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

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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

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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 North America CPhI North America

Not Confirmed

Not Confirmed

20-22 May, 2025

Pennsylvania Conv Center, Philadelphia
STLE Annual MeetingSTLE Annual Meeting

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Not Confirmed

18-22 May, 2025

Atlanta, Georgia
American Thoracic Soci...American Thoracic Society

Not Confirmed

Not Confirmed

18-21 May, 2025

San Francisco

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601 Yellowstone Ave - Cody, WY 82414

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(307)587-7099

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https://www.codylabs.com/

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INTERVIEW #SpeakPharma

[Sponsored by another company]

Alchem NicSelect™ grants customers royalty-free access to T-MAX™ tech for 3-in-1 vape satisfaction in flavour-restricted markets

With increasing flavour bans in key markets, vaping brands are facing significant challenges in providing satisfying alternatives to vapers and smokers looking to transition. Recognising this need, Alchem NicSelect™ is making a bold move by offering its key customers royalty-free and unrestricted geographical access to its revolutionary T-MAX™ technology.“At Alchem NicSelect™, we understand the urgency for vaping brands to adapt to new regulations without compromising on satisfaction. By offering royalty-free access to T-MAX™ technology, we empower our customers to provide the closest cigarette-like experience possible, even in markets with strict flavour restrictions,” said Riccardo Santambrogio, Europe Sales Manager.HIGHLIGHTS// offering royalty-free access to T-MAX™ technology/ unrestricted geographical access/ closest cigarette-like experience Addressing the biggest barrier: Nicotine satisfactionOne of the primary reasons many vapers are dissatisfied and smokers struggle to switch to vaping is that traditional nicotine solutions fail to replicate the rapid satisfaction provided by cigarettes. Nicotine replacement therapies (NRTs) and even conventional vaping products often lack the immediate nicotine hit, throat feel, and overall experience that smokers are accustomed to. T-MAX™ solves this problem by engineering a nicotine experience that closely mimics cigarette consumption without relying on flavours.T-MAX™ provides a unique 3-in-1 approach:1. The Speed of a Cigarette – Rapid nicotine delivery and rush within seconds for immediate satisfaction.2. The Power of Nicotine Salts – A stronger perceived nicotine effect without exceeding legal limits (20 mg/ml nicotine limit under the European Tobacco Products Directive). With T-MAX™, 8 mg/ml feels like 20 mg/ml, and 14 mg/ml feels like 40 mg/ml.3. The Throat Hit of Freebase Nicotine – Especially in a flavour-free formulation, the combined ingredients in T-MAX™ deliver an even more satisfying throat feel than expected from nicotine base, much closer to and more familiar with a cigarette throat feel that habitual smokers recognise.HIGHLIGHTS// unique 3-in-1 approach/ rush within seconds/ stronger perceived nicotine effect without exceeding legal limits/ more satisfying throat feel that habitual smokers recogniseNo flavour, but not less satisfyingWhile flavours have traditionally played a role in vaping adoption, market realities are shifting. With flavour bans spreading across regions, brands need solutions that deliver satisfaction without relying on taste. Consumer research has shown that T-MAX™ performs exceptionally well even without added flavours. Since most cigarette smokers do not smoke for the tobacco flavour but rather for the nicotine hit and habitual experience, T-MAX™ provides a viable alternative that aligns with new regulatory landscapes.HIGHLIGHTS// flavour bans spreading across regions/ T-MAX™ performs exceptionally well even without added flavoursEmpowering vape brands with free access to T-MAX™By granting customers royalty-free access to the T-MAX™ technology, Alchem NicSelect™ is removing barriers for vaping brands and original equipment manufacturers (OEMs) looking to adapt to regulatory changes. This open-access approach ensures that manufacturers can integrate T-MAX™ into their product lines without additional costs, allowing them to offer superior nicotine satisfaction in markets where flavours are no longer an option.HIGHLIGHTS// removing barriers for vaping brands and OEMs looking to adapt/ manufacturers can integrate T-MAX™ into product lines without additional costsThe future of vaping in restricted marketsWith T-MAX™, the vaping industry has a powerful tool to retain customers and convert smokers who have struggled with traditional vaping products. By delivering the key elements of cigarette satisfaction — without combustion or flavours — T-MAX™ is set to redefine what a satisfying vape experience means in a post-flavour-ban world.“Our commitment to innovation and accessibility means we are providing our customers with the solutions they need to navigate an evolving regulatory landscape. T-MAX™ allows brands to offer a highly satisfying experience that mimics smoking without relying on flavours. The message is clear: no flavour, but not less satisfying”, added Santambrogio.HIGHLIGHTS// powerful tool to retain customers and convert smokers/ delivering the key elements of cigarette satisfaction without combustion or flavours/ no flavour, but not less satisfying

Impressions: 284

VLOG #PharmaReel

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Connecting People, Mentalities & Markets

This PharmaReel highlights Transo-Pharm USA’s offerings of premium Phyto Cannabidiol (CBD) and Phyto Cannabigerol (CBG) isolates from its cGMP-certified facility inspected by the FDA and ANVISA. The company has an expanded reach across the US and EU.

Impressions: 402

DATA COMPILATION #PharmaFlow

[Sponsored by another company]

DMF filings surge 44% in Q1 2025; India tops list with 51% rise in year-on-year submissions

The first quarter (Q1) of 2025 witnessed an impressive surge in Drug Master File (DMF) submissions to the US Food and Drug Administration (FDA), signaling a robust expansion in pharmaceutical development activities, the looming threat of tariffs notwithstanding.A total of 339 Type II DMFs were submitted during this period, as opposed to 235 submissions in Q1 2024, marking an exceptional increase of 44.26 percent. PharmaCompass’ data suggests that this is a record high for any first quarter.Overall, 440 DMFs were submitted across all categories (Types II, III, IV, and V) during Q1 2025, compared to 353 in the same period last year — representing a 24.65 percent increase.India and China continued to dominate the DMF landscape. India led with 162 submissions in Q1 2025, posting a remarkable 51.4 percent increase over 107 submissions recorded in Q1 2024. China followed with 135 submissions, representing a 33.66 percent increase over the 101 filings in Q1 2024.Taiwan sprung a surprise as a distant third. It made 12 DMF submissions in Q1 2025, as opposed to just one in Q1 2024. Western countries like the US, Spain, Germany, and Italy have maintained relatively stable or declining submission rates. Only the Netherlands showed significant growth with four DMF submissions in Q1 2025, up from zero in Q1 2024. View FDA DMF Filings in Q1 2025 (Power BI Dashboard, Free Excel Available)Indian giants MSN, Aurobindo, Cipla, Dr Reddy’s lead record-breaking DMF surgeIndia lived up to its “pharmacy of the world” reputation with the highest DMF submissions. In fact, seven of the top eight companies in the DMF tally were headquartered in India. MSN Group, emerged as the unequivocal leader with 23 submissions in Q1 2025, as against 15 in Q1 2024. Aurobindo Pharma increased its DMF activity from seven submissions in Q1 2024 to 12 in Q1 2025. Alivus Life Sciences, formerly known as Glenmark, made a dramatic leap with eight submissions in Q1 2025, quadrupling its previous year’s count of just two. Cipla more than doubled its DMF submissions — from three in Q1 2024 to eight in Q1 2025.Dr. Reddy’s Laboratories, one of India’s largest generic drugmakers, filed seven DMF submissions. The company’s Q1 2025 DMF portfolio includes high-value molecules like deucravacitinib, finerenone, enzalutamide, niraparib tosylate monohydrate, tucatinib, and tizanidine hydrochloride.Dr. Reddy’s has also indicated that they are open to manufacturing in the US. Meanwhile, Hetero Drugs filed seven submissions while Lee Pharma recorded six in Q1 2025.Chinese manufacturer Jiangsu East-Mab Biomedical Technology also established a significant presence with six DMFs. View FDA DMF Filings in Q1 2025 (Power BI Dashboard, Free Excel Available) Semaglutide, finerenone see most DMF submissions; first-time filings surge 64%Semaglutide and finerenone emerged as the most documented molecules in Q1 2025, each garnering nine DMF submissions. Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist that has revolutionized diabetes management and weight loss treatment, continues to attract significant manufacturer interest. Similarly, finerenone, a non-steroidal drug used in treating chronic kidney disease in type 2 diabetes patients, has garnered attention from manufacturers.Carfilzomib, used in multiple myeloma treatment, secured the third position with five DMF submissions. Deucravacitinib, a novel drug approved for moderate to severe plaque psoriasis, followed with four DMF submissions.There were several molecules with three DMF submissions each. Among them were tapinarof, a novel drug for psoriasis, and tirzepatide, a GLP-1/GIP receptor agonist that has shown remarkable efficacy in diabetes and weight management. During the quarter, 23 molecules received their inaugural DMF submissions. This number has risen by 64 percent since Q1 2024, when only 14 drugs saw their first DMF filings.In Q1 2025, these 23 first-time molecules collectively garnered 30 DMF submissions, with deucravacitinib emerging as the clear leader. Indian companies Dr. Reddy’s Laboratories and Cipla filed DMFs for this plaque psoriasis treatment as did Spain’s Curia and PMC Global.The Q1 2025 roster of first-time DMF filings include retatrutide (another GLP-1 receptor agonist), sotagliflozin, setmelanotide acetate, daridorexant, nusinersen, zavegepant, belzutifan, elacestrant dihydrochloride, selumetinib sulfate, sotorasib, atogepant, omadacycline tosylate, osilodrostat phosphate, ensifentrine, landiolol hydrochloride, maralixibat chloride, maribavir, methyl olivetolate, diazoxide choline, sparsentan, thinnertide, and vismodegib. View FDA DMF Filings in Q1 2025 (Power BI Dashboard, Free Excel Available) Our viewGiven Trump’s rhetoric around tariffs on imported drugs, the record-breaking DMF submissions in Q1 2025 sent out a strong message that the global pharmaceutical industry is willing to take on the complex geopolitical situation with resilience and strategic foresight.On a different note, the rise in DMF filings also indicate increased workload for the FDA staff, as also more inspections by the agency. It seems like more ‘laid off’ FDA employees will be asked to return to work in the coming days.