controls, operational excellence, and a robust safety culture. Our facilities are designed to mitigate risk at every stage, protecting your product, your team, and your patients. 

Key Capabilities Include:  

• Specialized Manufacturing Suites 

• Segregated, negative-pressure environments equipped with HEPA filtration and cleaning validation procedures to prevent cross-contamination. 

• Handling of HPAPIs and Hormones 

Safe and contained handling of low OEL compounds, including corticosteroids, estrogens, progesterones, and androgens. 

• GMP Production for Topical Dosage Forms 

Production of creams, ointments, gels, foams, and solutions containing potent and hormone-based APIs. 

• Trained and Qualified Personnel 

Specialized teams undergo continuous training in safe handling, containment, and PPE protocols. 

• Validated Cleaning and Decontamination Procedures 

Rigorous verification processes to ensure product and operator safety between batches and projects. 

• On-site Analytical and Microbiology Testing 

Integrated QC labs to support release, stability, and method validation for potent products. 

Integrated Support from Development to Commercialization 

We function as an extension of your team, providing scientific, regulatory, and manufacturing expertise to ensure your product’s success from start to finish. Whether you are formulating a topical corticosteroid or scaling a hormone therapy for global markets, MedPharm ensures that your program is:  

• Scientifically sound  

• Manufacturing-ready  

• Regulatory-compliant  

• Safely executed at every stage 

Why Choose MedPharm?  

• Specialized Containment Expertise 

Proven capabilities in the safe development and manufacturing of highly potent and hormone-containing products. 

• Topical & Transdermal Focus 

Deep understanding of formulation behavior, skin absorption, and performance for semi-solid and liquid dosage forms. 

• Global Regulatory Experience 

Manufacturing practices aligned with FDA, EMA, MHRA, and other global regulatory authorities. 

• Flexible Capacity & Long-Term Partnership 

Ability to accommodate clinical to commercial-scale batch sizes, with infrastructure designed to grow alongside your product. 

Potent Products, Powerful Partnership 

Manufacturing highly potent and hormone-based therapies requires a partner you can trust. MedPharm provides the facilities, expertise, and culture of care that make safe, compliant manufacturing possible every time.  

Let’s manufacture safely. Let’s manufacture smart. Let’s manufacture with MedPharm.