Regulatory Status

Regulatory Status
Product Description

Main Authorizations for Markets


China CN FDA and Brasil ANVISA in process

CIT S.r.l.

  • IT
  • 2020
    On CPHI since
  • 4
    Certificates
  • 25 - 49
    Employees
Company types
Contract Service
Specifications

CIT S.r.l.

  • IT
  • 2020
    On CPHI since
  • 4
    Certificates
  • 25 - 49
    Employees
Company types
Contract Service

More Products from CIT S.r.l. (2)

CIT S.r.l. resources (2)

Recommended Products

  • Product Analytical Services

    With 55+ years of experience, our expert teams develop 1,000+ analytical methods and validate 250+ methods annually. Drawing upon an extensive range of analytical technology, combined with a wealth of analytical knowledge, we can add real value to your drug development and commercialisation programs....
  • Product Biosimilars Portfolio

    • Pegfilgrastim (Filed with EMA) • Filgrastim (Filed with EMA) • Trastuzumab (Filed with EMA, MHRA, Received recommendation for marketing authorization in India) • Bevacizumab (Filed with MHRA) • Omalizumab (Global PhIII ongoing) • Denosumab (Global PhIII ongoing) • Ranibizumab (Global PhIII ongoing...
  • Product Consulting Services

    Providing specialist knowledge, expert advice. We are your point of call if you want to be proactive and drive improvements, or if you have some specific regulatory or technical issues and need guidance. We offer the following services: - Development and implementation of cost-effective, co...
  • Product HCG/Chorionic Gonadotrophin for Injection -OVIGIL HP 5,000 IU

    The Gonadotropin That Delivers – Precision, Reliability & Consistency

    This product is available as a combi pack of Chorionic Gonadotrophin for Injection BP 5000 IU & Sodium Chloride Injection BP 0.9% w/v (HCG Injection).
    • Use: This highly purified Human Chorionic Gonadotropin...
  • Product Liquid Solutions

    Chemical solutions (GMP-compliant): • API & excipients • Hazardous materials • Explosives • Filling under inert gas
    Special extracts and tinctures: • Mother tinctures • Boswellia extract • Opium tincture • Capsicum extract • Henbane extract • Cannabis extract
    Packaging  • 2...
  • Product Custom Protein Synthesis

    We provide a Custom Protein Synthesis Service, using a chemical method that synthesises proteins amino acid by amino acid and making modifications on an atomic-scale. We work closely with our partners in designing, customising and optimising the proteins that is synthesized in an automa...
  • Product Analytical Services

    Actylis performs routine and non-routine analytical testing for various industries, in support of manufacturing processes, QA/QC functions, R&D projects, and environmental applications. Leveraging state-of-the-art instrumentation, extensive knowledge base, as well as internal, cross-functional competen...
  • Product Fexofenadine Hydrochloride Tablets - Fexoquit


    Fexoquit contains Fexofenadine which is selective, non-sedative H1 receptor antagonist. It offers distinct advantage over other antihistaminic by not interacting with muscarinic receptor.

    Indication - It is indicated in Runny nose, itching, Sneezing, Watery eyes, rhinorrhea, Lacrim...
  • Product EUDRAGIT® Functional Polymers

    Evonik is a global development partner and solutions provider for oral drug delivery. For more than 60 years, we have been providing renowned pharmaceutical and biotech companies with oral drug delivery solutions to help them enhance drug performance, reduce project complexity, increase speed to market and...
  • Product Certified toxicological studies

    Toxicological tests performed at the Lukasiewicz - IPO:
    -allow a toxicological evaluation of chemical substances contained in pharmaceutical products, veterinary medicinal products, plant protection products, food and feed additives, industrial chemical substances, etc.,

    -make it possi...
  • Product Intelligent Integrated Solution for cell-derived products purification

    细胞源性产品智能纯化工艺系统是金赛尔再生医学有限公司设计的一款封闭式自动化切向流净化设备。其 CPCV (Constant Pressure Constant Volume) 切向流过滤控制系统实现了细胞衍生产品(如细胞外囊泡重组蛋白载药脂质体等)的全自动浓缩洗涤和包装,同时最大限度地保留了产品活性。

  • Product GMP API Manufacturing

    Process development and manufacturing services represent a core part of our business. We utilise accumulated know-how and advanced technologies and provide everything that you desire from a high-quality API supplier. ChemCon is also experienced in manufacturing regulated substances and has the flexibility ...
  • Product Health Economics & Value

    Even if your objective seems clear–demonstrate the value of your product – it is rarely a simple task. That is because there is no single story or piece of evidence when you speak to audiences around the world: regulators, health technology assessment (HTA) bodies, payers, providers and patients. IQVIA ...
  • Product Vinpocetine-aconitum 5, 10 Mg Hard Capsules or Tablets

    Vinpocetine is a time - tested remedy for the treatments of cerebral blood flow. Vinpocetine reduces the brain cell sensitivity to the lack of oxygen and protects them from damage, does not increasing the total blood pressure. It has been observed that vinpocetine has a positive effect on cognitive functio...
  • Product Dosecare

    Dosecare is a dosing syringe for oral liquids.

    It differs from the others as it allows you to simply and intuitively save the dose of liquid to be administered. Therefore once the dose is set, dosing errors are prevented, time is saved, there is no waste and soiling.

    Thos...
  • Product Solv4U

    Poor water solubility of drug candidates is one of the most common hurdles pharmaceutical development is confronted with. Promising new chemical entities and drug candidates often fail in development due to the limitations of their solubility in water.

    Marinomed Biotech AG provides Solv4U techno...
  • Product DERMATOLOGICALS, SKIN HEALTH & UV PROTECTION

    Dermatologicals
    - High potency topical corticosteroids
    - Antifungals
    - Wound healing & burns
    - Eczema, irritations, itching
    - Xerosis and dry skin

    Skin health
    - Atopic dermatitis
    - Reactive & intolerant skin
    ...
  • Product SOMATROPIN - HHT

    Freeze dried powder for reconstitution containint Somatropin 4 IU or Somatropin 16 IU
  • Product NEW! Fillchoice® Refill KIT

    A Ready-to-Transfer CSTD for drug reconstitution and administration to the patient from one or multiple drug vials.
    • PATENDED In routine clinical practice of drug reconstitution, health care workers are at serious risk from the use of syringes with needles and exposure to the potential release o...
  • Product ASYMMETRIC HYDROGENATION

    We extensively address the specific needs of the pharmaceutical, food, cosmetics, agrochemicals and specialty chemicals industries with our capabilities in Transition Metal Catalysis (TMC) as applied to asymmetric hydrogenation. Complex active pharmaceutical ingredients (API's) are often stereochemica...
  • Product WRAPAROUND MACHINE

    Compact, powerful and easy to use, the Worldpack wraparound labeller is a high performance and extremely reliable applicator. This labeller is compact and requires no change of parts resulting in easy operation.
    http://www.worldpackmachines.com/product-detail/wraparound-machine

  • Product Media Supplements for Cell Culture, Vaccines, Diagnostics

    For more than 85 years, Kerry has been a trusted partner for quality and supply assurance to the world's leading biotechnology customers. We provide a proven portfolio of media supplements including protein hydrolysates, yeast extracts, recombinant proteins and cell line tailored supplement systems. We...
  • Product Highly Potent Pharmaceutical Principles

    Olon relies on one of the most extensive expertise in handling highly potent pharmaceutical principles at global level, has raised the level of containment up to the actual standards and very large scale putting in place a set of primary and secondary containment designed to avoid the active substances...
  • Product Clinical solutions: Trials

    Conscio's in-house clinical Unit has been operating since 2007, with more than 600 BA/BE/PK studies completed and proprietary of over 270 validated bioanalytical methods. Equipped with a 60-bed on-site clinical unit in Prague and a recently opened 36-bed unit in Ostrava, we provide comprehensive services w...
  • Product DSC; CAS# 74124-79-1 Peptide Coupling Reagent

    Coupling Reagents of peptides;  Purity(99% HPLC): 99%min;  
  • Product Land in Europe- EU Market Access Support Services

    Azierta provides global support in accesing to European Market to Non-European companies
    European Pharma market access support services: There are three main strategies that may be implemented on an individual basis, or alongside each other, depending on your company needs...
  • Product Single-Use Assemblies

    Whether you are looking for an economical standard single-use system or require a custom-designed and built single-use system, we can offer a proven solutions at every scale.

    With a wealth of experience, knowledge, and solid quality processes behind every single-use product, we strive to assure ...
  • Product Universal Mill ( Pin Mill )

    Universal Mill ( Screen Type Equipment ) is recommended for medium to fine grinding of soft to semi hard materials. Appropriately sized mill chamber prevents build-up of deposits and blockage of the mill body by fatty & sticky products. Cool powdering operation retain vital properties like colour, tast...
  • Product MENTHOL AND MINT OILS

    AOS Products Pvt Ltd offers impeccable quality of Menthol Crystals, Mint Oils, Spearmint Oil, Peppermint Oil, Indian Piperita Oil, Basil Oil and derivatives of all these Oils. We offer these products as per Indian Pharmacopeia, British Pharmacopeia, US Pharmacopeia etc.
  • Product High Speed Door

    1.    Specially designed fabric door for indoor applications requiring high frequency of operations.

    2.    High speed doors are CE certified

    3.    Special EPDM seal between lateral parts and curtains, providing complete seali...
  • Product Freeze-drying

    Freeze-dryers are equipped with Automatic Loading and Unloading System placed in Class A. Loading directly onpre-cooled shelves assures protection of temperature sensitive products. 
  • Product Clinical Trial Services: Regulatory Pathways

    Regulatory Pathways
    Develop regulatory strategyDeliver Regulatory roadmap and Pre-IND processEnsure GMP/QA/QC/QP compliance
  • Product AUTOMATIC POLISHING MACHINE

    MACHINE IS USE FOR AUTOMATIC POLISH OF TABLETING TOOLING AND DIES
  • Product Lynfinity

    LYNFINITY, Continuous Aseptic Spray Freeze Drying

    Most freeze drying in aseptic conditions is done in a freeze dryer designed for vials, or bulk product in trays. The process has traditionally been a batch process making it both time consuming and energy intensive. The LYnfinity techno...
  • Product Cell Culture Services

    FUJIFILM Diosynth Biotechnologies is a leading provider of cell culture services for biologics, advancing anddelivering life changing therapies. We offer complete solutions for cell line development, process development, late phase activities, clinical and commercial manufacturing of a wide variety of biop...
  • Product Cortellis Regulatory Intelligence™

    Navigate the regulatory landscape and efficiently drive strategic decisions with Cortellis Regulatory Intelligence. Get full and timely coverage of global health authority requirements on healthcare products such as drugs, biologics, medical devices and IVDs, and access exclusive expert reports for both in...
  • Product CRO and CDMO Solutions

    CRO and CDMO solutions: Transforming the pharmaceutical value chain for emerging biotechs and large pharmas - How integrating research and manufacturing processes enhances efficiency and accelerates time to market.
  • Product Uridine

     white crystalline powder, purity 99%min
  • Product ATS SuperTrak – Asynchronous Linear Conveyance Platform

    SuperTrak CONVEYANCE™ products include, SuperTrak GEN3™ and SuperTrak MICRO™ conveyors. SuperTrak GEN3™ and SuperTrak MICRO™ are smart enabled technologies that get machines to production faster and more effectively than traditional methods by saving significant engineering and int...
  • Product PROCESS INSTRUMENTS

    Radix Instruments are considered reliable by our customers in the pharmaceutical industry which is governed by the most stringent regulations and sets the standard for instrumentation quality. Our products will meet and exceed your expectations for process instrumentation.

    Radix Instrum...
  • Product Vials

    Mefar ilac sanayii offers wide range of products including vial filling between 2 ml through 300 ml.
    Mefar's all services have EMA certification.

    Contact us for more information.
  • Product Facility Planning

    Csv Life Science can support customers  in all phases of the project, right from the very beginning. This includes facility planning activities, aimed to a better and conscious defnition of your new or upgraded process needs

  • Product L-Glutathione Reduced

    L-Glutathione Reduced is a tripeptide which consists of glutamic acid, cysteine, and glycin.

    The L-Glutathione Enriched Yeast obtained via microbial fermentation, then obtain the L-Glutathione Reduced by modern technology's separation and purification .

  • Product improve sleeping tablets

    Ulimited color and flavors

    We use natural color and flavors extracted directly from the natural source or mixed with various natural sources.

  • Product Trimeik

    Perindopril / Indapamide / Amlodipine
  • Product Nitrosamines - Quantitive Quality Control

    LC-MS/MS methods are nowadays commonly used for nitrosamines analysis in all types of materials, since it allows analyte-specific detection based on both retention time and structurally specific fragmentation information in conjunction with high sensitivity.

    After the establishment of the ni...
  • Product GCP Services(Good Clinical Practices)

    We offer various GCP services which can help the clients across globe, ranging from audits to monitoring services. We provide comprehensive GCP Quality Compliance services to the pharmaceutical industry. Our GCP consulting services are characterized by:

    1) Knowledge: Various regulatory requi...