Cody Laboratories, Inc. DMF, CEP, Written Confirmations, FDF, Prices, Patents, Patents & Exclusivities, Dossier, Manufacturer, Licensing, Distributer, Suppliers, News, GMP

Virtual Booth

Contact Supplier

Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

VISIT THE VIRTUAL BOOTH
Review portfolio & marketing content
CONTACT DETAILS
Google Map, LinkedIn, Emails...

DIGITAL CONTENT

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

media
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

Update your Virtual Booth on PharmaCompass, ask us

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.

CPhI North America CPhI North America

Not Confirmed

Not Confirmed

20-22 May, 2025

Pennsylvania Conv Center, Philadelphia
World Vaccine Conferen...World Vaccine Conference

Not Confirmed

Not Confirmed

22-24 April, 2025

Washington DC
CophexCophex

Not Confirmed

Not Confirmed

22-25 April, 2025

Kintex

List your booth number for exhibitions, ask us

CONTACT DETAILS

Click the arrow to open the dropdown

Country

U.S.A

Address

601 Yellowstone Ave - Cody, WY 82414

Telephone

(307)587-7099

enquiries@pharmacompass.com

Website

https://www.codylabs.com/

YouTube

Digital content

Create Content with PharmaCompass, ask us

INTERVIEW #SpeakPharma

[Sponsored by another company]

“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

Impressions: 923

VLOG #PharmaReel

[Sponsored by another company]

Leading Global Biotechnology and Biomaterial Company

DATA COMPILATION #PharmaFlow

[Sponsored by another company]

How Trump’s tariffs on imported drugs can hurt supply chains, consumers and industry

Ever since Donald Trump has moved into the White House for a second term, there has been turmoil across the world. One of the issues that has been of concern is ‘tariffs’. Trump is keen to reduce United States’ trade deficit through import tariffs.Since the mid-1990s, the US has been importing drugs from across the world largely tariff-free, and its drug imports have risen consistently. In 2024, the US imported US$ 213 billion worth of medicines, which was more than two and a half times the total of its drug imports ten years back.Until recently, it seemed like the administration would spare the pharmaceutical sector. But at a fundraiser dinner held for the Republican Party last week, Trump said: “We're going to be announcing very shortly a major tariff on pharmaceuticals”. The pharma tariffs, he said, would be “at a level that you haven’t really seen before”.The US is the largest consumer of pharmaceuticals globally, accounting for 45 percent of global sales. Given the nature of the global pharma industry, ‘major tariffs’ would have far-reaching impact. PharmaCompass studies the likely impact of tariffs on drug imports into the US, and whether they would serve the purpose they intend to.Cost of import tariffs, setting up domestic capacities will be borne by US consumersThe Trump administration has two key objectives behind implementing drug import tariffs. One, it wants to secure US drug supply chains by onshoring drug production. Two, it wants to create more manufacturing jobs in the US. Will tariffs be successful in achieving these objectives?Importers generally pay the tax and pass it on to the consumer. Bernstein analyst Courtney Breen estimates that in the worst-case scenario, tariffs could result in an extra US$ 53 billion in costs paid for pharmaceutical imports. According to economist Ernie Tedeschi, “costs for prescription drugs would rise by an average of around US$ 600 per year per household” in the US. Not all of that would be ‘out-of-pocket’, and families may “end up paying higher insurance premiums [and] higher co-pays”.Many drugmakers may want to avoid that cost, and shift manufacturing to the US. Though American drugmakers Eli Lilly and Johnson & Johnson have announced mega investments in the US, it’s difficult to say if other drugmakers will find it viable to set up capacities. Having said that, just this week Novartis announced a US$ 23 billion investment in the US.Overall, resources are expensive in the US. Due to heavy reliance on imports, the country does not have industrial plants needed for large-scale production. Factors like labor regulations, high cost of living, mandatory benefits etc, have made the workforce quite expensive. It’s puzzling how any drugmaker will overcome these challenges and create manufacturing jobs. Even if they do, the high costs of manufacturing will translate into costlier drugs.According to a recent report undertaken by RAND, prescription drug prices in the US are on an average 2.78 times those seen in 33 other nations. With tariffs, that gap will widen further.Drug supply chains are complex; moving capacities to US costly, time-consumingAccording to the US Food and Drug Administration (FDA), as of August 2019, only 28 percent of the facilities producing APIs for the US market were located domestically. The remaining 72 percent were overseas, with nearly half of its generics coming from India.The US is also highly dependent on drug imports for critical therapies. In 2024, the European Union supplied US$ 127 billion worth of high-value branded medicines to the US.The pharmaceutical supply chain is complex. There are a series of chemical steps involved in making any drug, with each step often being performed in different locations.The supply chain is determined by a variety of factors, such as availability of cheap labour, tax rates, supply of raw materials etc. For instance, Ireland has a very low corporate tax rate. Therefore, it has emerged as a hub for the production of APIs used in blockbuster medicines, such as Lilly’s Zepbound and Merck’s Keytruda.Moving production to the US will take five to seven years per plant. Each plant will cost US$ 2 billion or more. And it will have to go through several checks to meet America’s high regulatory standards. It is a long, arduous and unnecessary exercise, when capacities, expertise and cheaper labor is already existing in other countries.Europe also plans to onshore, leading to turbulent shift in trade dynamicsLike the US, Europe too is heavily reliant on China and India, and is working towards reducing its dependence. Over the years, Europe has moved significant resources into the US, especially in R&D. American drugmakers like Pfizer and Johnson & Johnson, on the other hand, manufacture many of their drugs in Europe and export them back to the US. Tariffs, therefore, will impact European exports in a big way. Drugmakers confronted European Commission President Ursula von der Leyen soon after Trump spoke about the pharma tariffs. These drugmakers, led by Novo Nordisk’s CEO Lars Fruergaard Jørgensen, asked for a “rapid, radical policy change” so that R&D and manufacturing doesn’t get directed towards the US.According to these drugmakers, up to 85 per cent of capital investments (about €50.6 billion, or US$ 56 billion) and up to 50 per cent of R&D expenditures (about €52.6 billion or US$ 58 billion) are potentially at risk. These figures are taken from a total of €164.8 billion (US$ 182 billion) worth of pharmaceutical investment planned in the EU during 2025 to 2029.Tariffs will test low margins of generics, may put a pause on dealmakingTariffs will have a different impact on generics. According to a Brookings report, while tariffs will “provide a strong incentive for increasing US manufacturing of brand-name drugs”, it will not be incentive enough for older, off-patent generic drugs, which “represent over 90 percent of the volume but only a small share of spending”.It will be difficult for generic drugmakers to onshore due to high capital expenditures and low and uncertain returns on investment. In fact, tariff pressure will test the wafer-thin margins of generic drugmakers in both the US and overseas. This could lead to product discontinuations or drastic cost cutting, which in turn could erode product quality.In the end, as Arthur Wong, senior director of corporate ratings, healthcare, at S&P Global Ratings, puts it, all this chaos is going to “put a pause [on] or distract” from another key pharma function: dealmaking. The time for executing M&As was now. But we can’t expect dealmaking to return until the second half of 2025.