The global pharmaceutical contract development and manufacturing organization (CDMO) industry is rapidly expanding, having grown from a value of $94.17 billion recorded in 2022 to an expected $172.02 billion by 2032. This sector plays a pivotal role in the pharmaceutical manufacturing industry, providing end-to-end services in drug development, validation, and manufacturing. The CDMO sector is also where pharmaceutical companies outsource analytical activities, particularly method development and validation as well as stability studies. Within India, this sector has experienced tremendous growth, significantly driven by the growing generic medicines market. Challenges regarding time constraints for filing submissions, simultaneously juggling multiple projects and products, and a lack of expertise continue to persist, demanding reliable outsourcing partners to take the burden off the companies.
Established in 1995, Recipharm, a Sweden-based global CDMO, emerges as the ideal partner, possessing diverse region-specific industry knowledge and expertise, guiding clients through industry complexities with ease.
Comprehensive Services
Recipharm understands the full drug development process, from the challenges of drug substance and formulation development to device selection and customization to commercial manufacture. This allows them to provide added value by supporting customers across every stage of the project. Recipharm’s offerings are classified under four major categories: Recibiopharm, aseptic fill-finish, solids, and others. Recibiopharm focuses on biologics development and RNA therapies. Aseptic fill & finish is dedicated to sterile filling and lyophilization of both small and large molecules including ophtalmics and vaccines.
Recipharm can manage the complexity, delivering the optimal drug product for the project’s needs ranging from pre-formulation and clinical development through to scale-up and commercial manufacturing. Services include technology transfer, product development, manufacturing of solids, semi-solids, liquids, pharmaceutical packaging, special technologies, modified release, controlled substances, continuous manufacturing, fixed-dose combination, commercial manufacturing, stability studies, and regulatory excellence.
Recipharm Analytical Solutions offers multiple services under one roof and has emerged as a distinguished center of excellence within the broader network of Recipharm units. The facility boasts state-of-the-art laboratories equipped with modern analytical instruments meticulously designed to meet customer needs. As leaders in the field of method development and validations, Recipharm continuously invests in innovative techniques and nurtures a talented workforce to maintain a prominent position in the industry.
With a client-centric approach at heart, & a strategic outlook that helps it stay abreast of industry evolutions and dynamic market demands, Recipharm is on track to becoming the global leading authority in the CDMO sectorDr. Ramesh Jagadeesan, Vice President
Analytical methods are critical tools for ensuring the quality and safety of pharmaceutical products throughout the drug development process. At Recipharm, all methods are developed using a quality-by-design approach (QbD) by understanding the critical quality attributes (CQA) of the products or substances. Appropriate methods are selected based on the specific attribute being measured, for example, HPLC, UPLC, and UHPLC with a range of detectors like UV, PDA, ELSD, RI, Fluorescence, and CAD. Recipharm has experience in method development for products like high-potent drugs, low-label claim formulations, fixed-dose combinations, lozenges, pellets, mini-tablets, over-the-counter (OTC) products, and cosmetics.
Analytical method validation is used to demonstrate that the analytical procedure is fit for its intended purpose. Recipharm conducts all validations as per current guidelines from ICH, FDA, EU, and ANVISA. Recipharm is also involved in method transfer activities such as direct transfer, indirect transfer, and collaborative validations. Recipharm’s analytical expertise and experience are utilized to successfully transfer methods to any lab across the globe.
Stability Testing & Reverse Engineering
Stability is a critical quality attribute (CQA) for pharmaceuticals. Stability study can also provide justification for extending or extrapolating use/review periods. The range of stability chambers available at Recipharm is notable for its high capacity, enabling efficient handling and storage of significant sample volumes for both storage and analysis. Stability analysis encompasses real-time or room temperature, accelerated, intermediate, freeze/thaw, bulk hold, static thermal, photostability, shipping, the period after opening, and in-use stability studies.
Reverse engineering or deformulation analyzes competitor drugs to match their qualitative and quantitative makeup, crucial for proving a generic’s bioequivalence to the reference listed drug (RLD). This ensures safety, efficacy, and consistency. Recipharm offers excipient composition analysis within a ±5 percent accuracy to aid clients in aligning their products with reference-listed drugs (RLDs).
Mutagenic impurities, such as nitrosamines, elemental impurities, and extractables and leachables (E&L), are significant considerations in the safety assessment of small-molecule drugs. Recipharm has also extended its service to testing nitrosamines, extractables and leachables, and elemental impurities, thereby ensuring product quality and regulatory adherence.
Recipharm is dedicated to adding value by supporting clients across every stage of product development to commercial manufacturing. “Recipharm’s steadfast commitment to continuous improvement has given customers the confidence to entrust us with their products. By investing time into developing a comprehensive understanding of their strategic goals, Recipharm can deliver tailored solutions that have a lasting impact. Recipharm has the experience to help clients create effective formulations for combination drug products, ensuring that their innovation achieves its full potential", shares Dr. Ramesh Jagadeesan.
Industry Expertise
In addition to the design and development expertise that it boasts, the company also stands out for its capabilities in supporting time-sensitive projects, enabling it to accelerate project progress by leveraging advanced lab instruments and combining various tools for swift results for complex projects. The firm’s capabilities for handling complex projects set it apart from other industry players.
Future Roadmap
Recipharm is adopting flexible manufacturing models to remain agile, innovative, and responsive to evolving market needs. By leveraging cutting-edge technologies, process automation, continuous manufacturing, and real-time monitoring, Recipharm can adapt production processes efficiently. Recipharm possesses a dedicated team of scientists who work tirelessly to drive its R&D initiatives across verticals.
With a client-centric approach at heart, and a strategic outlook that helps it stay abreast of industry evolutions and dynamic market demands, Recipharm is on track to becoming the global leading authority in the CDMO sector.
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