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

Mission Pharmacal enters into agreement with MainPointe Pharmaceuticals

21 Feb 2018

// PRESS RELEASE

Mission Pharmacal General Counsel gains national recognition for ethics

24 Oct 2017

// PRESS RELEASE

Fewer than half of U.S. women take recommended vitamins prior to pregnancy, according to March of Dimes new Prenatal Health & Nutrition Survey

19 Sep 2017

// PRNEWSWIRE

DATA COMPILATION
#PharmaFlow

Contact Supplier

Website

RDD 2025

Not Confirmed

Book a meeting

envelop Contact Supplier

DIGITAL CONTENT

2 Corporate Content #SupplierSpotlight, 1 Company Bio #AboutSupplier, 1 Data Compilation #PharmaFlow, 29 News #PharmaBuzz

media
2 Corporate Content #SupplierSpotlight
1 Company Bio #AboutSupplier
1 Data Compilation #PharmaFlow
29 News #PharmaBuzz

FINISHED DOSAGE FORMULATIONS

27 FDF Dossiers, 25 FDA Orange Book, 2 Canada

27 FDF Dossiers
25 FDA Orange Book
2 Canada

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
- 9 Formulation Development
Packaging
- 8 Contract Services

KEY SERVICES

Topical Formulation Development Services, Controlled & Immediate Release Tablets, CDMO for Topical & Oral Liquids, CDMO for Semi-solids

Topical Formulation Development Services
Controlled & Immediate Release Tablets
CDMO for Topical & Oral Liquids
CDMO for Semi-solids

INSPECTIONS & REGISTRATIONS

14 FDA, 1 EDQM, 1 GDUFA

inspections
14 FDA
1 EDQM
1 GDUFA

Mission CDMO team brings reliability, resourcefulness, & responsiveness in executing your development project.

About

Mission CDMO offers a full range of contract services in our FDA-registered, cGMP compliant facility located on our expansive Boerne, Texas campus. Our experienced team is dedicated to providing customized solutions to meet your product and partnership needs. Let us take your product from concept to commercialization as we create a partnership that executes your vision and exceeds your expectations. Mission CDMO manufactures high-quality prescription drug products, over-the-counter drug products, and dietary supplements for our company and for our customers in our FDA-registered, cGMP compliant facility.

CPhI North America CPhI North America

Industry Trade Show

Not Confirmed

20-22 May, 2025

Pennsylvania Conv Center, Philadelphia
RDD 2025RDD 2025

Industry Trade Show

Not Confirmed

06-09 May, 2025

Estoril (Lisbon) Portugal
Bio KoreaBio Korea

Industry Trade Show

Not Confirmed

07-09 May, 2025

Coex, Seoul

CONTACT DETAILS

Click the arrow to open the dropdown

Country

U.S.A

Address

38505 IH 10 West, Boerne, TX 78006

Telephone

+1 8302499822

CDMOSolutions@missionpharmacal.com

Website

https://missioncdmo.com/

YouTube

Digital content

Explore the latest content creation from this company

CORPORATE CONTENT #SupplierSpotlight

Corporate Presentation

GMP Certificate 2013

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: 3039

COMPANY BIO #AboutSupplier

View Mission CDMO's services for oral and topical drug delivery & browse its CDMO capabilities for tablets, liquids, creams & gels on PharmaCompass.

View Mission CDMO's services for oral and topical drug delivery & browse its CDMO capabilities for tablets, liquids, creams & gels on PharmaCompass. What is Mission CDMO, and what CDMO services does it provide? Mission CDMO is a leading contract development and manufacturing organization (CDMO) that offers a comprehensive range of contract services within its FDA-registered, cGMP-compliant facility located on its expansive campus in Boerne, Texas. With a commitment to delivering customized solutions, Mission CDMO transforms products from concept to commercialization, building strong partnerships to execute client visions and exceed expectations. Mission CDMO specializes in contract formulation development and manufacturing services across a variety of dosage forms, including liquids, semi-solids, and oral solid dosage forms such as tablets including controlled release tablets. Mission CDMO provides contract manufacturing for various topical formulations (topical products), such as solutions, creams, ointments, gels, and lotions. Their formulation techniques ensure stability, targeted delivery, and regulatory compliance, making them a trusted partner in topical formulations. In addition to topical products, Mission CDMO excels as a contract development and manufacturing organization (CDMO) for oral dosage forms, including oral solids and oral liquids. For oral liquids, they focus on achieving optimal solubility, stability, and bioavailability, ensuring product efficacy. For oral solid dosage forms such as tablets including controlled release tablets, Mission CDMO utilizes advanced technologies such as high-shear granulation, fluid bed granulation, and direct compression to create high-quality oral drug products. Mission’s capabilities extend to immediate-release and extended-release tablets, employing rigorous testing methods to ensure potency, uniformity, and stability.Mission CDMO’s expertise spans contract manufacturing for topical formulations and oral dosage forms, supported by cutting-edge formulation development services. Their dedication to quality, innovation, and regulatory compliance positions them as a trusted partner for bringing diverse products to market.What approach does Mission CDMO’s team of formulation experts take to develop customized topical and liquid dosage forms? Mission CDMO is a leading provider of topical formulation development services and liquid formulation development services, offering customized solutions for topical drug delivery and oral liquid dosage formulation development.In topical formulation development, Mission CDMO specializes in semi-solid topical drug products such as creams, ointments, gels, and lotions. Their approach integrates advanced techniques and a deep understanding of ingredient properties to optimize stability, user experience, and therapeutic efficacy. By focusing on patient compliance, quality control, and targeted delivery, Mission’s team ensures high-performing topical drug products that meet diverse therapeutic requirements.Mission CDMO also excels as a CDMO for oral liquids, offering comprehensive liquid contract manufacturing services. Their liquid formulations include solutions and suspensions designed for systemic delivery, particularly beneficial for patients who struggle with swallowing solid dosage forms. Mission CDMO’s liquid formulation development services enhance the bioavailability of active pharmaceutical ingredients (APIs), ensuring efficient absorption and therapeutic effectiveness.Additionally, Mission CDMO employs advanced formulation techniques for liquid drug product manufacturing, such as taste-masking strategies through flavor enhancers or encapsulation, to improve the palatability of oral liquid formulations.Mission CDMO’s expertise spans both topical drug delivery and liquid formulations, ensuring compliance with therapeutic needs and regulatory standards. Through their expertise in topical formulation development services, liquid formulation development, and liquid drug product manufacturing, Mission CDMO delivers innovative and tailored solutions that elevate the quality and performance of topical and oral liquid dosage forms. Their commitment to excellence establishes them as a trusted partner in topical drug delivery and oral liquid contract manufacturing services. What strategy does Mission CDMO use to deliver integrated packaging and analytical support services? Mission CDMO, a leading contract development and manufacturing organization (CDMO), provides a wide array of contract packaging services to support the final stages of drug product manufacturing of oral and topical dosage forms.These packaging services encompass both primary packaging and secondary packaging, tailored to meet specific client requirements and regulatory standards. By offering custom packaging solutions, Mission CDMO ensures that solid, liquid and semi-solid topical products are efficiently packaged, labeled, and sealed to maintain their integrity and quality.Primary packaging solutions, such as blister packaging, are designed to protect the drug product while enhancing usability for consumers. Secondary packaging services further complement this by providing additional layers of protection and branding opportunities, ensuring finished drug products are ready for distribution and market presentation. Mission CDMO’s expertise in custom packaging allows them to address unique client needs, aligning with therapeutic goals and market demands.Beyond packaging services, Mission CDMO integrates analytical solutions to ensure the highest standards of quality and compliance. Their team conducts rigorous testing, including stability testing, potency assays, and purity analysis, to validate product safety and efficacy. Through robust quality control processes, they maintain product integrity throughout the packaging and manufacturing phases.By combining advanced contract packaging services with analytical rigor, Mission CDMO offers end-to-end solutions that streamline the development and commercialization process. Their dedication to primary and secondary packaging, custom packaging, and regulatory compliance establishes them as a trusted partner in packaging services for a wide range of products.What measures does Mission CDMO take to ensure quality and consistency across various dosage forms? Mission CDMO, a leading contract development and manufacturing organization (CDMO), ensures quality, regulatory compliance, and consistency across diverse dosage forms, including topical liquids, topical semi-solids, oral liquids, and oral solid dosage forms such as tablets. Their approach combines regulatory support, stringent quality control, and advanced formulation techniques to address client and market needs.Mission CDMO provides expert assistance in preparing and submitting regulatory documents to global agencies like the FDA, EMA, and other regulatory bodies. They help clients navigate regulatory hurdles and ensure compliance with guidelines. This support of Mission CDMO includes advising on regulatory strategies, product approvals, and maintaining compliance throughout the development and manufacturing process.Their rigorous quality control process involves extensive testing for potency, uniformity, stability, and safety across all dosage forms. This meticulous process ensures efficacy and reliability while maintaining strict adherence to the guidelines set by health authorities.For topical liquids and topical semi-solids such as creams, ointments, gels, and solutions, Mission CDMO’s tailored formulations optimize therapeutic delivery, stability, and patient compliance. For oral liquids and oral solids, their advanced formulation techniques enhance bioavailability, palatability, and stability, ensuring efficient absorption and therapeutic effectiveness.By integrating regulatory support with advanced quality control processes, Mission CDMO delivers consistent and compliant solutions across topical liquids, oral liquids, topical semi-solids, and oral solid dosage forms, establishing themselves as a trusted partner in the pharmaceutical and manufacturing industry.

Impressions: 143

NEWS #PharmaBuzz