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

AMI Lifesciences is Driven by Chemistry. Powered by People.

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 WW FrankfurtCPhI WW Frankfurt

Not Confirmed

Not Confirmed

28-30 October, 2025

Frankfurt
Coatings TrendsCoatings Trends

Not Confirmed

Not Confirmed

03-05 September, 2025

The Westin Lombard, IL
iPHEX IndiaiPHEX India

Not Confirmed

Not Confirmed

04-06 September, 2025

Bharat Mandapam, New Delhi

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]

"50 Years of Innovation: Mikart's legacy and what's next in CDMO excellence"

This week, SpeakPharma interviews Michael Kallelis, CEO of Mikart, a leading contract development and manufacturing organization (CDMO) celebrating its 50th anniversary in the pharmaceutical industry. Based in the United States, Mikart has built a reputation for technical expertise, flexible business terms, and specialized capabilities in pharmaceutical development services. In this exclusive interview, Kallelis discusses how Mikart maintains its competitive edge through its Pharmaceutical Development Services team, quality control framework, and commitment to customized business solutions. Kallelis also explores the company's focus on liquid suspensions manufacturing, driven by growing demand from aging populations and pediatric patients, and explains how Mikart balances traditional family business values with modern innovation. HIGHLIGHTS// celebrating its 50th anniversary/ reputation for technical expertise/ how Mikart maintains its competitive edge Mikart is celebrating 50 years in business this year — what are some of the major milestones that have shaped the company's journey? Over our 50-year history, we've celebrated many memorable milestones, but one of the most significant in recent years has been achieving our growth objectives. This success was driven by the strategic expansion of our Pharmaceutical Development Services team, the completion of full aggregate serialization in our packaging department, modernization of our IT systems, enhanced productivity, and our ability to attract both new and returning customers. HIGHLIGHTS// expansion of our Pharmaceutical Development Services team/ completion of full aggregate serialization/ attract both new and returning customers How has Mikart maintained its competitive edge in a constantly evolving pharmaceutical landscape? Our customers consistently tell us that what sets us apart is our technical expertise, high service level, and flexible, customized business terms. At the core of our competitiveness is our focus on Pharmaceutical Development Services (PDS). Mikart's PDS opinion leaders are actively engaged in business development and form early, collaborative relationships with our customers' technical teams. From the outset, our prospects and clients work directly with Mikart's experienced formulation chemists, analytical method developers, and process-oriented engineers to design robust, reproducible, and efficient processes. This hands-on development approach is supported by a comprehensive quality control testing framework — covering raw material testing, in-process checks, on-site microbiological testing, and in-house stability studies. Oversight is provided by our robust Quality Management System, managed by a dedicated Quality Assurance and Regulatory Affairs team. The result is disciplined problem-solving, timely FDA submissions, and a "right-first-time" philosophy that accelerates time-to-market. We operate with a strong sense of urgency and consistently deliver a high level of customer satisfaction. What truly differentiates Mikart is our commitment to customized business terms that eliminate common roadblocks seen with other CDMOs. Our secret sauce is our exceptional service and flexibility in helping our customers bring innovative medicines to patients. HIGHLIGHTS// technical expertise, high service level/ flexible, customized business terms/ comprehensive quality control testing framework/ dedicated Quality Assurance and Regulatory Affairs team/ timely FDA submissions/ accelerates time-to-market What capabilities or services does Mikart offer today that didn't exist 10 or 20 years ago? Mikart was an early leader in serialization, implementing full capabilities well ahead of the industry timeline. This proactive approach has kept our packaging team in high demand. We also upgraded our tablet compression equipment to enhance both speed and reliability. To support growing development needs, we invested in new lab-scale development equipment, unit dose cup filling, sachet packaging, low-humidity suites, and a brand-new suite dedicated to closed-system manufacturing of liquids and suspensions. Most recently, we launched a multi-million dollar expansion of our packaging lines to support higher-speed tablet filling, powder-in-bottle formats, and new liquid fill capabilities. HIGHLIGHTS// early leader in serialization/ upgraded our tablet compression equipment/ multi-million dollar expansion of our packaging lines Why are liquid suspensions becoming such a key focus, and how is Mikart positioned? Formulating suspensions is a complex process that requires specialized expertise and equipment. According to our customers, few mid-market CDMOs do it well — and Mikart is one of them. There is growing industry demand for high-quality suspension manufacturing, driven by the needs of the aging baby boomer population and pediatric patients. For both groups, swallowing tablets or capsules can be difficult, making oral liquid suspensions a more practical alternative. In addition to being easier to administer, suspensions offer pharmacological advantages and can improve dosing compliance. Enhanced flavoring techniques further improve the patient experience — especially for children and infants — by making medicines more palatable. HIGHLIGHTS// growing industry demand for high-quality suspension manufacturing/ suspensions offer pharmacological advantages/ improve dosing compliance How does Mikart balance tradition with innovation to meet modern customer demands? At Mikart, we work hard to preserve the values of a traditional family business, even as we continue to modernize. Our goal is to make every customer feel like they are our top priority. Each customer is supported by a dedicated project manager who serves as their primary point of contact, along with direct access to key team members across departments. This structure ensures our customers are never isolated from our subject matter experts and can get timely, accurate answers to their questions. We're also mindful of the "technology trap" — the tendency to pursue every new innovation at the expense of focus and efficiency. Instead, we rely on market data and customer trends to guide our investments, enabling us to concentrate our resources and capital on technologies that meet real market needs. HIGHLIGHTS// customer is supported by a dedicated project manager/ customers are never isolated from our subject matter experts/ we rely on market data and customer trends to guide our investments/ meet real market needs Looking ahead, what's in store for Mikart in the next 5-10 years? Mikart's strategic plan is now in full motion, and with the momentum we've built, 50 percent growth is within reach. This projection is backed by a strong pipeline of annual FDA filings, a growing customer base, and a robust portfolio of active Pharmaceutical Development Services projects. As we grow, we remain committed to delivering exceptional service and continuously evolving to meet the changing needs of our customers. With renewed political emphasis on domestic manufacturing for the US market, we are ideally positioned to support the rapid, cost-effective development and production of high-quality medicines here at home. As we approach our 50th anniversary in the CDMO industry, we celebrate our legacy and look forward with optimism to the opportunities ahead in the next 5 to 10 years. HIGHLIGHTS// 50 percent growth is within reach/ strong pipeline of annual FDA filings

Impressions: 2652

VLOG #PharmaReel

[Sponsored by another company]

Versatile Source for Prostaglandin APIs

This PharmaReel spotlights Cayman Pharma’s expertise in Prostaglandin APIs, backed by Czech NCA (SUKL, USKVBL) and USFDA approvals. With patented technology, process excellence, and quality focus, Cayman is a trusted partner for reliable CDMO services.

Impressions: 7941

DATA COMPILATION #PharmaFlow

[Sponsored by another company]

FDA approvals drop 24% in H1 2025; GSK’s UTI med, Vertex’s non-opioid painkiller lead pack of first-in-class meds

It has been a turbulent year for the US Food and Drug Administration (FDA), marked by reductions in both staff and budget, shake-ups at the top and a reduction in inspections. This upheaval has clearly impacted the functioning of the agency, with reports of missed deadlines and reduced responsiveness. This disruption resulted in a slowdown in new drug approvals in the first half of 2025 (H1 2025), as opposed to the same period last year. Incidentally, drug approvals in H1 2024 were also down by 19 percent compared to H1 2023. FDA’s Center for Drug Evaluation and Research (CDER) approved 16 novel drugs in H1 2025, down from 21 in H1 2024, a decline of nearly 24 percent. Of these, nine were small molecules and seven were biologics. The period saw eight first-in-class therapies get CDER’s approval, as opposed to 17 in H1 2024. FDA’s Center for Biologics Evaluation and Research (CBER) approved seven biologics in H1 2025, compared to eight in the same period last year. In comparison, both Health Canada and the European Medicines Agency (EMA) reported a strong rebound in approvals and authorizations, respectively. Health Canada approved 20 drugs in H1 2025, as opposed to 10 in H1 2024. Similarly, EMA authorized 19 new therapies in H1 2025, compared to 15 in H1 2024. Notably, EMA’s pending decisions increased to 25 in H1 2025, from 14 in the same period last year, while conditional authorizations remained static at five. This underscores EMA’s active regulatory pipeline, suggesting that more drugs could be approved in Europe soon. View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available) Vertex’s non-opioid painkiller, GSK’s antibiotic for UTI, Merck’s RSV antibody bag FDA nods Oncology remained the single largest category in H1 2025 with seven new drugs being approved by the FDA, followed by four rare diseases and disorders and as many infections and infective diseases. The eight drugs that were designated first-in-class in H1 2025 are: Journavx (Suzetrigine), Imaavy (nipocalimab), Emrelis (telisotuzumab vedotin), Blujepa (gepotidacin mesylate), Qfitlia (fitusiran), Avmapki Fakzynja Co-Pack (avutometinib potassium/defactinib hydrochloride), Tryptyr (acoltremon), and Andembry (garadacimab). In January, a new class of non-opioid pain therapy made a debut — FDA approved Vertex Pharmaceuticals’ Journavx (suzetrigine). This first-in-class oral analgesic could bring in US$ 2.9 billion in sales for Vertex by 2030. The half year also saw a new oral antibiotic — GSK’s Blujepa (gepotidacin) — for treating uncomplicated urinary tract infections (uUTIs) bag FDA approval. This is the first new antibiotic for uUTIs in nearly three decades. It treats infections caused by resistant pathogens such as E. coli and K. pneumoniae. In June, Merck’s Enflonsia (clesrovimab), a long-acting monoclonal antibody, won FDA approval to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants entering their first RSV season. A single 105 mg dose provides protection for about five months, the length of a typical RSV season. Enflonsia could bring in US$844 million in annual sales by 2030. View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available) FDA approves four meds for rare diseases, including SpringWorks’ Gomekli, Novartis’ Vanrafia In H1 2024, rare genetic diseases had witnessed some significant approvals. The trend continued in H1 2025. In February, Gomekli (mirdametinib), developed by SpringWorks Therapeutics, became the first approved therapy for neurofibromatosis type 1 (a genetic disorder that causes tumors to grow on nerve tissues) in adult and pediatric patients who have symptomatic plexiform neurofibromas (benign, complex nerve tumors) not amenable to complete resection. Analysts expect peak sales of around US$ 0.8 billion by 2030. Post this approval, SpringWorks got acquired by Merck KGaA for approximately US$ 3.9 billion. The same month, Ono Pharma-owned Deciphera’s Romvimza (vimseltinib) became the first oral therapy approved for another rare disease known as symptomatic tenosynovial giant cell tumor. This is a benign but aggressive growth that can be painful. This new drug offers patients an option beyond surgery. In March, Sanofi’s Qfitlia (fitusiran) was approved for routine prophylaxis in hemophilia A or B, with or without inhibitors. And in April, Novartis’ Vanrafia (atrasentan) was granted accelerated approval for IgA nephropathy (a chronic autoimmune kidney disease), which is at the risk of rapid progression. Vanrafia could bring in sales of over US$ 735 million by 2030. Johnson & Johnson secured approval for Imaavy (nipocalimab-aahu) for generalized myasthenia gravis (a chronic autoimmune disease that causes muscle weakness) in adults and adolescents. Imaavy’s sales could cross US$1.17 billion by 2030. Rare diseases continue to attract regulatory attention, with the trend carrying into the current quarter. July witnessed two noteworthy rare-disease approvals — Ekterly (garadacimab), CSL’s once-monthly prophylactic treatment for hereditary angioedema (a genetic disorder that causes recurrent episodes of swellings), and Sephience (pegvaliase-abcx), BioMarin’s new therapy for phenylketonuria (a rare metabolic disorder). View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available) FDA greenlights new oncology therapies, including Astra’s Datroway, AbbVie’s Emrelis The field of oncology saw some notable new drug approvals. In January, Datroway (datopotamab deruxtecan), an antibody-drug conjugate (ADC) developed by AstraZeneca and Daiichi Sankyo, was granted approval for adults with unresectable or metastatic, hormone receptor-positive, HER2-negative breast cancer. Later, in June, the FDA granted accelerated approval to AstraZeneca;s Datroway for adults with locally advanced or metastatic, EGFR-mutated non-small cell lung cancer. The drug’s peak annual sales are projected at about US$ 4.2 billion by 2030. In May, Emrelis (telisotuzumab vedotin-tllv), AbbVie’s ADC was granted FDA’s accelerated approval. Emrelis treats locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) characterized by significantly increased levels of the c-Met protein in cancer cells. FDA also approved a companion diagnostic test — Roche's Ventana — in May to determine the c-Met protein biomarker status in order to identify patients eligible for Emrelis. The same month, FDA also granted accelerated approval to Verastem’s Avmapki Fakzynja Co-pack, a dual oral therapy for adults with KRAS‑mutated recurrent low‑grade serous ovarian cancer (LGSOC). This novel regimen combines two inhibitors — avutometinib and defactinib — to disrupt critical signaling pathways that fuel tumor growth. In ophthalmology, Alcon re-entered the prescription pharmaceutical market with Tryptry (acoltremon), a first-in-class TRPM8 agonist for dry eye disease, which stimulates corneal nerves to increase tear production. View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available) Our view The changes in the FDA are clearly having a far-reaching impact on the global pharmaceutical industry. There have been reports of drugmakers losing confidence in the FDA, which has been a gold standard for drug regulation. Some American biotechs are shifting early trials outside of the US. With EMA and Health Canada authorizing/approving a larger number of drugs in H1 2025, we do see some changes underway that may eventually reshape drug development.