Contract Pharmaceuticals Ltd.

The FDA issued separate Form 483s to India’s Jubilant Generics and Contract Pharmaceuticals Limited Canada in the wake of inspections carried out in the last five months. India’s Jubilant Generics and Contract Pharmaceuticals Limited Canada were each hit with Form 483s by the FDA following inspections that uncovered questionable manufacturing practices. The Jubilant Generics inspection, which took place at the company’s production facility in Bhagwanpur, India, between Jan. 25 and Feb. 2 earlier this year, cited four observations, according to a letter posted April 5 on the U.S. regulatory agency’s website. Inspectors found the facility failed to investigate and identify the root cause of the presence of out-of-specification drugs in a batch of unspecified drugs that were later distributed in the U.S. after they were found in swab samples taken during a cleaning verification process, the FDA said. Additionally, the site’s quality control unit was cited for not keeping proper records or following written procedures after an inspector “observed the presence of at least three uncontrolled investigation documents in a locked bin that were placed for shredding.” The two other observations found the facility didn’t establish appropriate time limits for the completion of each production phase and failed to put control procedures in place that would validate the manufacturing processes. Separately, the agency issued a Form 483 to Contract Pharmaceuticals Limited in the wake of an inspection between Oct. 30 and Nov. 3, 2023, of its Mississauga facility located near Toronto. The FDA cited one observation. The company failed to “thoroughly review any unexplained discrepancy whether or not (a specific) batch has been already distributed.,” the agency said in a letter posted to its website April 3. A third-party contract lab found brucella melitensis, a highly pathogenic microorganism, during an environmental monitoring of the production area. When notified of its presence, however, the company didn’t initiate an incident report in order to conduct a documented investigation of the finding, the agency said.

DUBLIN--( BUSINESS WIRE )--The "New Drug Approvals and Their Contract Manufacture - 2023 Edition" report has been added to ResearchAndMarkets.com's offering. In 2022, the FDA approved c100+ new drug applications (NDAs) and biologics license applications (BLAs). This figure represents a decrease over the 2017-21 period. Both small molecule and biologic new molecular entity (NME) approvals declined substantially, causing overall NDA approvals to drop, which meant fewer commercial-scale production contracts for the most innovative products comparative to other recent years. In June 2021, the FDA granted accelerated approval of Biogen's Aduhelm for Alzheimer's disease, despite there being little to no evidence of clinical benefit and the majority of an FDA advisory panel voting against the drug's approval. This event caused controversy and added to pre-existing claims that the FDA approval process may not be as rigorous as it was in the past, the long-standing push for speed in the FDA approval process having meant a reduced level of certainty and evidence related to a drug. As a result of these issues, there may have been an increased reluctance to authorize innovative drugs for use. COVID-19 vaccine drives have allowed economies and societies to safely reopen during the pandemic. However, new challenges such as rising inflation will bring uncertainty to the ongoing global recovery. The pharma industry faces increasing cost pressures, shrinking consumer spending power, staff shortages, and geopolitical tensions. Contract Manufacturing Organization's (CMO's) will need to find ways to remain competitive in these difficult conditions while maintaining quality and compliance. High inflation will also impact supply chains and R&D activities, and challenge their feasibility. New Drug Approvals and Their Contract Manufacture - 2023 Edition; is the 13th edition in the series of long-running analysis of the CMO industry, using the FDA's NDA approvals as the primary indicator of performance. New Drug Approvals and their Contract Manufacture (formerly called 'CMO Scorecard') is critical for benchmarking the performance of the contract manufacturing organization (CMO) industry and the relative performance of major CMOs. This year's edition includes a discussion of Emergency Use Approvals for COVID-19 and how inflation has impacted pharma manufacturers. Scope This report gives important, expert insight you won't find in any other source. 11 tables and 34 figures throughout the report illustrate major points and trends. This report is required reading for: CMO executives who must have deep understanding of drug approvals and outsourcing to make strategic planning and investment decisions Sourcing and procurement executives who must understand crucial components of the supply base in order to make decisions about supplier selection and management Private equity investors that need a deeper understanding of the market to identify and value potential investment targets Reasons to Buy Overview of NDA drug and vaccine approvals and the levels of outsourcing associated with NDA sub segments Detailed view of CDMO performance by number of drug and vaccine approvals An assessment of pharmaceutical companies' propensity to outsource manufacture, by their market caps, based on the publisher's Contract Service Providers database Outsourcing propensity for New Molecular Entities (NMEs), different dosage forms, and other drug attributes Analysis of NME special product approvals such as those with Accelerated Approval, Orphan, Breakthrough or Fast Track designations and assessment of outsourcing Key Topics Covered: Executive Summary Players Technology Briefing Innovative drug approvals Dose outsourcing of drug approvals Trends Industry Analysis Introduction FDA NDA approvals overview More biologic NME approvals than small molecule equivalents Cell and gene therapies First-in-class First-time approvals Rejected drugs Predicted approvals for 2023 Sponsor trends US vs. EU approval performance FDA EUAs in 2022 for COVID-19 FDA: outsourced dose manufacture Dosage form outsourcing Special product categories Accelerated approvals Orphan drug designation Fast track designation Breakthrough therapy designation Containment Solubility enhancement Outsourcing by company market cap CMO performance Dosage form Outsourced API approvals ANDA approvals What it means FDA approvals decline with a large decrease of NMEs approved COVID-19 vaccine demand waning but there are still lucrative contracts A few large CMOs gain majority of dose contracts High inflation and other business conditions Record high number of ATMP approvals in 2022 Value Chain Companies Appendix Methodology Bibliography Primary research - key opinion leaders Further reading About the Authors Contact the Publisher Companies Mentioned AbbVie Inc ACS Dobfar SpA Aenova Holding GmbH Afton Scientific Corp AGC Biologics Inc Ajinomoto Bio-Pharma Services Akorn Operating Company LLC Alcami Corp Alfasigma SpA Allergopharma GmbH & Co KG Almac Group Ltd Alpex Pharma SA Altasciences Co Inc Alvogen Inc AOP Health ARx LLC ASM Aerosol-Service AG AstraZeneca Plc Astrea SA AtomVie Global Radiopharma Inc Aurobindo Pharma Ltd AustarPharma LLC Avara Pharmaceutical Services Inc Baccinex SA Basic Pharma Bausch & Lomb Pharmaceuticals Inc Baxter Biopharma Solutions Bayer AG Berkshire Sterile Manufacturing LLC BioRamo LLC BioReliance Corp Boehringer Ingelheim Biopharmaceuticals GmbH Boehringer Ingelheim RCV GmbH & Co KG Bora Pharmaceuticals Co Ltd Bristol Myers Squibb Co BSP Pharmaceuticals SpA Bushu Pharmaceuticals Ltd Cambrex Corp Catalent Inc Cenexi SAS Cerovene Inc Chia Tai Tianqing Pharmaceutical Group Co Ltd Contract Pharmaceuticals Ltd Corden Pharma International GmbH CoreRx Inc Corium Inc Curia Global Inc Delpharm SAS Dexcel PT Israel Ltd DPT Laboratories Ltd Eisai Co Ltd EMD Serono Inc Emergent BioSolutions Inc EuroAPI SAS Eurofins Scientific SE And Many More Companies! For more information about this report visit https://www.researchandmarkets.com/r/a0j1ls Source: GlobalData About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

DUBLIN, June 30, 2022 /PRNewswire/ -- The "Pharmaceutical Contract Development & Manufacturing Market by Service, End User - Global Forecast to 2029" report has been added to ResearchAndMarkets.com's offering. The Pharmaceutical Contract Development and Manufacturing Market is expected to grow at a CAGR of 7.5% from 2022 to 2029 to reach $226.35 billion by 2029. Following extensive secondary and primary research and an in-depth analysis of the market scenario, the report presents key industry drivers, restraints, challenges, and opportunities. The growth of the pharmaceutical contract development and manufacturing market is mainly attributed to complex manufacturing requirements, patent expiration, increasing investments in pharmaceutical R&D, the pharmaceutical industry's inclination towards cutting-edge technologies, and the outbreak of the coronavirus pandemic. Moreover, the growing demand for cell and gene therapies and personalized medicines and the growth of the High-potency Active Pharmaceutical Ingredients (HPAPI) and Antibody-drug Conjugates (ADC) markets offer significant opportunities for the players operating in the pharmaceutical contract development and manufacturing market. Based on service, in 2022, the pharmaceutical manufacturing services segment is estimated to account for the largest share due to the growing need to reduce manufacturing costs, the use of advanced technologies and skills for manufacturing, the requirement for high-quality bulk manufacturing, and the growing demand for generic drugs. However, biologics manufacturing services is slated to be the fastest-growing segment during the analysis period due to the adoption of advanced technologies for biologics production, biopharma and pharma companies' inclination towards outsourcing their activities, increasing applications of monoclonal antibodies (mAbs), and the development of next-generation antibody therapies such as antibody-drug conjugates. The API manufacturing services segment is expected to dominate the pharmaceutical contract manufacturing services market. The need to reduce the production cost of APIs, initiatives undertaken by pharmaceutical companies such as the development of new API manufacturing facilities, investments in API manufacturing services, agreements with other key players for expanding API manufacturing services, and the growing need to reduce the time required for drug development are expected to drive the growth of this segment. Based on end user, the large pharmaceutical companies segment is estimated to command the largest share of the pharmaceutical contract development and manufacturing market in 2022. The rising incidence and prevalence of various diseases across the globe generating significant demand for effective medicines and breakthrough biopharmaceutical products and the growing need for state-of-the-art processes are the key factors driving the growth of the large pharmaceutical companies segment. An in-depth analysis of the geographical scenario in the pharmaceutical contract development and manufacturing market provides detailed qualitative and quantitative insights into the five major geographies (North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa) along with the coverage of major countries in each region. North America is estimated to command the largest share of the pharmaceutical contract development and manufacturing market in 2022, followed by Europe, Asia-Pacific, Latin America, and the Middle East & Africa. The key players operating in the pharmaceutical contract development and manufacturing market are Thermo Fisher Scientific Inc. (U.S.), Catalent Inc. (U.S.), Lonza Group Ltd (Switzerland), Recipharm AB (Sweden), Vetter Pharma-Fertigung GmbH & Co. KG (Germany), Piramal Enterprises Limited (India), Almac Group (U.K.), Cambrex Corporation (U.S.), Samsung Biologics Co., Ltd (South Korea), Siegfried Holding AG (Switzerland), FUJIFILM Diosynth Biotechnologies (Japan), Aenova Group GmbH (Germany), WuXi Biologics (Cayman) Inc. (China), and Aurobindo Pharma Ltd. (India), among others. Key Topics Covered: 1. Introduction 2. Research Methodology 3. Executive Summary 4. Market insights 4.1. Introduction 4.2. Drivers 4.2.1. Complex Manufacturing Requirements of the Pharmaceutical industry and Manufacturers' Growing inclination Toward the Use of Cutting-Edge Technologies 4.2.2. Rising Demand for Generic Medicines and Biologics 4.2.3. Patent Expiration 4.2.4. Increasing Investments in Pharmaceutical R&D 4.2.5. Outbreak of the COVID-19 Pandemic 4.3. Challenges 4.3.1. Shortage of Skilled Professionals 4.3.2. Introduction of Serialization 4.4. Opportunities 4.4.1. Growing Demand for Cell Therapies, Gene Therapies, and Personalized Medicines 4.4.2. Growth in High Potency Active Pharmaceutical Ingredients (HPAPI) and Antibody-drug Conjugates (ADC) Markets 4.5. Industry Trends 4.5.1. Virtual Business Models 4.5.2. Growing Consolidation Among CDMO Market Players 5. Pharmaceutical Contract Development and Manufacturing Services Market, by Type 5.1. Introduction 5.2. Pharmaceutical Manufacturing Services 5.2.1. Active Pharmaceutical ingredient (API) Manufacturing Services 5.2.2. Finished Dosage Forms (FDF) Manufacturing Services 5.2.2.1. Parenteral/Injectable Manufacturing Services 5.2.2.2. Tablet Manufacturing Services 5.2.2.3. Capsule Manufacturing Services 5.2.2.4. Oral Liquid Manufacturing Services 5.2.2.5. Other Formulations 5.3. Drug Development Services 5.4. Biologics Manufacturing Services 5.4.1. Active Pharmaceutical Manufacturing Services (API) Manufacturing Services 5.4.2. Finished Dosage Form Manufacturing (FDF) Services 6. Pharmaceutical Contract Development and Manufacturing Market, by End User 6.1. Introduction 6.2. Large Pharmaceutical Companies 6.3. Small & Mid-Size Pharmaceutical Companies 6.4. Generic Pharmaceutical Companies 7. Pharmaceutical Contract Development and Manufacturing Market, By Geography 7.1. Introduction 7.2. North America 7.2.1. U.S. 7.2.2. Canada 7.3. Europe 7.3.1. Germany 7.3.2. U.K. 7.3.3. France 7.3.4. Italy 7.3.5. Spain 7.3.6. Rest of Europe (RoE) 7.4. Asia-Pacific 7.4.1. China 7.4.2. India 7.4.3. Japan 7.4.4. Rest of Asia-Pacific (ROAPAC) 7.5. Latin America 7.5.1. Brazil 7.5.2. Mexico 7.5.3. Rest of Latin America 7.6. Middle East & Africa 8. Competitive Landscape 8.1. Introduction 8.2. Key Growth Strategies 8.3. Competitive Benchmarking 8.4. Market Share Analysis (2021) - TOP 19 Players 8.4.1. Lonza Group Ltd. (Switzerland) 8.4.2. Catalent INC. (U.S.) 8.4.3. Thermo Fisher Scientific INC. (U.S.) 8.4.4. Samsung Biologics Co., Ltd. (South Korea) 8.4.5. Recipharm AB (Sweden) 9. Company Profiles (Business Overview, CDMO Facilities, Financial Overview, Service Portfolio, Strategic Developments) 9.1. Cambrex Corporation 9.2. Samsung Biologics Co., Ltd. 9.3. Siegfried Holdings AG 9.4. FUJIFILM Diosynth Biotechnologies 9.5. Aenova Group 9.6. Wuxi Biologics, Inc. 9.7. Aurobindo Pharma, Ltd. 9.8. Vetter Pharma international GmbH 9.9. Thermo Fisher Scientific, Inc. 9.10. Catalent, Inc 9.11. Recipharm AB 9.12. Almac Group 9.13. Lonza Group Ltd. 9.14. Piramal Enterprises Limited 9.15. Fabbrica Italiana Sintetici S.p.A. 9.16. Fareva SA 9.17. C.H. Boehringer Sohn Ag & Co. KG. 9.18. Jubilant Pharmova Limited 9.19. Curia Global, Inc. 10. Appendix For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1904 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets