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Mikart Celebrates 50 Y of Excellence in Pharma Manufacturing

16 Jan 2025

// PRESS RELEASE

Mikart Celebrates 50 Years In Pharma Manufacturing Excellence

16 Jan 2025

// PR NEWSWIRE

Mikart Adds Nitrogen-Purged Capability to Liquid and Suspension Suites

24 Oct 2024

// PRESS RELEASE

DATA COMPILATION
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DIGITAL CONTENT

9 CORPORATE CONTENT #SupplierSpotlight, 1 COMPANY BIO #AboutSupplier, 1 DATA COMPILATION #PharmaFlow, 20 NEWS #PharmaBuzz

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9 CORPORATE CONTENT #SupplierSpotlight
1 COMPANY BIO #AboutSupplier
1 DATA COMPILATION #PharmaFlow
20 NEWS #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

1 VMF

1 VMF

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

Controlled Substance Formulation Development, CDMO for Tablets

Controlled Substance Formulation Development
CDMO for 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.

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17-20 March, 2025

New York, USA
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01-03 April, 2025

Javits Center, NYC
AAPS National BiotechAAPS National Biotech

Industry Trade Show

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04-07 May, 2025

Boston, MA

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U.S.A

Address

1750 Chattahoochee Ave. Atlanta, GA 30318

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+1 8884645278

bizdev@mikart.com

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https://www.mikart.com/

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CORPORATE CONTENT #SupplierSpotlight

Corporate Presentation

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DEA Benefit of Partnering with Mikart CDMO

Serialization

Packaging Solutions

Manufacturing Services

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Clinical Trial Labeling, Packaging & Manufacturing

Analytical Services

TrackWise Digital eEQMS

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Corporate Video

DATA COMPILATION #PharmaFlow

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: 2399

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: 1469

NEWS #PharmaBuzz