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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

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7 FDA
1 GDUFA

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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.

CPhI WW FrankfurtCPhI WW Frankfurt

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28-30 October, 2025

Frankfurt
PREPPREP

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29 September-02 October, 2025

Philadelphia, PA, United States
OPRDOPRD

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29 September-01 October, 2025

Eurostars Universal Hotel

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601 Yellowstone Ave - Cody, WY 82414

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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: 2952

VLOG #PharmaReel

[Sponsored by another company]

Partner in End-to-End API Manufacturing

This PharmaReel showcases Coral Drugs, a global partner in end-to-end API manufacturing with more than 27 years of expertise. Supported by vertically integrated cGMP and ISO-compliant facilities, the company is backed by USFDA and EMA certifications, patents, and advanced micronization capabilities.

Impressions: 117

DATA COMPILATION #PharmaFlow

[Sponsored by another company]

Global API micronization market set to surge 49% by 2030, led by specialized industry pioneers

Precise particle size control has become the cornerstone of modern pharmaceutical manufacturing. With highly potent active pharmaceutical ingredients (HPAPIs) and complex formulations driving unprecedented demand, micronization technology is no longer optional — it's critical. The market reflects this urgency. The global API micronization market will jump from US$ 2.47 billion in 2024 to US$ 3.68 billion by 2030 — a 49 percent surge driven by a robust 6.84 percent CAGR. What's powering this growth? Strategic innovation by industry leaders. Companies like Munit SA, Lonza, Catalent, Veranova, EUROAPI, AGC Pharma Chemicals, Hovione and Coral Drugs aren't just participating — they're defining the future of pharmaceutical particle engineering. The Micronization Landscape: How leading companies are advancing pharmaceutical particle engineering The API micronization space is being shaped by companies with specialized expertise. Munit’s proprietary fluid jet milling technology brings particle sizes down to the 1-micron level — critical for inhalation therapies. In addition, this technology enables precise control over particle size distribution without mechanical impact, making it ideal for heat-sensitive and high-potency APIs. With decades of hands-on experience, Munit ensures batch-to-batch consistency, scalability from R&D to commercial volumes, and full compliance with GMP standards. Munit offers high-containment isolators — including glove boxes for R&D and half-suit isolators for larger batches — with industry-leading containment levels, limiting airborne drug exposure to as low as 0.025 micrograms per cubic meter. This makes it particularly well-suited for handling highly potent or sensitive compounds, exceeding the capabilities of other commercial-scale players like Catalent, who typically achieve containment levels of 0.05 micrograms per cubic meter or higher. EUROAPI has taken a broad particle engineering approach, offering both micronization and spray drying across multiple dosage routes — oral, inhaled, and parenteral. AGC Pharma Chemical leverages spray drying and amorphous solid dispersion technologies across small molecules, peptides, ADCs, and oligonucleotides, exemplifying the evolving intersection of particle engineering and modern drug delivery innovation. Coral Drugs delivers cutting-edge technology and customization capabilities that tailor particle sizes to specific client requirements across tablets, injectables, and topicals. This dynamic competitive landscape continues to evolve as companies expand capabilities and form strategic partnerships. This year, Dec Group announced the launch of their cutting-edge Micronization Suite, now operational in Brick, New Jersey, while Lonza joined the Centre for Continuous Manufacturing and Advanced Crystallisation, an international research hub, to develop innovative continuous processing and crystallization solutions. Selecting the right micronization partner: Key success factors In a pharmaceutical landscape increasingly defined by complexity, precision, and speed-to-market, the choice of a micronization partner can significantly influence a drug’s success. Among the players in this space, Munit SA has emerged as a trusted and strategic ally for pharmaceutical companies worldwide. But what exactly sets Munit apart in the micronization market? To begin with, Munit SA brings over 60 years of experience in particle size engineering. This legacy is not just a number; it reflects decades of accumulated knowledge, process refinement, and a deep understanding of how particle size impacts drug performance. In an industry where even minor deviations can compromise efficacy or safety, this level of experience is invaluable. It has delivered over 500 successful micronization projects to more than 150 customers globally. At its core, Munit SA is laser-focused on micronization and milling — not as ancillary services, but as its primary mission. Their facilities are designed for processing high-potency APIs, cytotoxic and cytostatic compounds, non-beta-lactam antibiotics, steroids, and controlled substances under stringent containment protocols. The company also handles inhalation products, peptides, biological drugs, generics, and R&D compounds. Whether it's micronization for ophthalmic formulations, transdermal or oral products, Munit offers a tailored approach. It stands as a world-leading provider of micronization services in inhalation powders with particle sizes of 1-5 microns and specialized oncology applications for small molecules. In an increasingly complex global landscape, Munit SA addresses supply chain challenges through its dual-site operational model, with facilities in Switzerland (Jetpharma SA) and Italy (Microchem S.r.l). This strategic setup mitigates risks from regulatory changes, geopolitical tensions, or environmental disruptions, ensuring continuous production and delivery of critical APIs. This resilience makes Munit a trusted partner for companies prioritizing business continuity. Why pharmaceutical companies choose Munit for advanced micronization and milling Munit’s proprietary MC Jet Mill is a testament to its engineering excellence. For heat-sensitive APIs, Munit’s cryogenic micronization process uses liquid nitrogen to cool materials, preventing thermal degradation and preserving the integrity of delicate molecules. This is particularly valuable for biologics and APIs with low melting points, where stability is paramount. Additionally, Munit’s under containment micronization employs advanced systems to safely handle HPAPIs, protecting both operators and the environment while meeting stringent regulatory standards. Their co-micronization service, which processes APIs alongside excipients, further enhances formulation stability and solubility, offering innovative solutions for complex drug profiles. These capabilities, executed under Good Manufacturing Practices (GMP), make Munit a reliable choice for pharmaceutical companies seeking precision and quality. While micronization is Munit’s flagship, it offers milling services through an array of technologies, each suited to specific needs. The Pin Mill uses a grinding chamber and particle size reduction is achieved due impact against a high-speed pin rotor, producing sizes from 50 to 150 microns. It’s particularly effective for APIs needing improved flow for tableting, offering precise size control that ensures uniformity. The Quadro Co-Mill excels at soft de-lumping and homogenization, using a conical sieve and impeller to gently process powders without altering primary particle sizes. For tougher materials, the HammerMill C-10 employs hammer bars on a rotor to crush particles. State-of-the-Art Particle Engineering: Munit's strategic innovation push delivers next-gen solutions Munit’s leadership in micronization is underpinned by a deliberate and sustained investment in innovation — aimed at building the next generation of particle size engineering. In response to client challenges with condensation and product degradation, Munit developed a proprietary conditioning system that precisely controls humidity and temperature. Engineered with ergonomic design and fluid dynamics principles, their machine represents a qualitative leap in conditioning. Munit's new AIFA-approved Building C transforms the Italian hub's capacity. Equipped for high potent, toxic, cytotoxic, and cytostatic compounds, alongside hormones, it features cutting-edge safety systems and integrated technologies, enabling broader API processing with precision and compliance. Munit has merged quality assurance and regulatory affairs into one strategic unit, streamlining workflows and enhancing client responsiveness during critical validation phases. This delivers tailored regulatory support and accelerates time-to-market. These initiatives position Munit at the forefront of particle size engineering, where state-of-the-art innovation, regulatory excellence, and client-centric design converge to set new industry standards. Our view The API micronization market is projected to grow 49 percent to US$ 3.68 billion by 2030. In this evolving landscape, companies that combine deep technical expertise with operational resilience are positioned to capture the greatest value. Munit SA exemplifies this winning formula.