MIKART DMF, CEP, Written Confirmations, FDF, Prices, Patents, Patents & Exclusivities, Dossier, Manufacturer, Licensing, Distributer, Suppliers, News, GMP

Mikart Supports Cannabinoid & Psilocybin Drug Development

18 Apr 2025

// PRESS RELEASE

Liquid Suspension Trends in the CDMO Space

21 Feb 2025

// PRESS RELEASE

Mikart Celebrates 50 year of Excellence in Pharma Manufacturing

16 Jan 2025

// PRESS RELEASE

DATA COMPILATION
#PharmaFlow

Contact Supplier

Website

Contract Pharma

Attending

Book a meeting

envelop Contact Supplier

DIGITAL CONTENT

1 Interview #SpeakPharma, 9 Corporate Content #SupplierSpotlight, 1 Company Bio #AboutSupplier, 2 Data Compilation #PharmaFlow, 21 News #PharmaBuzz

media
1 Interview #SpeakPharma
9 Corporate Content #SupplierSpotlight
1 Company Bio #AboutSupplier
2 Data Compilation #PharmaFlow
21 News #PharmaBuzz

FINISHED DOSAGE FORMULATIONS

57 FDF Dossiers, 57 FDA Orange Book

57 FDF Dossiers
57 FDA Orange Book

SERVICES

Analytical, Drug Product Manufacturing, API & Drug Product Development, Packaging

pharmaServices
Analytical
- 1 Analytical Method Development
Drug Product Manufacturing
API & Drug Product Development
- 1 Preformulation & Material Science
- 12 Formulation Development
Packaging
- 3 Clinical Services
- 6 Contract Services

KEY SERVICES

Immediate & Controlled Release Capsules, Non-sterile Liquid Manufacturing, Immediate & Controlled Release Tablets, Clinical Supply of Tablets, CDMO for Controlled Substance Capsules, Clinical Supply of Capsules, Orodispersible Tablet Manufacturing, Chewable Tablet Contract Manufacturing, Controlled Substance Formulations, Clinical Supply of Oral Liquids, CDMO for Tablets, Hard Capsule Contract Manufacturing, CDMO for Controlled Substance Liquids, Film & Enteric Coated Tablets, Extended Release Tablet Manufacturing, CMO for Sustained Release Tablets, Contract Manufacturing for Tablets, ODT Contract Manufacturing, CMO for Capsules, CDMO for Controlled Substance Tablets

INSPECTIONS & REGISTRATIONS

14 FDA, 1 GDUFA

inspections
14 FDA
1 GDUFA

As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.

About

Mikart is a privately owned contract development and manufacturing organization (CDMO) that has consistently delivered top-notch products for over 50 years. Mikart’s capabilities span across various areas, such as product development, regulatory services, clinical trial supplies, analytical services, solid or liquid oral dose manufacturing and packaging. Mikart's specialty lies in non-sterile oral liquid and oral solid dosage forms, particularly in controlled substances, geriatrics and pediatrics, from formulation to full-scale commercialization. Mikart adheres to all current FDA and cGMP standards to ensure top-quality output.

Contract PharmaContract Pharma

Industry Trade Show

Attending

18-19 September, 2025

Hyatt Regency New Brunswick, NJ
CPhI WW FrankfurtCPhI WW Frankfurt

Industry Trade Show

Attending

28-30 October, 2025

Frankfurt
APGA Annual ConferenceAPGA Annual Conference

Industry Trade Show

Not Confirmed

20-23 July, 2025

Traverse City, MI

CONTACT DETAILS

Click the arrow to open the dropdown

Country

U.S.A

Address

1750 Chattahoochee Ave. Atlanta, GA 30318

Telephone

+1 8884645278

bizdev@mikart.com

Website

https://www.mikart.com/

https://www.linkedin.com/company/mikart-llc/

YouTube

Digital content

Explore the latest content creation from this company

INTERVIEW #SpeakPharma

"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: 61

CORPORATE CONTENT #SupplierSpotlight

Corporate Presentation

Open PDF

Upload

DEA Benefit of Partnering with Mikart CDMO

Serialization

Packaging Solutions

Manufacturing Services

Open PDF

Upload

Clinical Trial Labeling, Packaging & Manufacturing

Analytical Services

TrackWise Digital eEQMS

Open PDF

Upload

Corporate Video

DATA COMPILATION #PharmaFlow

CDMO Activity Tracker: Veranova, Carbogen lead ADC investments; Axplora, Polfa Tarchomin, Famar expand European footprint

During the second quarter (Q2) of 2025, contract development and manufacturing organizations (CDMOs) made substantial investments in specialized therapeutic manufacturing. The quarter also saw CDMOs pursue high-value, complex manufacturing niches, particularly in antibody-drug conjugates (ADCs), cell and gene therapies (CGTs) and oligonucleotides.Alongside these trends, Q2 also saw CDMOs strengthen their footprint in the United States amid concerns over rising tariffs and unpredictable trade policies being enforced by the Trump administration.Regeneron Pharmaceuticals committed over US$ 3 billion through a 10-year agreement with Fujifilm Diosynth Biotechnologies to nearly double its US manufacturing capacity for biologics. Under this agreement, Fujifilm will manufacture and supply drug products for Regeneron at its large-scale facility in Holly Springs, North Carolina.Thermo Fisher Scientific announced plans to invest an additional US$ 2 billion in the US over four years, reinforcing its manufacturing and R&D capabilities. With 64 facilities spread across 37 states, Thermo Fisher aims to bolster American innovation and competitiveness. Similarly, Piramal Pharma announced a US$ 90 million investment plan for expanding two facilities in the US, thereby bringing its total investment in the country to US$ 570 million. View CDMO Activity Tracker for Q2 2025 (Free Excel Available)Veranova, Carbogen lead ADC wave; Axplora doubles down on HPAPI production in ItalyThe quarter saw substantial investments in ADC manufacturing. Veranova announced a US$ 20 million investment in bioconjugation development and cGMP manufacturing capacity at its Devens, Massachusetts campus. With this investment, Veranova will be able to provide a more comprehensive suite of services to its partners developing ADCs and other bioconjugates. Veranova’s total investment in the Devens facility now stands at over US$ 50 million. Swiss CDMO Carbogen announced a US$ 31 million co-investment with an unnamed Japanese investor to expand its capabilities across its Aarau and Neuland (Switzerland) facilities. The facility will address increasing demand for complex and high-value compounds such as ADC drug linkers.Axplora announced a further €35 million (US$ 41 million) expansion of its Farmabios site in Italy, doubling the facility to approximately 108,000 square meters by mid-2026. This investment raises its total spend on the site to over €80 million (US$ 94.05 million) since 2019, supporting the production of highly potent active pharmaceutical ingredients (HPAPIs). Farmabios now stands as a key hub in Axplora’s global CDMO network.Polish pharmaceutical manufacturer Polfa Tarchomin is positioning itself as a significant player in the European CDMO market through its investment in the Center for Development and Production of Highly Potent Drugs. This 12,000 square meter facility has two state-of-the-art production lines designed for filling vials and pre-filled syringes with an annual capacity of 26 million product units.Skyepharma’s projected annual revenues from oncology-linked activities touched €10 million (US$ 11.2 million). The CDMO’s facility in Saint-Quentin-Fallavier is equipped to handle cytotoxic and cytostatic compounds, and is one of the few facilities in France capable of managing HPAPIs for oral anticancer treatments. View CDMO Activity Tracker for Q2 2025 (Free Excel Available) Athena acquires Medipha Santé, Famar buys MiP Pharma’s German site to strengthen European footprintDuring the quarter, several CDMOs enhanced their strategic capabilities through M&As. Athena Pharmaceutiques acquired Medipha Santé to build a fully integrated pharmaceutical services platform in Europe. Based in Paris, Athena has strengthened its commercial and regulatory toolbox by bringing aboard Medipha Santé’s 35-strong team, which supports over 100 partner organizations and files approximately 350 dossiers annually with ANSM and other European agencies. With this integration, Athena positions itself as a one-stop CDMO partner.With the acquisition of MiP Pharma’s sterile manufacturing site in Homburg, Germany, the Famar Group has expanded its capabilities in aseptic and lyophilized fill-and-finish operations. The acquisition has strengthened Famar’s position in sterile drug manufacturing. The CDMO now has seven manufacturing facilities in Europe.PCI Pharma Services’ acquisition of Ajinomoto Althea has established a world-class, large-scale manufacturing hub in the San Diego region with state-of-the-art aseptic facilities for prefilled syringes, cartridges and high-potent formulations such as ADCs. PCI Pharma is now amongst the few US-based CDMOs capable of comprehensive ADC manufacturing.Samsung Biologics’ strategic spinoff of its biosimilar business stood out as a significant corporate restructuring exercise during the quarter. The separation of Samsung Bioepis, tentatively renamed Samsung Epis Holdings, aims to enhance Samsung Biologics’ strategic focus and build client trust, as it eliminates potential conflicts between CDMO services and proprietary drug development. The move came after Samsung Biologics inked a contract worth 737.3 billion Korean won (US$ 518 million) with an undisclosed US pharmaceutical company.WuXi Biologics announced a US$ 167 million divestment of its German facility to Terumo and broke ground on a microbial production plant in China. National Resilience, which was launched five years ago as the US drug manufacturer dedicated to broadening access to medicines and protecting biopharma supply chains, said it is shuttering six of its 10 facilities. The company said the sites were “not being fully utilized.” View CDMO Activity Tracker for Q2 2025 (Free Excel Available) MilliporeSigma, Simtra form 5-year ADC alliance; Silexion partners Catalent for siRNA developmentMerck KGaA’s MilliporeSigma and Simtra struck a five-year strategic alliance, combining expertise across the ADC value chain to reduce development timelines and complexity for biopharmaceutical companies. Viralgen collaborated with Trogenix to rapidly scale product supply for TGX-007, an AAV gene therapy for glioblastoma (a type of cancer of the brain and spinal cord). Silexion announced a collaboration with Catalent for small interfacing RNA (siRNA) development and manufacturing. Catalent’s Limoges (France) facility will conduct formulation development and clinical manufacturing for Silexion’s SIL204 candidate, supporting both systemic and intra-tumoral delivery formulations.Skyepharma’s collaboration with Eneapharm through the Skyehub platform aims to support the treatment of patients suffering from exocrine pancreatic insufficiency, including those affected by cystic fibrosis or pancreatic cancer. Orion Corporation reached an agreement with Shilpa Biocare for the distribution of recombinant human albumin in Europe.Meanwhile, Aenova announced the launch of its Aenovation program, an initiative designed to fast-track early development of pharmaceutical formulations. The program addresses the critical challenges of bioavailability and time-to-market faced by poorly soluble drug candidates. View CDMO Activity Tracker for Q2 2025 (Free Excel Available) Our view The quarter saw CDMO developments mimic the broader trends in the pharmaceutical industry, such as onshoring of critical manufacturing capabilities in the US, consolidation of specialized expertise through strategic partnerships, and the relentless focus on emerging therapeutic modalities that promise to transform patient care. With CDMOs continuing to invest in next-generation manufacturing capabilities, we expect the sector to play a crucial role in drug innovation.

Impressions: 1235

CDMO Activity Tracker: Bora, PolPharma make acquisitions; Evonik, EUROAPI, Porton announce technological expansions

The contract development and manufacturing organization (CDMO) space continued to grow at an impressive pace in the second half (H2) of 2024, with significant progress being made across cell and gene therapies (CGTs), antibody-drug conjugates (ADCs), novel drug modalities, and digital solutions.Some of the key players in the CDMO space include Lonza, EUROAPI, Evonik, SEQENS, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Axplora, PolPharma, and Famar from Europe; Mission CDMO, LGM Pharma, Veranova, and Thermo Fisher from the US; and Samsung Biologics, Bora Pharmaceuticals, and Porton Pharma Solutions from Asia. Texas-based Mission CDMO has been in the pharma industry for over 75 years. Today, it is known for its comprehensive contract services and high-quality manufacturing capabilities that have reinforced its position as a trusted partner. View CDMO Activity Tracker for H2 2024 (Free Excel Available)Bora, PolPharma drive CDMO acquisitions; Samsung Biologics clocks over US$ 4 bn in contract valueThe second half of 2024 saw several high-value acquisitions and expansions that reshaped the CDMO landscape. South Korea-based Samsung Biologics clocked a cumulative contract value of over US$ 4 billion. It signed its largest manufacturing deal with an Asia-based pharmaceutical company, valued at US$ 1.24 billion. It also announced a series of manufacturing deals with a European drugmaker worth over US$ 668 million. Samsung Biologics is also building a dedicated ADC facility that is likely to be complete soon. Taiwan’s largest CDMO, Bora Pharmaceuticals, announced its second acquisition of the year. It bought New Jersey-based Pyros Pharmaceuticals, a developer of rare disease treatments. Pyros recently launched Vigafyde, the only ready-to-use vigabatrin oral solution and the first new product approved to treat infantile spasms in 15 years. Bora also announced a strategic investment in Tanvex Biopharma, thereby creating a global platform for biologics development and supply.PolPharma acquired Ziołolek, a renowned manufacturer of dermatological products, medical devices, and OTC medicines, thereby expanding its product portfolio. It also launched a state-of-the-art HPAPI (highly potent active pharmaceutical ingredients) facility in Poland, which is being seen as another step towards securing Europe’s drug supply chain.In other developments, Avid Bioservices got acquired by funds managed by Ampersand and British healthcare investment firm GHO Capital Partners in an all-cash deal worth US$ 1.1 billion. And Agilent Technologies agreed to acquire Canadian specialty CDMO Biovectra for US$ 925 million, thereby enhancing its capabilities in gene-editing technologies and sterile fill-finish services. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Evonik, EUROAPI, Porton Pharma, GSK announce tieups, technological expansionsSeveral CDMOs announced new collaborations and acquired new capabilities to enhance their service offerings. Evonik expanded its formulation capabilities for lipid nanoparticles used for mRNA and gene therapies through a collaboration with KNAUER Wissenschaftliche Geräte. This partnership aims to expand Evonik’s portfolio of biosolutions.Evonik is also restructuring its keto and pharma amino acid business to focus on strategic core growth areas. Evonik launched Eudracap colon functional capsules for targeted delivery of oral drugs. These ready-to-fill capsules are designed to release their contents specifically in the colon, improving the efficacy of treatments for various gastrointestinal conditions. Evonik also opened a new facility for drying aqueous dispersions of Eudragit polymers in Darmstadt, Germany. This facility will enhance Evonik’s capabilities in producing high-quality polymers for pharmaceutical applications.EUROAPI launched a new AI-powered Electronic Batch Record solution in collaboration with Aizon to enhance manufacturing productivity. This collaboration aims to digitize operations towards more data-driven manufacturing, focusing on small-scale productions and highly flexible plants.Porton Pharma Solutions has expanded its reach through several strategic initiatives. In October, Porton entered into a partnership with Shanghai InnoStar to enhance its service offerings beyond small molecules, targeting peptides, oligonucleotide drugs, conjugated drugs, and advanced therapies. It continued to grow its capabilities by enhancing its GMP manufacturing capacity in Fengxian, Shanghai (China). The facility’s expansion is aimed at increasing the production of novel therapies, including peptides and oligonucleotide drugs. These moves are part of Porton’s broader strategy to position itself at the forefront of advanced pharmaceutical manufacturing.Corden Pharma is investing € 900 million (US$ 985 million) over the next three years to expand its peptide platform facilities in Colorado (US) and Europe. While the US site will help meet the rising demand for GLP-1 peptides, in Europe, CordenPharma will construct a greenfield facility for small to large-scale peptide development and manufacturing.CDMO Touchlight signed a licensing agreement with GSK that grants the drug behemoth non-exclusive rights to use Touchlight’s proprietary enzymatic doggybone DNA (dbDNA) technology for the development and production of mRNA-based products, particularly vaccines. Curia also integrated enzymatic dbDNA solutions through a collaboration with Touchlight, enhancing mRNA production for vaccine and cancer therapies. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Lonza, Merck, Dr. Reddy’s owned Aurigene invest in cell and gene therapiesThe CGT space continued to draw both deals and investments. Lonza and Vertex signed a long-term commercial supply agreement for Casgevy, the world’s first CRISPR/Cas9 gene-edited cell therapy, to treat sickle cell disease and beta thalassemia. This agreement includes manufacturing at Lonza’s Geleen (the Netherlands) cell therapy manufacturing facility, with plans to expand to Portsmouth, New Hampshire (US).Miltenyi Biotec began manufacturing lentiviral vectors for Adaptimmune’s Tecelra, the first engineered TCR T-cell therapy for the rare soft tissue cancer synovial sarcoma approved by the US Food and Drug Administration.Merck KGaA commenced commercial production at its first GMP-compliant manufacturing line for cell culture media (CCM) in China. This facility addresses the growing local demand for quality custom CCM used in biopharmaceuticals, vaccines, and novel therapeutics.Aurigene and Edity Therapeutics announced a strategic collaboration in cell therapy, with Aurigene providing cell therapy discovery services to support Edity’s clinical development. Additionally, Aurigene and its parent, Dr. Reddy’s Laboratories, signed a memorandum of understanding (MoU) with Kainomyx for the development and commercialization of an affordable anti-malarial drug. ProBio and UCI Therapeutics signed an MoU for a comprehensive collaboration in gene delivery technologies, including viral and non-viral approaches. Additionally, Korea’s VaxCell-Bio partnered with ProBio to accelerate the development of its chimeric antigen receptor (CAR)-related therapies.The ADC market continued to be a hotbed of innovation and strategic expansion. Merck KGaA invested € 70 million (US$ 75 million) to triple its ADC manufacturing capacity at its Missouri (US) facility, aiming to support the rising demand for oncology therapies.Sterling Pharma entered into a partnership with GlycoNex to support the clinical trials of their ADCs that target solid tumors. And, NJ Bio and Charles River Laboratories also announced a collaboration to optimize ADC manufacturing.The adeno-associated viral (AAV) vector field also saw activity with Rentschler Biopharma and Forge Biologics announcing the launch of a new service offering and a manufacturing platform, respectively. Similarly, Andelyn Biosciences was selected by Hubble Therapeutics to manufacture clinical grade AAV.Meanwhile, Lonza has gone in for a restructuring exercise in order to become a “pure-play CDMO”. It has exited its capsules and health ingredients business, and adopted a new organizational structure. The Swiss CDMO has also extended a collaboration with a major global biopharmaceutical partner for commercial-scale manufacture of ADCs. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Our viewAs pharmaceutical development becomes increasingly complex, CDMOs are no longer just manufacturing partners, but critical innovation hubs. Little wonder then that 2024’s biggest pharma deal was in the CDMO space – Novo Holdings’ US$ 16.5 billion buyout of Catalent. This trend should gather momentum. We expect more M&A activity in this space in 2025.

Impressions: 3495

COMPANY BIO #AboutSupplier

Overview of Mikart's CDMO services, such as controlled substance formulations, oral solids & non-sterile liquid dosage forms on PharmaCompass.

Overview of Mikart's CDMO services, such as controlled substance formulations, oral solids & non-sterile liquid dosage forms on PharmaCompass. Q. What is a pharmaceutical CDMO? A pharmaceutical contract development and manufacturing organization (CDMO) is a company that provides drug development and manufacturing services on contractual basis. A contract development and manufacturing organization not only manages the outsourced production of drug substances and products, but also manages all of the research and development activities that occur before drug product manufacturing. The demand for contract development and manufacturing organizations has gone up due to the complexities and considerations brought on by the increasingly unique finished formulations in the market. Because of this reason, many pharmaceutical companies are outsourcing their drug product development and manufacturing requirements to CDMOs. The CDMO industry offers opportunities such as technological advancements, new operational techniques, higher company values and high profitability. Pharma companies hire CDMOs so that they can focus more on the primary attributes of their projects.The pharmaceutical contract development and manufacturing organization (CDMO) sector is promptly addressing the challenges within the industry. Pharmaceutical companies are increasingly relying on CDMOs to gain access to specialized expertise, control costs and considerably speed up the successful formulation development through clinical trials and commercial production.The CDMO industry offers opportunities such as technological advancements, new operational techniques, higher company values and high profitability. Pharma companies hire CDMOs so that they can focus more on the primary attributes of their projects. Q. What are the different services offered by pharmaceutical CDMOs? With the global pharma industry growing at a fast pace, big pharmaceutical companies are continuing to focus on their core business. With their promise of decreasing time to market and reducing costs, contract development and manufacturing organizations (CDMOs) have positioned themselves as alternatives to in-house development and manufacturing operations. The pharma companies are also seizing at this opportunity to outsource drug development to the CDMOs. The majority of formulations that pharma companies continue to outsource to CDMOs are solid dosage forms. Contract Development and Manufacturing Organizations (CDMOs) offer their clients comprehensive services from drug development to manufacturing. The CDMOs offer integral services that include projects from external third parties and make use of their knowledge, development and manufacturing capabilities.With preformulation, formulation development services, clinical trials and commercial manufacturing, CDMO such as Mikart can start with a concept or a ready-to-use formula. CDMO companies offer services such as formulation, analytical services, blending, coating, converting, packaging, serialization and shipment. Full-service pharmaceutical contract development and manufacturing organization (full-service CDMO) such as Mikart can manage every aspect of formulation development and manufacturing. CDMOs will have several opportunities to grow in the near future. Big pharmaceutical companies are embracing outsourcing services as a strategic method to speed up their drug development timelines. Q. What are the benefits that contract development and manufacturing organizations offer to pharmaceutical companies? Formulation development and manufacturing is a complex process, and partnering with the right pharmaceutical CDMO (contract development and manufacturing organization) will help pharma companies through all stages of drug development and formulation. Pharmaceutical companies are relying more and more on contract development and manufacturing organizations (CDMOs) for different complex and novel formulation development and manufacturing. Outsourcing has become a market trend across the pharmaceutical manufacturing landscape. By choosing the right CDMO partner, pharma companies can avert delays and pitfalls. Contract development and manufacturing organizations (CDMOs) provide several benefits to pharmaceutical companies, such as: Technical Expertise: Pharma CDMOs have the technical expertise and technological and operational know-how to meet the needs of formulation development projects. Finding a CDMO with the right experience in different formulation technologies can also help a company to develop and manufacture a number of drug products. Many CDMOs can even provide nanotechnology, which is needed to solve some difficult formulation challenges. Experience: Experience is the most important factor in determining whether a manufacturing partner is capable of delivering the quality and scale required to ensure the success of a project. Full-service CDMOs and CMOs have a remarkable depth of experience and specialization in drug product development and manufacturing. CDMOs assess a compound's physical and chemical properties, evaluate the drug and its intended target site and recognize the drug's uptake. Quality: Quality should always be the most important factor one should consider while selecting a pharmaceutical contract development and manufacturing organization. CDMO such as Mikart are relatively economical and provide better quality products in higher quantities, at a faster rate and at lower costs. The focus of a pharmaceutical CDMO is always on pricing and factors that contribute to high quality, such as drug product manufacturing capacity, experience, reputation, technical competency, etc. Manufacturing Facilities: Outsourcing services to a contract development and manufacturing organization gives companies access to a larger number of equipment and facilities. There are various pharmaceutical companies that rely on outsourced facilities. This has provided the CDMO market the chance to grow and pharma companies the opportunity to avoid expenses associated with purchasing specialized equipment. For instance, If you are looking for the production of complex injectables, you should choose a CDMO that has equipment scale and material handling expertise with the preferred product batch size. Facilities should be assessed for class 100 clean room suites, laminar flow hoods, biosafety cabinets, etc. In addition, the CDMO must follow current good manufacturing practices (cGMP), which is necessary for compliance with regulatory guidelines. Speed: CDMOs generally offer better quality products in higher quantities, faster and at lower costs. A CDMO's value proposition to customers includes speed as a major aspect, and the key to optimized scalability is to maintain the correct pace for the exact product and quantity. Scalability: CDMOs are well known for their ability to provide scale-up for pharmaceutical companies. Due to their ability to scale up production without adding expenses of labor, facility space, etc, CDMOs and CMOs help pharma companies in meeting production deadlines. Cost-Effectiveness: Pharmaceutical CDMOs not only help companies to meet deadlines and scale up faster, but they also reduce infrastructure costs by lowering or removing the need for additional production. To control expenses, CDMOs should be used to influence procedure methodical testing counting in-machine inspections, verifications and non-destructive testing. The knowledge of an experienced CMO / CDMO partner and their advanced technologies often helps pharma companies in controlling costs during early stage drug development, while working on a very aggressive but realistic timeline.Q. What are the different CDMO services offered by Mikart?Mikart's more than 45 years of experience in oral solid and non sterile oral liquid dosage forms as well as its specialization in pediatric, geriatric and controlled substances, make it an ideal contract development and manufacturing organization partner from formulation development through commercialization. Mikart is a contract development and manufacturing organization (CDMO) that offers a full range of services for drug development and commercialization. Mikart has a number of capabilities including pharmaceutical drug development, clinical trial supplies, regulatory services, solid and liquid oral dosage form manufacturing, packaging and analytical services. Since its formation over 45 years ago, Mikart has been delivering the highest quality products, exceeding the most demanding client standards, regardless of where you are in the process, from conceptualization to maximizing market adoption. The Mikart experience is distinguished by transparency, reliability and responsiveness, which serve as the foundation for expert, flexible solutions to advance your products. From formulation through full-scale commercialization, Mikart has proven expertise in oral solids (tablets and capsules) and non-sterile oral liquid dosage forms with a focus in pediatrics, geriatrics and controlled substances. Mikart delivers the high-quality services that you require, along with the speed and responsiveness that you want. As a contract development and manufacturing organization (CDMO), it offers a comprehensive suite of integrated services and technologies, and supports the development, manufacturing and packaging of oral solids and non-sterile liquid dosage forms. The various services offered by Mikart are as follows: - Analytical method development - Preformulation - Formulation development [Fast dissolve (ODT), modified release, multiple-unit pellet system, oral solutions, oral suspensions, powder for oral solutions and film-coated tablets] - Scale-up - Site and technology transfer - Packaging- Regulatory support Mikart provides pharmaceutical manufacturing services for clinical trial materials, physician samples and commercial products.

Impressions: 1675

NEWS #PharmaBuzz