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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 4 News #PharmaBuzz

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Interview #SpeakPharma
Vlog #PharmaReel
Data Compilation #PharmaFlow
4 News #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

11 All APIs, 11 USDMF

11 All APIs
11 USDMF

INSPECTIONS & REGISTRATIONS

7 FDA, 1 GDUFA

inspections
7 FDA
1 GDUFA

Only Regulatory Products (API/FDF), Drugs in Developments and News are Updated on this Virtual Booth

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About

WHY CHOOSE CODY LABORATORIES? Two fundamental reasons: No other company can match the quality of our bulk pharmaceuticals, and our expertise with "Scheduled Items" is unmatched. The evidence: Our client list of major drug manufacturers that utilize our substances to produce the safest and purest drugs in the world. On top of that, we offer our clients not only price savings, but an unparalleled willingness to work with and for them. When these factors are carefully considered, Cody Laboratories is your only choice for bulk pharmaceuticals. BUSINESS DESCRIPTION HISTORY OF CODY LABS Cody Laboratories, Inc. (Cody Labs), a wholly owned subsidiary of Lannett Company, Inc., produces active pharmaceutical ingredients ( API's) and finished dosage forms of pain relief medication. Cody Labs was started in 2000 by Ric Asherman, and was located at 331 33rd Street. The company in its infancy produced phentermine hydrochloride. The original facility employed 10 to 15 people. The operations were moved into a new 73,000 square foot facility in 2006. The business was sold to Lannett Company in 2007. Lannett Company, Inc. manufactures and distributes high quality affordable generic medications that are the therapeutic equivalent of the brand-name pharmaceuticals. The company, based in Philadelphia, owns approximately 150,000 square feet of manufacturing space. The current Cody Labs facility is 73,000 square feet located on 15 acres. Upon Lannett's acquisition, the employment increased the total headcount to 40 employees by 2008. Continued growth through 2009 saw employment of administrative, professional and operations staff to the current level of 80 by the end of 2010. In 2008, Cody Labs became one of only seven companies in the United States to be granted an import license for raw opiate material. This allows Cody Labs to manufacture active pharmaceutical ingredients directly from plant extracts and, therefore, be more cost competitive with its competition. This import license also allows Cody labs to provide the API's which Lannett requires to produce finished dosage forms. Lannett has a portfolio consisting of numerous products across a wide range of therapeutic areas. The ability to select viable products for development, efficiently develop such products, including obtaining any applicable regulatory approvals, vertically integrate ourselves into certain specialty markets and achieve economies in production are all critical for our success in the generic pharmaceutical industry. Having the manufacturing expertise, low overhead expenses and efficient product development, manufacturing and marketing capabilities will help us remain competitive in the general pharmaceutical market. Lannett dedicates strategic capital toward developing new products to continually introduce new generic products into the marketplace. The company has cultivated a strong and dependable customer relationship by maintaining adequate inventory levels and demonstrating a responsive order filling system. A majority of our orders are filled and shipped either on the day of, or the day following, the date that we receive the order. The generic drug industry continues to grow with the aging population and the continuing rate of proprietary drug products coming off patent. In addition, the controlled substance drugs are protected from foreign competition as long as a source is available in the United States. Cody Laboratories is organized into several key departments, each one with a critical role in the production of our pharmaceutical products. The departments are: MANUFACTURING Responsible for physical production of finished pharmaceutical products and active pharmaceutical ingredients (API's). PROJECT MANAGEMENT Responsible for the overall project plan and execution of new product development. Coordinates all departments in the development, scale-up, validation, and production of new API's and modifications to existing products and systems. PROCESS DEVELOPMENT Responsible for overseeing the processes required to produce a new product. VALIDATION Responsible for the installation, operation, and performance qualifications of new equipment and processes as dictated by the FDA to ensure reproducible production. Validation is involved from the kilo-lab scale through manufacturing. QUALITY CONTROL DEPARTMENT Responsible for the implementation of quality control procedures in the manufacturing process, and the development of test methods to meet these parameters. Also responsible for overseeing product stability. The Quality Control Laboratory within the department, ensures that every product produced meets the highest standart of purity, as well as testing raw materials and intermediates. QUALITY ASSURANCE DEPARTMENT Ensures that the products manufactured consistently meet or exceed government regulations and customer requirements. DEA Ensures that raw material procurement, development of new products and manufacturing are done in compliance with DEA Regulations. Because of the sensitive nature of the raw materials and the products produced, the company is under the watchful eye of a number of federal and state agencies. Cody Laboratories, Inc. is registered with the DEA for Schedules I - V of the federal controlled substance regulation. In order to initiate and maintain operations, Cody Laboratories, Inc. is inspected by the Drug Enforcement Agency, the Food and Drug Administration, the Wyoming Department of Environmental Quality and the Wyoming State Board of Pharmacy. Cody Laboratories is fully committed to compliance with all agencies.

German Wound CongressGerman Wound Congress

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07 April-09 May, 2025

Bremen, Germany
ICMD ChinaICMD China

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Not Confirmed

08 April-11 May, 2025

Shanghai, China
ICRI Spring ConventionICRI Spring Convention

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Not Confirmed

13-16 April, 2025

Boston, MA

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601 Yellowstone Ave - Cody, WY 82414

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INTERVIEW #SpeakPharma

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“Our unmatched efficiency and track record of faster DMF filings give our customers a critical competitive advantage”

This week, SpeakPharma interviews Pete Werth III, the new president of ChemWerth, a company that has been at the forefront of the generic pharmaceutical industry for over four decades. He shares his vision for ChemWerth, which includes his commitment to strengthening global manufacturing relationships, and enhancing supply chain resilience. Additionally, he highlights the key aspects of a successful drug master file (DMF). HIGHLIGHTS// Pete Werth III, the new president of ChemWerth/ vision for ChemWerth/ commitment to strengthening global manufacturing relationships/ key aspects of a successful drug master file Your father, Peter J. Werth, is recognized as one of the founders of the generic pharmaceutical industry, having built ChemWerth from the ground up over four decades ago. How do you view his legacy? As you take the helm, what key lessons or principles from his leadership do you intend to carry forward? My father, Peter J. Werth, is a true pioneer in the generic pharmaceutical industry. Over his 42‐year tenure, he not only built ChemWerth from a humble garage startup into a global leader in generic API development but also established standards that many in our industry now take for granted. Under his leadership, we filed our very first DMF in 1987 and have since achieved more than 500 DMF filings. With an average review cycle of just 0.79, we have been far outperforming the industry average of 2.5 cycles. His focus on quality, regulatory excellence, and a relentless commitment to customers’ success set the foundation for our reputation as a trusted supplier of over 500 APIs sourced from more than 30 cGMP-certified facilities worldwide. Equally inspiring is his dedication to nurture long-term, mutually beneficial relationships with manufacturing partners across the US, Europe, India, and China, as well as his passion for giving back to the community through philanthropic initiatives. As I take the helm, I intend to build on his guiding principles — sustaining our high standards of quality and compliance while pursuing innovation in regulatory strategy, diversifying our supply chain, and embracing new technologies and approaches to remain competitive in an evolving market. I will also strive to continue his legacy of mentorship, ensuring that our company culture remains rooted in integrity and diligence, with an unyielding focus on making safe, affordable medicines available worldwide. HIGHLIGHTS// trusted supplier of over 500 APIs/ 30 cGMP-certified facilities worldwide/ embracing new technologies and approaches to remain competitive What are your top priorities as the new president of ChemWerth? How do you plan to strengthen and expand relationships with manufacturers worldwide? My immediate priorities as the new president are twofold: to enhance the value we deliver to our customers and, to deepen our relationships with our manufacturing partners worldwide. We will further diversify our supply chain and broaden our product portfolio. Our expansion plans include upgrading equipment, and hiring additional highly skilled scientists, engineers, and GMP auditors. We will also leverage our proprietary product selection and regulatory submission processes. These processes help us get the regulatory filing right the first time, and allows us to be approved 44 percent faster than the industry average. This helps our customers gain a competitive edge in the market. In essence, by strengthening operational excellence and expanding our global network, we intend to continue the company’s long-standing commitment to customer success and process innovation. We plan to reinforce our long-standing relationships with our manufacturers — especially those in strategic markets like China and India — by helping our partners meet the highest standards of regulatory compliance and current good manufacturing practice (cGMP) quality. This balanced approach of strengthening existing partnerships while pioneering new ones is key to maintaining and growing our competitive edge. HIGHLIGHTS// diversify our supply chain and broaden our product portfolio/ commitment to customer success and process innovation/ filings approved 44 percent faster than the industry average When ChemWerth last spoke to PharmaCompass, there was a mention of investing millions of dollars in expanding manufacturing partnerships in China and India. Can you elaborate on the success of these partnerships, and how have they contributed to ChemWerth’s overall growth? Our strategic, multimillion-dollar investments in manufacturing partnerships are a cornerstone of our growth strategy. Over the past few years, these joint ventures have proven their worth by diversifying our supply base and mitigating the risk of global supply chain disruptions — a lesson that became all too clear during the Covid-19 pandemic. These investments are already paying dividends. They help us support manufacturers producing steroids, hormones, veterinary products, and large-volume APIs, while also accelerating the development of small-molecule inhibitors and new generic APIs. We have ensured that our partners are equipped with the latest equipment and trained personnel to meet cGMP standards. By partnering with facilities in these markets, we now have access to state-of-the-art production capabilities that enable us to produce a wider range of APIs at competitive costs. The success of these partnerships is evident in our ability to consistently file DMFs rapidly — often on the first cycle — and deliver affordable, high-quality medicines to patients worldwide. This supports our clients’ growth trajectory and has helped us expand into new markets. This strategy has reinforced our global footprint — supporting our presence in 38 countries with over 100 products — and positioned us well to capitalize on a global generic drug market projected to grow at a compounded annual growth rate of 5.4 percent from 2022 to 2030, to reach a size of US$ 671 billion by 2030. HIGHLIGHTS// strategic multimillion-dollar investments/ support manufacturers producing steroid, hormone, veterinary products/ development of small-molecule inhibitors and new generic APIs/ ensured partners are equipped with the latest equipment and trained personnel ChemWerth has an impressive track record, and an over 40-year relationship with the US Food and Drug Administration (FDA). What are the key aspects of a successful DMF? Are there specific challenges manufacturers face in preparing DMFs, and how does ChemWerth help them overcome these hurdles? ChemWerth’s record of filing over 500 DMFs in 38 countries reflects our commitment to excellence in regulatory compliance and quality management. A successful DMF is built on comprehensive documentation that rigorously follows cGMP guidelines, robust analytical validation, and detailed tracking of every step. Every DMF we file meticulously details the entire manufacturing process — from raw material acquisition to final batch production. This comprehensive approach ensures that our submissions meet the rigorous quality, safety, and efficacy standards expected by the FDA. Our team stays continuously updated on the evolving guidelines and protocols, which allows us to file DMFs that align with current FDA practices. We recognize that many manufacturers face challenges such as complex regulatory requirements, lengthy review cycles, and the need for precise coordination between various production stages. ChemWerth helps them overcome these hurdles by offering end-to-end regulatory support, detailed internal audits, and continuous training on cGMP and FDA requirements. Our efficiency is a critical competitive advantage. By receiving approvals 44 percent faster than the industry average, we help our customers get their products to market faster, resulting in larger market share and increased profits. HIGHLIGHTS// over 500 DMFs in 38 countries/ robust analytical validation/ end-to-end regulatory support What is your vision for ChemWerth over the next few years? How do you plan to navigate the challenges and opportunities in the generic pharmaceutical industry? I plan to continue to add value for our customers, and look for innovative ways to compete in today’s generic pharmaceutical landscape. At ChemWerth, our vision for the future is rooted in both our proud legacy and our relentless drive for innovation. We will further diversify our supply chain and expand our product portfolio. We have begun leveraging our expertise to supply APIs for biosimilars and new drug applications (NDAs), while maintaining our reputation for rapid regulatory approvals. With unwavering determination, we uphold our “First to Quality. Fast to Market.” approach — delivering high-quality APIs to customers worldwide while leveraging our expertise to give them a competitive edge in their markets. HIGHLIGHTS// supply APIs for biosimilars and NDAs/ give customers a competitive edge in their markets

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VLOG #PharmaReel

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DATA COMPILATION #PharmaFlow

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CDMO Activity Tracker: Axplora enhances ADC capacities, Quotient beefs up HPAPI capabilities; Evonik, EUROAPI forge deals

The contract development and manufacturing organization (CDMO) sector witnessed significant activity in the first quarter (Q1) of 2025, characterized by strategic investments, facility expansions, and collaborative partnerships.The quarter saw some significant deals. WuXi Biologics agreed to sell its vaccine manufacturing facility in Dundalk, Ireland, to Merck for € 500 million (US$ 521 million). Quadria Capital announced the acquisition of a 10 percent stake in Aragen for US$ 100 million. This investment will help Aragen accelerate its research and development efforts.Some CDMOs, like India-based Syngene International and Belgium-based Ardena expanded their presence in the US market. Syngene completed the acquisition of its first US biologics facility that it had purchased from Emergent Manufacturing Operations Baltimore for US$ 36.5 million. And, leading nanomedicine developer Ardena purchased a drug manufacturing unit in New Jersey from Catalent. View CDMO Activity Tracker for Q1 2025 (Free Excel Available) Axplora expands its ADC capacities; Quotient Sciences wraps up HPAPI unit upgradeThe antibody-drug conjugate (ADC) market saw considerable investments by CDMOs. Axplora expanded its commercial payload production capabilities at its Le Mans site in France, reinforcing its position as a leading player in ADC manufacturing. This expansion is part of the France 2030 program and builds on Axplora’s track record of supplying 40 percent of the world’s marketed ADCs and 50 percent of ADCs approved by the US Food and Drug Administration (FDA).Samsung Biologics said it will support a series of LigaChem Biosciences’ ADC programs at its new dedicated ADC facility. Similarly, Cerbios-Pharma announced significant enhancements to its ADC production capabilities. Cerbios also announced the expansion of its high potency active pharmaceutical ingredients (HPAPIs) production capabilities. On March 31, Cerbios-Pharma got acquired by Healthcare Advanced Synthesis, a leading developer of APIs, HPAPIs and anticancer compounds. Both these global players are based in Switzerland. Overall, HPAPIs saw significant investments. Quotient Sciences made headlines with the successful completion of a US$ 1.4 million project designed to improve high potency handling capabilities at its Philadelphia (US) facility. The initiative focused on upgrading infrastructure and implementing advanced safety protocols to manage HPAPIs more effectively.Polfa Tarchomin achieved significant milestones in enhancing its pharmaceutical manufacturing capabilities. The company successfully completed the site acceptance test (SAT) for its vial filling and packaging line at the Center for Development and Production of Highly Potent Drugs, ensuring full functionality and compliance with good manufacturing practice (GMP) standards.Additionally, Polfa Tarchomin is installing a high-tech, high-containment robotic ONCO LINE designed for aseptic production of highly potent pharmaceutical products, including lyophilisates and liquid formulations in vials and pre-filled syringes. Developed in collaboration with leading global suppliers, this line supports multiple packaging formats and comes with advanced systems. With an annual production capacity of up to 6 million units, this line will set a new benchmark in pharmaceutical manufacturing.In a significant development for analytical testing, SK Pharmteco launched an enhanced laboratory specifically designed for HPAPIs. The new facility is in California (US). View CDMO Activity Tracker for Q1 2025 (Free Excel Available) Evonik expands RNA portfolio; Catalent to support Galapagos’ CAR-T therapy trialsThe success of mRNA vaccines and the growing interest in RNA therapeutics is luring CDMOs to rapidly expand their capabilities in this emerging area. Evonik, in collaboration with ST Pharm, announced plans to expand its portfolio of RNA and nucleic acid therapeutic services during Q1. The partnership enables Evonik to provide customized nucleic acids from ST Pharm alongside its portfolio of lipid and lipid nanoparticle (LNP) drug product development services.ReciBioPharm secured a grant from the Bill & Melinda Gates Foundation to advance RNA manufacturing technologies that meet FDA standards with a focus on improving access to RNA therapeutics in low- and middle-income countries.The cell and gene therapy sector also witnessed remarkable activity in Q1 2025. Catalent announced it will support Galapagos’ decentralized CAR T therapy trials for GLPG5101 for relapsed/refractory non-Hodgkin lymphoma indications.Similarly, AGC Biologics announced it will manufacture and supply lentiviral vectors for Adaptimmune’s solid tumor cell therapy initiatives. And, Genenta and AGC Biologics strengthened their cell therapy manufacturing pact through a collaboration agreement. This grants Genenta access to the exclusive GMP suite at the AGC Biologics Cell and Gene Center of Excellence in Milan, dedicated to manufacturing cell therapy products. View CDMO Activity Tracker for Q1 2025 (Free Excel Available) EUROAPI, StrainChem join hands to develop peptides; Fermion expands flow chemistry capabilitiesEven traditional therapeutics like peptides and small molecules saw considerable investments by CDMOs. For instance, EUROAPI and StrainChem announced a collaborative venture to develop liquid phase peptides. The partnership aims to harness advanced synthesis techniques and innovative technologies for more efficient peptide manufacturing. Through this collaboration, EUROAPI and StrainChem will offer their customers a one-stop shop solution for peptides. In one of the most ambitious expansions announced this quarter, CordenPharma unveiled plans to invest over € 1 billion (US$ 1.10 billion) over the next three years in building and expanding small, medium, and large peptide manufacturing facilities across Europe and the US. That includes a new greenfield facility for peptide manufacturing in the Basel region of Switzerland, valued at over € 500 million (US$ 553 million).In obesity treatments, Viking Therapeutics agreed to pay US$ 150 million to CordenPharma for the production of its dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) agonist VK2735.In a show of confidence, Indian CDMO Neuland Labs’ board approved a ₹ 3.42 billion (approximately US$ 42 million) capital expenditure plan. The approved capex is earmarked for enhancing the company’s peptide synthesizer reactor capacity and building additional capacity to meet growing demand.In the small molecule space, Fermion announced a strategic investment to expand its flow chemistry capabilities, aiming to enhance processes and sustainability by integrating continuous flow techniques into manufacturing. This technology offers advantages in scalability, process control, and safety, positioning Fermion at the forefront of pharmaceutical innovation.Recipharm announced a major expansion of its aseptic filling capabilities, encompassing process development, pilot-scale production, and clinical supply operations. Similarly, Curia announced significant expansions to its global network of sterile fill-finish sites, aiming to enhance production capacity, streamline supply chains, and improve overall quality in sterile pharmaceutical manufacturing. View CDMO Activity Tracker for Q1 2025 (Free Excel Available) Our viewDuring Q1 2025, the CDMO sector continued to evolve towards higher-value and more complex services. This only underscores the crucial role CDMOs are playing in supporting growth and innovation in the pharmaceutical industry.With the Trump administration in the US triggering a global tariff war, drugmakers have no option but to reshape their supply chains. And this means more business for CDMOs that manufacture drugs in the US. In the coming quarter, we expect strong dealmaking and increased focus on innovation in the CDMO sector.