COUNT ON US FROM NON-STERILE TO STERILE FROM GELS AND CREAMS TO OINTMENTS AND AEROSOLS FROM CONCEPT TO COMMERCIALIZATION FROM VIRTUAL TO LARGE PHARMA

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1 COUNT ON US FROM NON-STERILE TO STERILE FROM GELS AND CREAMS TO OINTMENTS AND AEROSOLS FROM CONCEPT TO COMMERCIALIZATION FROM VIRTUAL TO LARGE PHARMA

2 WHO WE ARE DPT is a Contract Development and Manufacturing Organization, or CDMO, with extensive experience in providing fully integrated services from concept to commercial manufacturing. Our mission is to improve health and quality of life by providing the best solutions for your development and manufacturing needs. We accomplish this through innovation, superior service and cuttingedge technologies. THE INDUSTRY SOURCE FOR SEMI-SOLIDS & LIQUIDS 1,000+ employees More than 100 scientists and engineers 5 cgmp facilities Exemplary quality and regulatory history Widely recognized in the industry as one of the leading CDMOs

3 OUR HISTORY DPT s strong heritage dates back to 1938 when it began as Texas Pharmacal Company, widely recognized as the first dermatology company in the United States. After several acquisitions, Texas Pharmacal was renamed Dermatological Products of Texas in A decade later, the company changed its name to DPT Laboratories, Ltd. This marked the beginning of a new era as our focus expanded into providing comprehensive pharmaceutical development and manufacturing services for highly regulated products. Today, we are well-known in the industry for our unique capabilities, reputation for quality and expertise in sterile and non-sterile semi-solid and liquid dosage forms. With operations in both San Antonio, Texas, and Lakewood, New Jersey, we have the resources and capacity to efficiently serve your pharmaceutical development and manufacturing needs. No other company can match our 75-year history of financial strength, stability and technical expertise in semi-solids and liquids. As we continue to grow, our priority remains the same. We will continue to exceed our customers expectations for quality and service.

4 CENTER OF EXCELLENCE FOR RESEARCH & DEVELOPMENT DPT provides end-to-end pharmaceutical development services at our 40,000-square-foot Research & Development center in San Antonio, Texas. We have over 50 of the industry s leading scientists, who combine decades of semi-solid and liquid expertise with leading-edge technologies to provide customized solutions to your unique development needs. Whether your current project is for pre-formulation of a new chemical entity or optimization of an existing drug delivery system, we can help. Let our development services become a valuable extension of your organization s strategy. COMPREHENSIVE DEVELOPMENT SERVICES Pre-formulation and formulation Analytical development and validation Process development and validation Stability studies under ICH and custom conditions Microbiology testing Packaging identification and specification development Clinical trial material manufacturing Regulatory submission support

5 CENTER OF EXCELLENCE FOR SEMI-SOLIDS & LIQUIDS DPT s 450,000-square-foot manufacturing center in San Antonio, Texas, specializes in providing the best manufacturing solutions for semi-solid and liquid dosage forms. From this location, our experienced team of engineers and technicians provides a full spectrum of services from clinical and development projects to full-scale commercial production. Our exemplary regulatory history and strong focus on semi-solids and liquids ensure that we are the best solution for your manufacturing needs. MANUFACTURING SERVICES cgmp batch sizes from 0.3 kg to 25,000 kg Compartmentalized, controlled environment and XP compounding Controlled substances Schedule III V Extensive filling, finishing and secondary packaging capabilities Site and technical transfers Full validation services Robust quality systems Specialized manufacturing capabilities for aerosols

6 CENTER OF EXCELLENCE FOR STERILE & SPECIALTY PRODUCTS Building on our reputation as the industry leader for semi-solids and liquids, DPT s Sterile & Specialty Products center in Lakewood, New Jersey, specializes in the development and aseptic manufacturing of products to meet sterile requirements. The 175,000-square-foot state-of-the-art site has the latest filling equipment and newest aseptic processing suites in the industry to efficiently manufacture your product. We provide unique solutions for clinical trial material manufacturing and a wide range of sterile commercial manufacturing options. Aseptic production of sterile dosage forms includes small-volume parenterals, ophthalmic preparations, preservativefree nasal sprays, sterile ointments and specialty products. ASEPTIC MANUFACTURING SERVICES Pre-clinical, clinical and commercial manufacturing Sterile component preparation or procurement Aseptic filling Terminal sterilization Site and technical transfers State-of-the-art microbiology lab Controlled substances Schedule II V

7 QUALITY BY DESIGN DPT is at the forefront of offering Quality by Design (QbD), a systematic approach to formulation and manufacturing development. QbD is a growing trend, and regulatory agencies expect that products will be developed using QbD. Without QbD, quality must be inspected in to a product at the end of the manufacturing cycle. With QbD, the factors that contribute to an approvable, quality product are understood up front. This enables the manufacturing team to address sources of risk, resulting in higher assurance of product quality and additional opportunities for manufacturing efficiency and flexibility. QbD can reduce costs through the life cycle of the product. POTENTIAL BENEFITS OF USING QbD: Speed: More efficient use of development time Cost control: More efficient use of development funds Submissions: Ability to meet submission guidelines and expectations Approvals: Reduced approval times and fewer queries from the FDA Manufacturing: Fewer lost batches and manufacturing deviations Reliability: Greater reliability Inspections: Fewer inspections of manufacturing sites ROI: Cost savings and increased revenue

8 WHAT MAKES DPT THE BEST CHOICE? Based on our experience and proven expertise in semi-solid and liquid dosage forms, you can depend on DPT to successfully guide your project from development to commercial manufacturing. Our broad range of services eliminates the need for costly site and technical transfers. And, as always, our outstanding commitment to quality ensures that your product meets the highest standards at each stage. PERFORMANCE AND QUALITY YOU CAN COUNT ON Financial strength for over 75 years Exemplary quality and regulatory history Excellent on-time delivery average Unmatched technical expertise Bringing it all together is what sets DPT apart. Contact us today at CALL-DPT to learn more about putting our unmatched expertise, experience and capabilities to work for you.

9 DPT COUNT ON US DPT Laboratories, Ltd. 318 McCullough Ave., San Antonio, TX CALL-DPT ( ) Center of Excellence for Research & Development 3300 Research Plaza San Antonio, TX Center of Excellence for Semi-solids & Liquids 307 E. Josephine Street San Antonio, TX Center of Excellence for Sterile & Specialty Products 1200 Paco Way Lakewood, NJ 08701