F4CL - "Fast for Commercial Launch" Platform
Product Description
WuXi STA
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US -
2015On CPHI since
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3Certificates
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5000+Employees
Company types
Categories
WuXi STA
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US
-
2015On CPHI since
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3Certificates
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5000+Employees
Company types
More Products from WuXi STA (13)
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Product in-vivo PK Studies
Our drug product pre-formulation and formulation development services can also includes in vivo PK studies, conducted with multiple animal species and a rapid turnaround time. This additional service further extends our full suite offering to our clients while eliminating the need for additional vendor sou... -
Product Injectable Formulation Development & Fill-Finish Services
WuXi STA offers a wide range of tailored services and solutions for clients developing injectable formulations. Form types include solution, emulsion, sterile powder (lyophilized) and liposome. Our offering includes formulation development, performance analysis and characterization testing, and fill/... -
Product Global Regulatory Affairs & CMC Submission Support
WuXi STA's dedicated Global Regulatory Affairs CMC teams offers comprehensive CMC documentation support for IND, CTA, MAA, and NDA applications in western countries and China. Our highly experienced team works with your NCE programs to prepare Module 2 and Module 3 of your regulatory dossier through foreca... -
Product Packaging & Labeling Solutions
At WuXi STA, we understand the need for flexibility at the early stages of clinical testing and how aspects such as effective dose, stability and compliance requirements can change your needs abruptly. Our packaging team will work with you to collect the relevant data and test various packaging options as ... -
Product Oral Dose Drug Product Development & Manufacturing
WuXI STA's comprehensive drug product development platform for oral dosage forms offers our clients a complete line of solutions from pre-formulation development through to final product manufacture at commercial scale. Our capabilities include;
• Solid oral tablet/capsule (including liquid... -
Product F2CS - "Fast to Clinical Supply" Platform
Your innovative therapy is ready to reach a key milestone with the IND date quickly approaching. You need a reliable partner to formulate and manufacture your therapy to meet the IND filing requirements and the dose needs for phase I studies fast.
Every innovation is unique so your partner needs... -
Product IND Enabling Preformulation Package (IEPP)
WuXi STA's IND Enabling Pre-formulation Package (IEPP) is an integrated and end-to-end developability assessment service for new chemical entities (NCE's). Through this comprehensive service, you can efficiently identify challenges and tailored solutions earlier for higher project success rates and lower o... -
Product Small Molecule API Development & Manufacturing
WuXI's unrivaled API development platform provides our client with a robust platform to bring their drug to market. With a proven track record of success and trust in bringing life changing therapeutics to market, we are a go-to partner for clients looking for tailored and customized drug development and m... -
Product Bioavailability Enhancement & Advanced Delivery Technologies
Our bioavailability toolbox offers a customizable solution to your drug delivery challenges.
- Spray-Dried Dispersion (SDD)
- Hot Melt Extrusion (HME)
- Nano-suspensions & Lipid Nanoparticles
- Softgel & Liquid Filled Capsules
- Injectable Formulations\
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Product Peptide CRDMO Platform
WuXi TIDES's Peptide platform includes a complete offering of services to bring your protein therapeutic to market faster while supporting a wide variety of conjugates including PPMO, Peptide-Antibody, Peptide-Linkers.
Services include but are not limited to: - Comprehensive Discovery Service... -
Product Oligonucleotide CRDMO Platform
WuXi TIDES has a robust and integrated Oligo API Platform, offering R&D and manufacturing services from preclinical to commercial scale and operating out of our US FDA inspected facility based in Changzhou, China. We support the development and manufacture of a variety of oligonucleotide modalities inc... -
Product Highly Potent API (HPAPI), ADC Payload, and Payload-Linker Manufacturing
Our Jinshan and Changzhou sites are equipped with multiple R&D labs as well as a dedicated cGMP HP Kilo lab and plant for producing and manufacturing highly potent APIs (HPAPI's), antibody drug conjugates (ADC's), payloads, and payload-linkers. We currently offer drug product manufacturing at STA’...
WuXi STA resources (16)
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News New drug product service delivers expedited CTM
Biotech and pharma innovators are facing considerable challenges to find CDMO partners with capacity and capability to quickly develop and deliver high-quality CTM with flexible options+ -
Sponsored Content End game strategies to reach patients globally and swiftly
The journey for new therapies is long; wondering if a proven therapy will be produced and distributed efficiently to reach the intended markets as soon as possible should not be another burden -
Video Case Study - Integrated CMC to IND in 10 Months
A Case Study of WuXi Speed and Service for a client. The project, which encompassed an integrated CMC approach to bring a molecule to IND phase was completed in 10 months -
News Hoth Therapeutics and WuXi strike API and drug product deal for cancer therapeutic
WuXi will use its new modality platform to provide an end-to-end solution for oligonucleotide peptide -
Video WuXi STA IND Enabling Preformulation Package
WuXi STA's IND Enabling Preformulation Package (IEPP) is an integrated developability assessment service for new chemical entities (NCEs) to efficiently identify challenges and solutions earlier for higher success rates and lower overall costs. This video explains the package and process. -
News WuXi STA completes acquisition of its first European facility
The purchase of BMS's Couvet, Switzerland facility adds commercial-scale production capacity for capsule and tablet dosage forms -
Brochure F2CS: Fast to Clinical Supply
F2CS - fast to clinical supply service package delivers reliable clinical trial materials (CTM) fast with flexible options custom developed by highly experienced integrated teams equipped with advanced technologies, working in parallel to save time. -
News 2021, WuXi STA Again Wins CMO Leadership Awards in All Six Core Categories
WuXi STA has been deeply involved in the CDMO industry for more than ten years. In the year of 2020 alone, WuXi STA served more than 470 customers worldwide, supporting 13 NDA approvals globally including 5 from US FDA, 4 from EU EMA, 2 from China NMPA and 2 from Japan PMDA. Dr. Minzhang Chen, CEO of WuXi STA, commented: “Thanks to our partners for their recognition of WuXi STA, and we will continue to leverage our end-to-end CMC platform, along with the global standard quality systems to empower more partners to accelerate their pathway to market for the benefit of global patients.” -
Whitepaper IND Enabling Pre-formulation Package (IEPP)
WuXi STA's pre-formulation package IEPP (IND Enabling Pre-formulation Package) helps you select the best drug candidates at late discovery phase and develop the most suitable formulation for phase I in 8-12 weeks,
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News Three WuXi STA Facilities Pass Pre-Approval Inspection From NMPA
STA Pharmaceutical, a WuXi AppTec company (WuXi STA), a leading contract development and manufacturing organization (CDMO) announces that three of its sites in China have successfully passed pre-approval inspections (PAI) by the China National Medical Products Administration (NMPA) concurrently for an innovative drug from its partner. -
News Three WuXi STA facilities pass pre-approval inspection from NMPA
The achievement validates the company's CMC capabilities and quality -
News WuXi STA Opens Oligonucleotide Large-Scale Manufacturing Facility
STA Pharmaceutical Co., Ltd., (WuXi STA) – a subsidiary of WuXi AppTec – today announced the opening of its large-scale oligonucleotide oligonucleotide active pharmaceutical ingredient (API) manufacturing facility in Changzhou, China. This significant milestone marks WuXi STA's establishment of a comprehensive one-stop platform to support the process R&D and manufacture of oligonucleotide APIs from preclinical to commercial. It enables customers around. -
News WuXi STA to Purchase Bristol Myers Squibb Manufacturing Facility in Couvet, Switzerland
Bristol Myers Squibb (NYSE: BMY) and WuXi STA – a subsidiary of WuXi AppTec – today announced that WuXi STA has agreed to purchase Bristol Myers Squibb’s manufacturing facility in Couvet, Switzerland. The Couvet site will be the first facility in Europe for WuXi STA, a leading Contract Development and Manufacturing Organization. The acquisition will enhance WuXi STA’s existing capabilities while growing capacity to support its partners’ life-saving work. -
News WuXi STA to grab foothold in Europe with planned BMS facility purchase
The acquisition will expand the CDMO's capabilities and capacity to serve European markets -
News WuXi Biologics, WuXi STA and Antengene collaborate to advance ADC candidate
The Wuxi companies will provide process development, scale-up, and GMP to advance Antengene's ADC program to clinical stage
Frequently Viewed Together
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Product Functional film coating
Easy, fast and reliable enteric protection? Why not! - High performance protection against acidic conditions. - Suitable for granules, pellets, tablets and capsules. - For pharmaceutical and nutraceutical applications.
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Product ADAPTEK® TECHNOLOGY
ADAPTEK® TECHNOLOGY is the general name for our 4 international patents and expertise in nanotechnology and controlled release systems.This is a transversal technology that allows to develop customized biopolymeric nanohydrogels, allowing the load with different API (drugs, vitamins, growth factors, etc.)....
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Product Oradel
The proprietary Oradel platform is a line of oral delivery coating techniques that can be used individually or together to meet any custom delivery requirements. Our Wurster coating capabilities allow us to add numerous coating layers to a core. These layers could be a simple coating formulation or could c...
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Product VetaFilmTM - Veterinary Oral Film Technology
VetaFilm™ is our proprietary veterinary oral film technology that provides significant market opportunities to improve drug delivery for companion animals. VetaFilm™ research and development services and veterinary oral films provide: • Dose placed directly on oral mucosa or on their f...
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Product VELOXTAR™ technology
VELOXTAR™ is a technology that produces a very thin orally disintegrating tablet (ODT) like a coin. The distinctive tablet shape and unique formulation design allow the ODTs to disintegrate in 4-6 seconds. VELOXTAR™ technology significantly reduces the disintegration time, while still providing practical t...
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Product Continuous Manufacturing of Formulations in Minutes Instead of Hours
Microinnova Engineering GmbH has successfully commissioned two continuous formulation production plants for a European client. The design of the fully automated plant is very compact, which makes it possible to easily transport & install it at a different manufacturing site on the other side of the wor...
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Product Spray Drying
We have been successfully developing spray dried formulations for our customers for more than twenty years. Our experience spans a vast range of therapeutics from small molecule API’s to even the most sensitive and complex biologicals.
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Product Quality - QEdge - Enterprise Quality Management Suite
Sarjen Systems’ QEdge is an enterprise-wide Quality Management System (QMS) specifically designed for pharmaceutical manufacturing. This risk-based QMS offers a comprehensive suite of solutions, including:
• Process Control • Document Control & Issuance • Training Management System • Ve...
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Product Lozenges
Our range of user-friendly dosage forms includes lozenges. Lozenges are an easy way to take medication and, with a wide range of flavorings available, there is something for everyone. Designed to dissolve or disintegrate slowly in the mouth, lozenges are capable of providing both a localized effect and a...
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Product Contract Development Services
Famar R&D is offering a complete set of Contract Development services.
• Formulation and process development for Rx, Gx, OTC, Cosmetics (Solids, Semi-solids /liquids dosage forms, Sterile liquids & Lyophilized powders) and Medical Devices • Analytical methods development and validation&nbs...
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Product Succinyl Gelatin Injection
Succinyl Gelatin Injection is a plasma volume substitute. This means, it replaces fluid lost from the circulation. It is used to replace blood and body fluid, which have been lost as a result of, for example, an operation, an accident or a burn. It can be used instead of, or as well as, a blood transfusion...
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Product CDMO Best Practices from Benches to Batches - How to Transition from Cli...
What you need to seamlessly transition from clinical phases to commercial readiness.
Three unique abilities your CDMO must have to complete your project within your timeline are capability, flexibility and availability.
August Bioservices' Director of Customer Operations, Commercial Devel...
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Product Development Services
Comprehensive R&D Services • Preformulation • Formulation Development of Solid Dose Tablets (Capsules, Liquids & Solutions) • Pediatric Formulation • Product Design • Formulation Optimization • Sourcing of APIs & Excipients • Analytical Method Development & Validation • ...
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Product Pharmaceutical Deformulation / Reverse Engineering
Our experience in excipient characterization and deformulation of pharmaceutical formulations gives us the opportunity not only to identify and quantify individual excipients in a complex pharmaceutical formulation, but often also confirm the excipient grade, excipient quality and sometimes even the excipi...
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Product Pharmacokinetic modeling
The SurroGUT™ platform is a powerful tool for developing advanced predictive Physiologically Based Biopharmaceutics (PBB) models and mechanistic in vitro–in vivo correlations (IVIVCs). It uniquely combines TIM dissolution experiments, TIM gastrointestinal fluids, cell-based microfluidics, and GastroPlus® s...
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Product Pre-Formulation Services
A wide range of IND enabling drug product services are provided at Eurofins CDMO. Our PhD scientists have extensive experience in material characterization, analytical chemistry and strategies for developing poorly soluble compounds. Our Pre-Formulation laboratory is fitted with a suite of specialized equi...
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Product Sterile monodose cosmetics
At Neftis Laboratorios, we manufacture cosmetic products for third parties, including mesotherapy products. This beauty technique is one of the most widely used treatments for rejuvenating the face, fighting cellulite and eliminating localised fat. We have the latest technology at your disposal to create i...
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Product Complex Semi-synthetic APIs
Micafungin Sodium, Anidulafungin-Fructose, Dalbavancin, Everolimus, Sarecycline, Midostaurin etc.
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Product Formulation Development
Recipharm offer formulation development services for all dosage forms. We develop everything from simple formulations for early studies to more complex formulations suited for commercialisation.
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Product UniLayer - 200mg Ibuprofen
This product is suitable for children as a delivery system.
Must be taken with water or beverage of choice.
We are looking for partner on a CDMO bases.
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Product Formulation Development
MedPharm has more than 20 years’ experience developing topical and transdermal formulations. We can begin as early as API screening and support pre-formulation activities, lead formulation selection, formulation optimization and reverse engineering. We have had a role in taking over 55 products to mark...
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Product Geoclock® Technology_Customisable chronotherapy
Geoclock® allows for timed release of drugs that is independent of food or pH. Geoclock® is a validated oral drug delivery technology that can be used to release the drug from the tablet after a pre-determined lag-time that is independent of food or pH. Geoclock® can additionally be used for multi...
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Product DEVELOPMENT AND EFFICACY EVALUATION OF PHARMACEUTICAL OTC PRODUCTS AGAIN...
DEVELOPMENT AND EFFICACY EVALUATION OF PHARMACEUTICAL OTC PRODUCTS AGAINST BLOOD-SUCKING ARTHROPODS.TECNALIA offers standardized (WHO, EPA) and internal protocols regarding efficacy evaluation reports for product development and registration. Pediculicides against head lice crawling stages and eggs. ...
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Product OTF - Oral Thin Films
Oral thin films are loaded with active substances. The Thin films are taken orally and dissolve immediately in the mouth or are applied to the mucosa. For transmucosal films, the active substance enters the bloodstream directly via the oral mucosa, without having to first pass through the gastrointestinal ...
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Product CordenPharma ONE PARTNER CDMO Video
Your ONE PARTNER CDMO for Fully-Integrated Supply
As your ONE PARTNER CDMO, CordenPharma provides contract manufacturing of APIs, Excipients, Drug Products & Packaging in an integrated solution spanning all product life cycle stages, from preclinical to commercial, supported by dedicated regulator...
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Product Products for pets
Products for pets : tablets, powders, oral gels and pastes ... filled in specific packaging according to species, product, dosage, use : syringe, airless pump bottle, plastic tube, plastic bottle // Using animal orgin factors to enhance palability // Compliant to EU regulation
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Product UV Light Blocking Tyvek Equipment Covers
UV Light Blocking Tyvek Equipment Covers are designed to keep cleaned pharmaceutical equipment and supplies clean and protected from external sources of contamination while also providing in-process protection to light sensitive biotech products.
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Product Food Supplement range of products
We offer a wide range of food supplements ready to be put on the market. Available formulations in Basic Health - Energy - Osteo and Joint Care - Immuno and Womens' Health.
We can also realize your idea of product and offer a full customised development.
Contact us for more info
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Product Development Oral Solid Dosage forms
XEDEV provides wide range of technologies going from powder to tablet in order to develop your final oral solid dosage form. • spray-drying • encapsulation • granulation (wet, dry and hot) (batch and continuous) • tableting • coating Contact us for more information.
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Product Hot Melt Extrusion
To successfully develop and manufacture your polymer-based delivery systems, like implants and intra-vaginal rings, we have advanced extrusion capabilities in Malmö (Sweden) and Putnam (US Connecticut). The US site is also a center of expertise for Hot Melt Extrusion (HME).
HME improves the bioa...
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Product Translational Pharmaceutics
Translational Pharmaceutics®, accelerates development by integrating formulation development, real-time manufacturing and clinical testing. This integrated approach is proven to reduce timelines by more than 12 months and lower R&D costs by more than $100 million. Over the past decade ...
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Product Isotretinoin soft caps
GAP is offering for out licence ISOTRETINOIN soft caps 5-10-20-40mg with the most updated BE study (2018)
GAP manufacturers per year over 250 milion caps of Isotretinoin Product is offered for licensing or contract manufacture agreement
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Product F2CS - "Fast to Clinical Supply" Platform
Your innovative therapy is ready to reach a key milestone with the IND date quickly approaching. You need a reliable partner to formulate and manufacture your therapy to meet the IND filing requirements and the dose needs for phase I studies fast.
Every innovation is unique so your partner needs...
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Product Huons Dental Cartridges
Lidocaine HCl 2% + Epinephrine 1:100,000 Inj. Lidocaine HCl 2% + Epinephrine 1:80,000 Inj. Articaine HCl 4% + Epinephrine 1:100,000 Inj.
Cartridge Ampoule packed Dental Anesthetics
Currently exporting to more than 30 countries in the world.
Looking for a capable importer/dist...
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Product Betahistine 12.5 mg/ml Oral Drops
Glass bottle containing 100 ml oral solution with disposal pump.-comp245299.svg)
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Product Clinical Manufacturing
.Integrated drug development service (CRO/CDMO) including clinical manufacturing and management.
The range of activities offered by Bluepharma includes:
- Clinical material cGMP manufacturing
- Clinical supply management
- clinical material
- placebo
- ...
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Product Formulation Development including Inhaled Products
Inhaled products and formulation development: The development of drugs using experimental design approaches with integrated stability testing and storage is available from us. Our formulation specialists can provide a wide range of formulations in a timely and cost-effective manner in order to identify t...
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Product Metformin+Sitagliptine 500mg/50mg Tablet
Nanjing sino pharmaceutical ltd. Provides wide range of products which includes Metformin+Sitagliptine 500mg/50mg Tablet. Indication: Metformin and sitagliptin are oral diabetes medicines that help control blood sugar levels.Contact us for more information.
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Product Contract Manufacturing Services
To learn more about our Contract Manufacturing Services in Malta, please contact: nfessa@pharosgr.gr
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Product Paracetamol (Acetaminophen) Tablet/Caplet
Annual Output Capacity:8,000,000,000 tabletsContract Manufacture
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Product Formulation Development
The NUVISAN formulation group up has a proven heritage of effective product development with team members being responsible for the creation of topical formulas that supported several commercially successful products. These successes were underpinned by our focus on innovation and patient and health care p...
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Product Manufacturing Solutions
We are GMP-certified for the manufacturing of IMP clinical batches (Phases I-III) as well as commercialized products. Our laboratories are prepared to work with over 30 key pharmaceutical technologies, all API types from OEB classes 1-5 and narcotics, innovative technologies, hard-to-make formulations in a...
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Product Oral Solid Dosage Form Contract Manufacturing
Pfizer CentreOne excels in the manufacture of oral solid dosage forms.
From hormones to immunosuppressants to sensitizers, we're known for our:
• Specialized technologies • Containment expertise • Deep technical and commercial know-how You can count on our devotion to you and your drug, ...
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Product Pediatric Development
Pediatric formulation and product development
The development of acceptable, palatable pediatric formulations is a key feature within the industry today, driven by patient needs and regulatory requirements. Quotient Sciences has extensive knowledge and capabilities that enable us to provide you...
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Product CONTRACT MANUFACTURING - SMALL MOLECULES
KD Pharma’s professional expertise, state-of-the-art assets and proven track record in regulatory compliance allow us to become your preferred CDMO solutions partner.
Your Agile Experts
• Responsive to our customers’ needs in a more dynamic customer-centric way • Adaptive to the most diverse re...
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Product Finished dosage forms
TABLETS /FILM-COATED TABLETS
• Batch size 100 – 600 kg
• OEB classes: 1 – 3
• Aqueous film coating
SUPPOSITORIES
•Batch size 100 – 450 kg
•Automatic filling into PVC / PE, PVC / PVDC / PE or aluminium foil
•Capacity of approx. 20,000 suppositories per hour
• Inli...
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