menu
    • menu

    Company profile for Aspen API

    Aspen API-PSE
    News
    Leader in CADIFA approval

    28 Feb 2025

    // PRESS RELEASE

    Saving costs & producing sustainably, success Femke’s internship

    11 Feb 2025

    // PRESS RELEASE

    Nieké van Gils, Jr. scientist at Aspen API on international women’s day.

    07 Mar 2024

    // PRESS RELEASE

    DATA COMPILATION
    #PharmaFlow

    Aspen API 250

    Contact Supplier

    Website

    CPhI Korea

    Attending

    Book a meeting

    envelop Contact Supplier

    Latest Content

    https://www.youtube.com/embed/FtJMUBXCX_c

    EVENTS

    DIGITAL CONTENT

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    FINISHED DOSAGE FORMULATIONS

    Key Products KEY PRODUCTS

    SERVICES

    Key Products KEY SERVICES

    EXCIPIENTS

    INSPECTIONS & REGISTRATIONS

    PharmaCompass

    Aspen API. More than just an API™

    Related CompaniesRelated Companies

    About

    Aspen API is the cooperative entity formed by Aspen Oss in the Netherlands and Fine Chemicals Corporation in South Africa. With quality, compliance, and teamwork at its core, Aspen API works tirelessly to deliver top-quality APIs to clients worldwide. Aspen API has a portfolio of over 58 high-quality APIs, including high potency, oncology, peptides, narcotics, analgesics, botanical extractions, and biochemicals. Aspen API places a strong emphasis on sustainability. It employs eco-friendly technologies and solvents in its chemical processes, ensuring responsible and environmentally conscious manufacturing.

    CONTACT DETAILS

    Click the arrow to open the dropdown
    Contact SupplierContact
    Google MapGoogle Map
    Full View ScreenFull View Screen
    Aspen APINetherlands1 Flag
    Country
    Country
    Netherlands
    Address
    Address
    Kloosterstraat 6, 5349 AB Oss
    Telephone
    Telephone
    +31 882779000
    Client Email
    Email
    api@nl.aspenpharma.com
    Client Website
    Website
    https://www.aspenapi.com/
    Linkedin
    Linkedin
    https://www.linkedin.com/company/aspen-api/
    youtube
    YouTube
    https://www.youtube.com/@aspenapi
    Twitter
    Twitter
    Contact Info
    Others

    Events

    Webinars & Exhibitions

    Request a meetingRequest a meeting
    Full Screen ViewFull Screen View
    Default Event

    CPhI Korea

    Attending

    envelop Contact Supplier

    CPhI Korea

    Contact Supplier

    Meeting

    Digital content read-more

    Explore the latest content creation from this company

    CORPORATE CONTENT #SupplierSpotlight

    Product List 2024

    read-more

      https://www.pharmacompass.com/pdf/party/content/aspen-api-party-content-73017.pdf

      Open PDFOpen PDF
      UploadUpload
      Key ShareShare

    Corporate Presentation

    read-more

      https://www.pharmacompass.com/pdf/party/content/aspen-api-party-content-26315.pdf

      Open PDFOpen PDF
      UploadUpload
      Key ShareShare

    ISO 45001:2018

    read-more

      https://www.pharmacompass.com/pdf/party/content/aspen-api-party-content-68985.pdf

      Open PDFOpen PDF
      UploadUpload
      Key ShareShare

    ISO 14001:2015

    read-more

      https://www.pharmacompass.com/pdf/party/content/aspen-api-party-content-87973.pdf

      Open PDFOpen PDF
      UploadUpload
      Key ShareShare

    Ecovadis Certificate

    read-more

      https://www.pharmacompass.com/pdf/party/content/aspen-api-party-content-14530.pdf

      Open PDFOpen PDF
      UploadUpload
      Key ShareShare

    Peptide Development and Manufacturing Capabilities

    read-more

      https://www.pharmacompass.com/pdf/party/content/aspen-api-party-content-84971.pdf

      Open PDFOpen PDF
      UploadUpload
      Key ShareShare

    Green Continuous LPPS

    read-more

      https://www.pharmacompass.com/pdf/party/content/aspen-api-party-content-56000.pdf

      Open PDFOpen PDF
      UploadUpload
      Key ShareShare

    GMP Certificate 2023

    read-more

      https://www.pharmacompass.com/pdf/party/content/aspen-api-party-content-88373.pdf

      Open PDFOpen PDF
      UploadUpload
      Key ShareShare

    Green Answer to Peptide Synthesis

    read-more

      https://www.pharmacompass.com/pdf/party/content/aspen-api-party-content-1643862074.pdf

      Open PDFOpen PDF
      UploadUpload
      Key ShareShare

    Your Personal API Partner

    read-more

      https://www.pharmacompass.com/pdf/party/content/aspen-api-party-content-1640586320.pdf

      Open PDFOpen PDF
      UploadUpload
      Key ShareShare

    DATA COMPILATION #PharmaFlow

    read-more
    read-more
    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Every year, the US Food and Drug Administration (FDA) publishes the user fee amounts it will collect from manufacturers of pharmaceuticals, generic drugs, biosimilars and medical devices in the coming financial year. The fee for fiscal year 2025 under the Generic Drug User Fee Act (GDUFA) was published on July 31, 2024.The GDUFA, established in 2012, authorizes FDA to assess and collect fees from drug manufacturers to expedite the delivery of safe, high-quality, and affordable generic drugs to the American public.The FDA’s facility payments list under GDUFA reveals that as of November 14, 2024, 1,397 facilities had paid their registration fees for financial year 2025. Of these facilities, 707 or 50.6 percent are active pharmaceutical ingredients (API) facilities, 405 or 29 percent are finished dosage forms (FDF) facilities, 69 (4.9 percent) are facilities that produce both APIs and FDFs, and 216 (15.5 percent) are contract manufacturing services (CMO) sites.Teva Pharmaceuticals, with 29 facility registrations, led the list of companies, followed by Aurobindo Pharma, Sun Pharma, and Dr. Reddy's Laboratories. Fiscal year Facility Registrations 2016 1,425 2017 1,442 2018 1,269 2019 1,286 2020 1,300 2021 1,340 2022 1,385 2023 1,394 2024 1,447 2025 1,397  Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available)India continues to lead with 396 facilities, US and China follow India maintains its dominance in total facility registrations with the FDA, registering 396 facilities for FY2025. This includes 214 API facilities, 135 FDF facilities, 21 facilities engaged in both API and FDF activities, and 26 CMO facilities.The United States holds the second position with 328 facilities, while China strengthened its third position with 197 facilities.With 214 API facilities, India continues to have the largest share of API manufacturing sites, outmatching the combined total of China (128) and the US (83), which together account for 211 facilities. Among European manufacturers, Italy leads with 59 API manufacturing sites, followed by Spain (30) and Germany (25).The US has maintained its lead in FDF facilities with 143 sites, followed closely by India with 135 sites and China with 45 sites. Country API FDF Both CMO Total India 214 135 21 26 396 US 83 143 13 89 328 China 128 45 12 12 197 Italy 59 3 2 19 83 Germany 25 4 1 15 45 Spain 30 9 1 4 44 Canada 7 17   13 37 Taiwan 9 6 5 4 24 Switzerland 15 4   4 23 France 16     6 22 Japan 18   1   19 United Kingdom 12 1   2 15 Mexico 9 1   1 11 Ireland 5 5   1 11   Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) GDUFA III user fee rates increase across categories for FY25The GDUFA, which was reauthorized on September 30, 2022 (as GDUFA III), continues with provisions that will last until September 30, 2027. In July 2024, the FDA published updated user fee rates for FY2025.The facility fees have seen increases across all categories. API facility fees increased by 3 percent for domestic sites (to US$ 41,580) and 2 percent for foreign sites (to US$ 56,580). FDF facility fees rose by 5 percent for both domestic (to US$ 231,952) and foreign sites (to US$ 246,952). CMO facility fees increased by 5 percent for domestic sites (to US$ 55,668) and 4 percent for foreign sites (to US$ 70,668).Additionally, the fee for large-, medium- and small-sized drug applicants has increased by over 9 percent, compared to the 7 percent increase seen in 2023. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) China leads new facility registrations as FDA records 41 new units in FY25Out of the total 1,397 facilities registered for FY2025, 41 were new registrations (going by Facility FDA Establishment Identifier numbers). China led the way with 13 new facilities, followed closely by India with 11 new facilities, while the US secured the third position with eight new facilities.The new registrations included 15 API facilities, 13 CMO facilities, 12 FDF facilities, and one facility engaged in both API and FDF activities. Chinese companies dominated the new FDF registrations with six facilities: Chengdu Shuode Pharma, Chengdu Suncadia Medicine, Cipla (Jiangsu), GE Healthcare (Shanghai), Luoxin Aurovitas Pharma (Chengdu), and Zhejiang Xianju Pharma.India added two new FDF facilities through Eugia Steriles and Zydus Pharma. Malaysia registered two FDF facilities through Novugen Pharma and Novugen Oncology, while Turkey’s Insud Pharma subsidiary Exeltis and US’ RK Pharma registered one FDF facility each.The 13 new CMO facilities included, Acme Generics, Emcure, Esjay Pharma, Fordoz Pharma, Fourrts Laboratories, Laboratoires KABS, PharmaMax, Quality Packaging Specialists International, Ritsa Pharma, Shanghai Aucyun Pharma, Sichuan Huiyu Pharma, Taejoon Pharm, and Tubilux Pharma.In the API category, the 15 new registrations included Acharya Chemicals, Hainan Poly Pharma, CBL Patras, EUROAPI, Hybio Pharma, Medilux Laboratories, Metrochem API, Purolite, Chengdu Easton Biopharma, Sionc Pharma, Smithfield Bioscience, Xttrium Laboratories, Zhejiang Hengkang Pharma, Moehs Iberica and Shilpa Pharma. Armstrong Pharmaceuticals registered the sole facility for both APIs and FDFs.So far, 92 facilities have not renewed their registration. Among these was a facility owned by Sandoz subsidiary Eon Labs in Wilson, North Carolina (US), which is permanently closed. In fact, the geographical distribution of non-renewals shows that 30 facilities were from the US, while India and China accounted for 14 and nine non-renewals respectively. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) Our viewThe FY 2025 GDUFA facility registration data indicates a continued strong presence of Indian manufacturers in the US generic drug market, particularly in API production. However, China's leadership in new facility registrations, especially in FDF manufacturing, suggests that the global generic drug supply chain landscape may evolve considerably in the coming years. 
    subscribeSubscribe
    ExcelExcel Download

    Impressions: 14024

    https://www.pharmacompass.com/radio-compass-blog/chinese-fda-registered-generic-facilities-gain-steam-india-maintains-lead-with-396-facilities

    #PharmaFlow by PHARMACOMPASS
    21 Nov 2024
    Share Share
    CDMO Activity Tracker: Novo’s parent buys Catalent for US$ 16.5 bn; Fujifilm, Merck KGaA, Axplora expand capabilities

    CDMO Activity Tracker: Novo’s parent buys Catalent for US$ 16.5 bn; Fujifilm, Merck KGaA, Axplora expand capabilities

    During the first half (H1) of 2024, the global contract development and manufacturing organization (CDMO) landscape was driven by the escalating demand for complex drug development and manufacturing.With the industry grappling with constantly evolving therapeutic modalities, CDMOs are racing to invest in cutting-edge technologies and infrastructure to meet the growing needs of pharmaceutical and biotech companies.Some of the key players in the CDMO space are Catalent, EUROAPI, Lonza, Axplora, Thermo Fisher, SEQENS, Samsung Biologics, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Famar, LGM Pharma, Veranova, and Evonik. View CDMO Activity Tracker for H1 2024 (Free Excel Available)Novo’s parent buys Catalent for US$ 16.5 bn; Bora, Lonza, Siegfried expand US footprintDuring H1 2024, several European and Asian drugmakers expanded their footprints in the US. In February, Novo Nordisk’s parent company, the Novo Nordisk Foundation, announced the acquisition of Catalent through its investment arm Novo Holdings for US$ 16.5 billion. Novo Holdings plans to sell three of Catalent’s “fill-finish” sites to Novo Nordisk for US$ 11 billion. The deal is expected to allow the Danish drugmaker “to serve significantly more people living with diabetes and obesity,” a company statement said.Taiwan-headquartered Bora Pharmaceuticals forged ahead with its expansion plans in the US market by acquiring Minnesota-based generics manufacturer Upsher-Smith Laboratories. Emergent BioSolutions said it is selling its Maryland facility to an affiliate of Bora. This site in Camden is part of its CDMO, Emergent Bioservices, and offers clinical and commercial non-viral aseptic fill/finish services on four fill lines, including lyophilization, formulation development, and support services.Swiss drugmaker Lonza has agreed to acquire Genentech’s manufacturing facility in California, US, from Roche for US$ 1.2 billion in cash. The site, located in the city of Vacaville, is one of the largest biologics manufacturing facilities in the world by volume.Lonza also launched an artificial intelligence-driven route design technology for choosing the optimal synthetic pathway to manufacture novel APIs.Switzerland’s Siegfried is acquiring a Wisconsin (US)-based CDMO that specializes in early-phase development and manufacturing services from Curia Global to strengthen its capabilities in North America. Siegfried will further develop the site into its North American Siegfried Acceleration Hub for early-phase CDMO services. View CDMO Activity Tracker for H1 2024 (Free Excel Available) Merck Millipore, SK Bioscience lead CGT boom; Fujifilm, Axplora, expand CDMO capabilitiesThe burgeoning field of cell and gene therapies (CGTs) is driving significant investments in CDMOs. CGTs saw considerable deal-making too. Merck KGaA agreed to buy Wisconsin-based Mirus Bio for US$ 600 million. Mirus Bio is a specialist in the development and commercialization of transfection reagents that are used to help introduce genetic material into cells. These reagents play a key role in the production of viral vectors for CGTs.Similarly, South Korea’s SK Bioscience acquired a 60 percent stake in IDT Biologika GmbH for KRW 339 billion (US$ 244 million). IDT Biologika is a 104-year-old German company that ranks among the top 10 vaccine producers in the world.CDMOs are also expanding their capabilities in order to lead innovation for their pharmaceutical partners. Fujifilm Diosynth Biotechnologies is investing US$ 1.2 billion in its large-scale cell culture CDMO business to further expand its end-to-end bio-manufacturing facility in North Carolina, bringing the total investment in the facility to over US$ 3.2 billion. Similarly, Merck KGaA owned MilliporeSigma made its biggest investment in the Asia-Pacific region in March when it invested € 300 million (US$ 327 million) in a new bioprocessing production center in Daejeon, South Korea.German CDMO giant Axplora is investing € 8 million (US$ 8.73 million) to expand capacity for antibody drug conjugate (ADC) payload manufacturing at its Le Mans site in France. Catalent completed upgrades to its capsule filling capabilities of dry powders for inhalation to handle potent drugs at its Boston facility. This now positions Catalent as the CDMO with the largest GMP capacity for capsule spray-dried and carrier-based inhaled powders.LGM Pharma increased its Analytical Testing Services (ATS) by 50 percent with a US$ 2 million investment and introduced new suppository manufacturing capabilities to its CDMO portfolio. Minakem has invested in a new production unit in Montreal, Canada, for steroid APIs. View CDMO Activity Tracker for H1 2024 (Free Excel Available) EUROAPI kicks off four-year sweeping plan; LegoChem partners Samsung Biologics for ADC programSanofi’s spinoff EUROAPI marked 2024 as a “transition year”, setting in motion its Focus-27 plan for profitable growth in the future. The sweeping four-year plan includes a streamlined value-added portfolio focused on highly differentiated and profitable APIs, and a CDMO focused on late-stage and high-value complex small molecules and tides supported by unique technological platforms. The leading French small molecules player signed a five-year collaboration with Ireland’s Priothera wherein EUROAPI will develop and industrialize the manufacturing process of an innovative, complex molecule for blood cancers – mocravimod. The project will be carried out at EUROAPI’s site in Budapest, which is its center of excellence for complex chemistry.South Korea’s CDMO powerhouse Samsung Biologics has partnered LegoChem Biosciences and will provide antibody development and drug substance manufacturing services as a part of LegoChem’s ADC program designed to treat solid tumors. LegoChem aims to submit an investigational new drug application to the US Food and Drug Administration (FDA) in the first half of 2025. Aurigene and Vipergen have joined forces to offer DNA-encoded library (DEL) screening for drug discovery. By combining Aurigene’s drug discovery capabilities with Vipergen’s DEL screening technologies, they seek to create a powerful tool that can quickly test over a billion small-molecule compounds against different disease targets. Dr. Reddy’s Laboratories’ company Aurigene also inaugurated its biologics facility spread across 70,000 square feet.Chinese biotech startup Pleryon is collaborating with France’s SEQENS, a leader in specialty ingredients, to develop and manufacture the former’s lead candidate, an innovative polymer to treat osteoarthritis. Famar is collaborating with Lavipharm and will serve as the contract manufacturer for the latter’s recently added analgesic pharmaceutical products — Lonarid N and Lonalgal. View CDMO Activity Tracker for H1 2024 (Free Excel Available) Our view Key trends observed in H1 2024 include a surge in investments for fill-finish facilities, a growing emphasis on cell and gene therapies, and advancements in ADC manufacturing. With the proliferation of these new classes of drugs, the CDMO space has been rapidly changing in recent years. In the future, the integration of digital technologies, such as AI and automation, will be a key differentiator for CDMOs looking to optimize their operations and accelerate drug development timelines. 
    subscribeSubscribe
    ExcelExcel Download

    Impressions: 4193

    https://www.pharmacompass.com/radio-compass-blog/cdmo-activity-tracker-novo-s-parent-buys-catalent-for-us-16-5-bn-fujifilm-merck-kgaa-axplora-lonza-expand-capabilities

    #PharmaFlow by PHARMACOMPASS
    08 Aug 2024
    Share Share

    COMPANY BIO #AboutSupplier

    read-more
    read-more
    Overview of high potency APIs or HPAPI contract manufacturing services & more on Aspen API's CDMO services for cytotoxic HPAPIs on PharmaCompass.
    Overview of high potency APIs or HPAPI contract manufacturing services & more on Aspen API's CDMO services for cytotoxic HPAPIs on PharmaCompass.
    Overview of high potency APIs or HPAPI contract manufacturing services & more on Aspen API's CDMO services for cytotoxic HPAPIs on PharmaCompass.Q1. What is a highly potent API (HPAPI)?Highly potent active pharmaceutical ingredient (HPAPI) is a c...
    #LearnMore
    July, 2022
    Share Share
    Overview of high potency APIs or HPAPI contract manufacturing services & more on Aspen API's CDMO services for cytotoxic HPAPIs on PharmaCompass.

    Overview of high potency APIs or HPAPI contract manufacturing services & more on Aspen API's CDMO services for cytotoxic HPAPIs on PharmaCompass.

    Overview of high potency APIs or HPAPI contract manufacturing services & more on Aspen API's CDMO services for cytotoxic HPAPIs on PharmaCompass.Q1. What is a highly potent API (HPAPI)?Highly potent active pharmaceutical ingredient (HPAPI) is a compound that elicits a biological response at a much smaller dose, such as a daily therapeutic dose of <10 mg. High potency drugs have the ability to bind selectively at low doses to specific receptors or inhibit specific enzymes as part of cancer or hormonal therapies.High-potency APIs (HPAPIs) require multi-step processes or semi-synthesis along with special handling requirements due to toxicity. HPAPI development and production require specialized considerations in facility design, equipment, operation and process safety to achieve the requisite level of containment. It also presents major handling challenges for innovators and manufacturing companies.High-potency APIs (HPAPIs) are becoming increasingly popular and companies are now looking for flexible containment solutions to help address their needs. However, if the current HPAPI development continues to show more efficacy, high potent API is likely to become one of the most dominant areas in the industry. High potency API (HPAPI) is prominent in oncology research and hence represents an increasingly significant share of the pharmaceutical drug pipeline.Because a growing number of pharmaceutical products contain highly potent active pharmaceutical ingredients (HPAPI) , demand for the production of HPAPIs has increased. Estimates suggest the global HPAPI market will register a strong growth over the next 5-10 years. In addition to cancer, highly potent API (HPAPI) is being used in hormonal imbalance drugs, cardiovascular drugs, central nervous system drugs and musculoskeletal drugs.The challenges in HPAPI manufacturing have also increased, along with investments, in terms of specialized containment areas and procedures to prevent personnel and environmental exposure.  A pharmaceutical CDMO has the capability to offer highly potent small molecule development services and HPAPI Contract Manufacturing Services.Integrated CDMOs have capabilities to offer both production & development services for highly potent APIs (HPAPIs), and to scale-up for HPAPI (highly potent API) development from lab quantities to large-scale volumes. The main advantage of outsourcing HPAPI contract manufacturing services is that it eliminates the need to invest in costly containment infrastructure that can also be difficult to engineer, install and maintain and it can offer HPAPIs, ADCs, highly potent small molecule development services along with manufacturing.Q2. How are the different containment challenges addressed for high-potency APIs (HPAPIs)?HPAPI can be a small-molecule, a biologic, or a hybrid of two molecules, such as an antibody-drug conjugate that links a cytotoxic small molecule to a monoclonal antibody. The cytotoxic nature of highly potent APIs presents significant challenges in terms of safe handling and containment during process scale-up and development, clinical and large-scale production of highly potent APIs (HPAPIs). Hence, HPAPIs require heavy investments for the implementation of specialized containment facilities.Additionally, the cGMP manufacturing of high-potency active pharmaceutical ingredients (HPAPIs) requires an isolated environment that is equipped with isolators and cleanrooms. Working with an experienced pharmaceutical outsourcing organization such as a CMO or CDMO for contract manufacturing of highly potent compounds can help eliminate challenges like investing in expensive infrastructure and the cost of training staff for the production of a highly potent API (HPAPI). Such outsourcing organizations can also offer highly potent intermediates and active pharmaceutical ingredients, ADCs, biologics, large molecule, highly potent small molecule development services along with other contract manufacturing services.HPAPI containment challenges can be handled through the following ways:   One of the largest areas for consideration is equipment. All HPAPI handling and development systems must be tested and verified to meet the necessary isolation requirements while developing and manufacturing high potent active pharmaceutical ingredients (HPAPI). The capability of equipment, systems and procedures to contain and isolate materials under expected operating conditions must be verified as it is a critical component of the overall HPAPI handling and development program.   There must be a close evaluation of the compound for potential toxicity, potency and hazards while developing and manufacturing high potent active pharmaceutical ingredients (HPAPI). By applying rigorous engineering controls within the process scale-up and development, high-quality high potent active pharmaceutical ingredients (HPAPIs) can be produced without adverse effects.   Specialized considerations in facility design, equipment, operation and process scale-up and development as well as safety are needed to achieve the desired level of containment of high potency API (HPAPI) and drug products. It is necessary to carry out a careful assessment of the hazards posed by each product, reagent and intermediate involved in the synthesis before cGMP manufacturing.   To identify the exposure potential, factors including the quantity of material to be handled, the percentage of high potent active pharmaceutical ingredients (HPAPI) and any excipient components, along with the task duration should be considered.Q3. How do contract development and manufacturing organizations (CDMOs) help in the production of HPAPIs?High potency active pharmaceutical ingredient (HPAPI) is a growing area for pharmaceutical manufacturers. Around a third of all drugs in the pharmaceutical pipeline are categorized as high potency active pharmaceutical ingredients (HPAPIs). However, HPAPIs have strict handling requirements that require high capital investment and specialized personnel to develop. Producing ADC, which requires conjugation of a small molecule to a large biomolecule, is even more challenging.Highly potent compounds present numerous challenges in terms of preventing cross-contamination during developing and manufacturing high potent active pharmaceutical ingredients (HPAPIs). As a result, many HPAPI investigators turn to contract development and manufacturing organizations (CDMOs) and CMOs who have the facilities, equipment and personnel in place to take their projects through HPAPI development and manufacturing.While many CDMOs have made significant investments in their highly potent API (HPAPI) capabilities over the last two decades to provide reliable support throughout all project stages, including process scale-up and development, clinical and commercial cGMP manufacturing. A pharmaceutical CMO or CDMO has capabilities such as isolator design, laboratory design and containment practices that are critical for safe HPAPI and cytotoxic drugs manufacturing.Most HPAPIs in clinical development are outsourced to contract development and manufacturing organizations (CDMOs) that have the necessary process expertise, qualified facilities for the production of highly potent intermediates and active pharmaceutical ingredients.Points to consider while choosing a CDMO for HPAPI development and Manufacturing:   Any CDMO considered as an HPAPI production partner should have experience in the field and a long track record of successfully manufacturing and handling potent compounds, including highly potent intermediates and active pharmaceutical ingredients.   There should be clear evidence of regulatory expertise and a positive compliance history.   The appropriate containment strategy should be selected for HPAPI (highly potent API) development and manufacturing based on scale. CDMO facilities should include cGMP compliant isolator systems (OEL 0.1 µg/m³) for high-potent raw materials, intermediates and APIs.   The ability of a CDMO to support projects for developing and manufacturing high potent active pharmaceutical ingredients (HPAPIs) through commercialization as well as extensive analytical capabilities are quite important. These factors are indicators of long-term commitment to HPAPI production.   CDMO facilities should be designed with containment strategies based primarily on engineering controls, such as equipment and procedures, ventilation, chemical contaminants, etc. and administrative solutions (processes and PPE) as secondary measures.   Also, rigorous safety, health and environmental (SHE) practices, along with Occupational Exposure Band (OEB) and Occupational Exposure Limit (OEL) based controls, need to be established to protect workers, materials, machines and the environment.Q4. What HPAPI manufacturing services does Aspen API offer?Aspen API is a contract development & manufacturing organization (CDMO) that provides development, upscaling and commercial manufacturing for complex high potency API (HPAPI), peptide APIs, oncology APIs, cytotoxic APIs, along with narcotics and other established APIs. Aspen API has over 58 high-quality APIs available, ranging from high potency, oncology, peptides, narcotics, analgesics and botanical extraction to biochemical APIs.At Aspen API, CDMO or CMO API projects are in excellent hands. Aspen API can add value to the client's projects and collaborate with the client to ensure success. It has a century-long history in development, upscaling and commercially manufacturing complex high potency APIs (HPAPIs), oncology APIs, peptides, along with narcotics and other established APIs. Whether the project is for a New Chemical Entity (NCE) or a process for (re-)designing (intermediate) API, Aspen API is the perfect partner to manage projects - from the development phase to the commercial implementation. Aspen API adds expertise, innovation, compliance, registration and partnership to the client's projects.Aspen API's facilities are successfully inspected and approved by regulatory authorities such as US FDA, EDQM, PMDA and others. It  has expertise in manufacturing high potency API (HPAPI) and oncology APIs. Supported by a robust quality system, Aspen API produces high-quality products, which are manufactured in compliance with cGMP, ICH and safety, health and environmental (SHE) regulations.At both Aspen Oss and Fine Chemicals Corporation, high potent APIs are produced in units with OEB 4 and 5 classifications. Aspen API has a long history of working with Occupational Exposure Limit (OEL) levels, from as low as 0.01 µg/m³. Its heritage in manufacturing complex highly potent active pharmaceutical ingredients (HPAPIs) has enabled Aspen API to establish world class systems and procedures for safe HPAPI handling and development. At Fine Chemicals Corporation, high potent active pharmaceutical ingredients (HPAPI) and cytotoxic product manufacturing is carried out in a dedicated purpose-built facility.Manufacturing capabilities   Manufacturing under full cGMP   Batches ranging from 1 kg to 500 kg active pharmaceutical ingredient (API)   Commercial manufacturing ranging from 100 to 10.000 liters   Best-in-class cleaning procedures   Isolator technology for micronization and milling of Occupational Exposure Band (OEB) 4 and 5 compounds for HPAPI Manufacturing   Grade D clean room manufacturing for weighing and dispensingIntegration in processes   In-house safety, health and environmental (SHE) specialists with expert knowledge   Well-trained staff and best-in-class safety protocols   Safety assessments using calorimetry on processes, intermediates and active pharmaceutical ingredients (APIs)   All intermediates and active pharmaceutical ingredients (APIs) on site assigned to Occupational Exposure Band (OEB) category   ISO14001 and ISO 45001 certified

    Impressions: 2261

    NEWS #PharmaBuzz

    read-more
    read-more
    Leader in CADIFA approval
    Leader in CADIFA approval

    28 Feb 2025

    // PRESS RELEASE

    https://www.aspenapi.com/news/leader-in-cadifa-approval/

    PRESS RELEASE
    28 Feb 2025
    Share Share
    Saving costs & producing sustainably, success Femke’s internship
    Saving costs & producing sustainably, success Femke’s internship

    11 Feb 2025

    // PRESS RELEASE

    https://www.aspenapi.com/news/this-project-aimed-to-optimize-the-purification-process-of-desogestrel/

    PRESS RELEASE
    11 Feb 2025
    Share Share
    Nieké van Gils, Jr. scientist at Aspen API on international women’s day.
    Nieké van Gils, Jr. scientist at Aspen API on international women’s day.

    07 Mar 2024

    // PRESS RELEASE

    https://www.aspenapi.com/news/nieke-van-gils-jr-scientist-at-aspen-api-on-international-womens-day/

    PRESS RELEASE
    07 Mar 2024
    Share Share
    Gold Medal for Aspen API in EcoVadis Evaluation
    Gold Medal for Aspen API in EcoVadis Evaluation

    31 Oct 2023

    // PRESS RELEASE

    https://www.aspenapi.com/news/gold-medal-for-aspen-api-in-ecovadis-evaluation/

    PRESS RELEASE
    31 Oct 2023
    Share Share
    Fine Chemicals Corporation facility in Cape Town, South Africa was inspected by the PMDA.
    Fine Chemicals Corporation facility in Cape Town, South Africa was inspected by the PMDA.

    31 Oct 2023

    // PRESS RELEASE

    https://www.aspenapi.com/news/fine-chemicals-corporation-facility-in-cape-town-south-africa-was-inspected-by-the-pmda/

    PRESS RELEASE
    31 Oct 2023
    Share Share
    Get to know the Aspen API sales managers! Interview with Ivette Cosme – Sales manager Aspen API
    Get to know the Aspen API sales managers! Interview with Ivette Cosme – Sales manager Aspen API

    05 Jul 2023

    // PRESS RELEASE

    https://www.aspenapi.com/news/get-to-know-the-aspen-api-sales-managers-interview-with-ivette-cosme-sales-manager-aspen-api/

    PRESS RELEASE
    05 Jul 2023
    Share Share

    USDMF

    read-more
    read-more

    01

    16-alpha-hydroxyprednisolone

    Netherlands
    arrow
    CPhI Korea
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAspen API. More than just an API™

    Aspen API

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 8855

    Submission : 1990-11-26

    Status : Active

    Type : II

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    02

    Azathioprine

    South Africa
    arrow
    AGGSpend
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Fine Chemicals Corporation PTY Ltd

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 10119

    Submission : 1993-02-19

    Status : Active

    Type : II

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    03

    Azathioprine (process 3)

    Netherlands
    arrow
    CPhI Korea
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAspen API. More than just an API™

    Aspen API

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 34647

    Submission : 2020-09-18

    Status : Active

    Type : II

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    04

    Baclofen

    Netherlands
    arrow
    CPhI Korea
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAspen API. More than just an API™

    Aspen API

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 6421

    Submission : 1986-06-18

    Status : Active

    Type : II

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    05

    Baclofen (process 2)

    Netherlands
    arrow
    CPhI Korea
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAspen API. More than just an API™

    Aspen API

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35224

    Submission : 2020-10-16

    Status : Active

    Type : II

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    06

    Benztropine Mesylate

    Netherlands
    arrow
    CPhI Korea
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAspen API. More than just an API™

    Aspen API

    GDUFA

    DMF Review : Complete

    Rev. Date : 2012-10-25

    Pay. Date : 2012-12-19

    DMF Number : 6914

    Submission : 1987-04-09

    Status : Active

    Type : II

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    07

    Budesonide

    Netherlands
    arrow
    CPhI Korea
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAspen API. More than just an API™

    Aspen API

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 10493

    Submission : 1993-09-23

    Status : Active

    Type : II

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    08

    Buprenorphine Hydrochloride

    Netherlands
    arrow
    CPhI Korea
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAspen API. More than just an API™

    Aspen API

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 7099

    Submission : 1987-08-06

    Status : Active

    Type : II

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    09

    Conjugated Estrogens Type Cn

    Netherlands
    arrow
    CPhI Korea
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAspen API. More than just an API™

    Aspen API

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 34883

    Submission : 2020-06-09

    Status : Active

    Type : II

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    10

    Danaparoid Sodium

    Netherlands
    arrow
    CPhI Korea
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAspen API. More than just an API™

    Aspen API

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 10519

    Submission : 1993-10-08

    Status : Inactive

    Type : II

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    Only 10 entries up to this point, click to access all click full view read-more
    click full view
    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    JDMF

    read-more
    read-more

    01

    Budesonide

    Netherlands
    arrow
    CPhI Korea
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothAspen API. More than just an API™

    Contact Supplier Contact Supplier
    Flag Netherlands
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Aspen API

    Registration Number : 301MF10061

    Registrant's Address : Kloosterstraat 6, 5349 AB Oss, the Netherlands

    Initial Date of Registration : 2019-09-11

    Latest Date of Registration : 2022-10-19

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    02

    Budesonide

    Netherlands
    arrow
    CPhI Korea
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothAspen API. More than just an API™

    Contact Supplier Contact Supplier
    Flag Netherlands
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Aspen API

    Registration Number : 305MF10040

    Registrant's Address : Kloosterstraat 6, 5349 AB Oss, the Netherlands

    Initial Date of Registration : 2023-03-29

    Latest Date of Registration : 2023-03-29

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    03

    Desogestrel

    Netherlands
    arrow
    CPhI Korea
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothAspen API. More than just an API™

    Contact Supplier Contact Supplier
    Flag Netherlands
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Aspen API

    Registration Number : 303MF10070

    Registrant's Address : Kloosterstraat 6, 5349 AB Oss, the Netherlands

    Initial Date of Registration : 2021-04-22

    Latest Date of Registration : 2021-04-22

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    04

    Estradiol

    Netherlands
    arrow
    CPhI Korea
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothAspen API. More than just an API™

    Contact Supplier Contact Supplier
    Flag Netherlands
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Aspen API

    Registration Number : 218MF10586

    Registrant's Address : Kloosterstraat 6, 5349 AB Oss, the Netherlands

    Initial Date of Registration : 2006-06-22

    Latest Date of Registration : 2022-04-20

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    05

    Estriol

    Netherlands
    arrow
    CPhI Korea
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothAspen API. More than just an API™

    Contact Supplier Contact Supplier
    Flag Netherlands
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Aspen API

    Registration Number : 218MF10506

    Registrant's Address : Kloosterstraat 6, 5349 AB Oss, the Netherlands

    Initial Date of Registration : 2006-05-15

    Latest Date of Registration : 2024-11-13

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    06

    Ethinyl estradiol

    Netherlands
    arrow
    CPhI Korea
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothAspen API. More than just an API™

    Contact Supplier Contact Supplier
    Flag Netherlands
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Aspen API

    Registration Number : 218MF10848

    Registrant's Address : Kloosterstraat 6, 5349 AB Oss, the Netherlands

    Initial Date of Registration : 2006-10-20

    Latest Date of Registration : 2007-07-26

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    07

    Fentanyl

    South Africa
    arrow
    AGGSpend
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    Contact Supplier Contact Supplier
    Flag South Africa
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Fine Chemicals Corporation PTY Ltd

    Registration Number : 227MF10059

    Registrant's Address : 15 Hawkins Avenue, Epping 1,7460, Cape Town, South Africa

    Initial Date of Registration : 2015-03-06

    Latest Date of Registration : 2024-03-13

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    08

    Leuprorelin acetate

    Netherlands
    arrow
    CPhI Korea
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothAspen API. More than just an API™

    Contact Supplier Contact Supplier
    Flag Netherlands
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Aspen API

    Registration Number : 224MF10165

    Registrant's Address : Kloosterstraat 6, 5349 AB Oss, the Netherlands

    Initial Date of Registration : 2012-08-16

    Latest Date of Registration : 2012-08-16

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    09

    Mirtazapine

    Netherlands
    arrow
    CPhI Korea
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothAspen API. More than just an API™

    Contact Supplier Contact Supplier
    Flag Netherlands
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Aspen API

    Registration Number : 219MF10237

    Registrant's Address : Kloosterstraat 6, 5349 AB Oss, the Netherlands

    Initial Date of Registration : 2007-07-17

    Latest Date of Registration : 2020-01-31

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    10

    Norethisterone

    Netherlands
    arrow
    CPhI Korea
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothAspen API. More than just an API™

    Contact Supplier Contact Supplier
    Flag Netherlands
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Aspen API

    Registration Number : 218MF10846

    Registrant's Address : Kloosterstraat 6, 5349 AB Oss, the Netherlands

    Initial Date of Registration : 2006-10-20

    Latest Date of Registration : 2021-05-24

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    Only 10 entries up to this point, click to access all click full view read-more
    click full view
    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    KDMF

    read-more
    read-more

    01

    Budesonide

    Netherlands
    arrow
    CPhI Korea
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAspen API. More than just an API™

    Aspen API

    Registrant Name : Synex Co., Ltd.

    Registration Date : 2021-07-22

    Registration Number : 20210722-209-J-1071

    Manufacturer Name : Aspen Oss BV

    Manufacturer Address : Veersemeer 4, Oss, 5347 JN, The Netherlands

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

    Market
    Place

    02

    Estradiol hemihydrate

    Netherlands
    arrow
    CPhI Korea
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAspen API. More than just an API™

    Aspen API

    Registrant Name : Korea Organon Co., Ltd.

    Registration Date : 2012-11-02

    Registration Number : 20121102-181-I-30-01

    Manufacturer Name : Aspen Oss BV_x000D_

    Manufacturer Address : Veersemeer 4 5347 JN, Oss

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

    Market
    Place

    03

    Estradiol hemihydrate

    Netherlands
    arrow
    CPhI Korea
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAspen API. More than just an API™

    Aspen API

    Registrant Name : Abbott Korea Ltd.

    Registration Date : 2012-12-21

    Registration Number : 20121221-181-I-217-02

    Manufacturer Name : Aspen Oss BV

    Manufacturer Address : Veersemeer 4, 5347 JN Oss, The Netherlands

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

    Market
    Place

    04

    Estradiol hemihydrate (micronized)

    Netherlands
    arrow
    CPhI Korea
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAspen API. More than just an API™

    Aspen API

    Registrant Name : Synex Co., Ltd.

    Registration Date : 2022-01-13

    Registration Number : 20121221-181-I-217-02(A)

    Manufacturer Name : Aspen Oss BV

    Manufacturer Address : Veersemeer 4, Oss, 5347 JN, The Netherlands

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

    Market
    Place

    05

    Estradiol hemihydrate (micronized)

    Netherlands
    arrow
    CPhI Korea
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAspen API. More than just an API™

    Aspen API

    Registrant Name : Synex Co., Ltd.

    Registration Date : 2022-01-13

    Registration Number : 20220113-181-I-637-06

    Manufacturer Name : Aspen Oss BV@Aspen Oss BV

    Manufacturer Address : Kloosterstraat 6, Oss, 5349 AB, The Netherlands@Veersemeer 4, Oss, 5347 JN, The Nethe...

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

    Market
    Place

    06

    Estradiol valerate

    Netherlands
    arrow
    CPhI Korea
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAspen API. More than just an API™

    Aspen API

    Registrant Name : Synex Co., Ltd.

    Registration Date : 2022-05-26

    Registration Number : 20220526-181-I-638-07

    Manufacturer Name : Aspen Oss BV@Aspen Oss BV

    Manufacturer Address : Kloosterstraat 6, Oss, 5349 AB, The Netherlands@Veersemeer 4, Oss, 5347 JN, The Nethe...

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

    Market
    Place

    07

    Fondaparinux sodium

    Netherlands
    arrow
    CPhI Korea
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAspen API. More than just an API™

    Aspen API

    Registrant Name : Handok Co., Ltd.

    Registration Date : 2013-03-29

    Registration Number : 20130329-193-I-126-01

    Manufacturer Name : Aspen notre dame de bondeville...

    Manufacturer Address : 1, rue de l'Abbaye, 76960 Notre Dame De Bondeville@Cooppallaan 91, Wetteren, Oost-Vla...

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

    Market
    Place

    08

    Micronized progesterone

    Netherlands
    arrow
    CPhI Korea
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAspen API. More than just an API™

    Aspen API

    Registrant Name : Synex Co., Ltd.

    Registration Date : 2023-12-26

    Registration Number : 20231226-210-J-1589

    Manufacturer Name : Aspen Oss BV

    Manufacturer Address : Veersemeer 4, 5347 JN Oss, The Netherlands

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

    Market
    Place

    09

    Mirtazapine

    Netherlands
    arrow
    CPhI Korea
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAspen API. More than just an API™

    Aspen API

    Registrant Name : Synex Co., Ltd.

    Registration Date : 2022-01-12

    Registration Number : 20220112-209-J-1207

    Manufacturer Name : Aspen Oss BV

    Manufacturer Address : Veersemeer 4, 5347 JN Oss, The Netherlands

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

    Market
    Place

    10

    Remifentanil hydrochloride

    South Africa
    arrow
    AGGSpend
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Fine Chemicals Corporation PTY Ltd

    Registrant Name : Fresenius Kabi Korea Co., Ltd.

    Registration Date : 2016-08-18

    Registration Number : Su181-3-ND

    Manufacturer Name : Fine Chemicals Corporation (pt...

    Manufacturer Address : 15 Hawkins Avenue, Epping 1, Cape Town, 7460, South Africa

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

    Market
    Place

    Only 10 entries up to this point, click to access all click full view read-more
    click full view
    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    NDC API

    read-more
    read-more

    01

    ALTRENOGEST

    Netherlands
    arrow
    CPhI Korea
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAspen API. More than just an API™

    Aspen API

    NDC Package Code : 60870-0456

    Start Marketing Date : 2003-01-03

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    02

    ARBACLOFEN

    South Africa
    arrow
    AGGSpend
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Fine Chemicals Corporation PTY Ltd

    NDC Package Code : 48954-641

    Start Marketing Date : 1997-04-17

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    03

    ARGIPRESSIN

    Netherlands
    arrow
    CPhI Korea
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAspen API. More than just an API™

    Aspen API

    NDC Package Code : 60870-0277

    Start Marketing Date : 1980-04-25

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    04

    AZATHIOPRINE

    South Africa
    arrow
    AGGSpend
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Fine Chemicals Corporation PTY Ltd

    NDC Package Code : 48954-909

    Start Marketing Date : 1993-02-19

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    05

    BACLOFEN

    South Africa
    arrow
    AGGSpend
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Fine Chemicals Corporation PTY Ltd

    NDC Package Code : 48954-469

    Start Marketing Date : 1986-06-18

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    06

    BENZTROPINE MESYLATE

    South Africa
    arrow
    AGGSpend
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Fine Chemicals Corporation PTY Ltd

    NDC Package Code : 48954-448

    Start Marketing Date : 1987-04-09

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    07

    BUDESONIDE

    Netherlands
    arrow
    CPhI Korea
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAspen API. More than just an API™

    Aspen API

    NDC Package Code : 60870-0466

    Start Marketing Date : 1993-09-23

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    08

    CIDOFOVIR

    South Africa
    arrow
    AGGSpend
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Fine Chemicals Corporation PTY Ltd

    NDC Package Code : 48954-728

    Start Marketing Date : 2009-12-21

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    09

    DESMOPRESSIN

    Netherlands
    arrow
    CPhI Korea
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAspen API. More than just an API™

    Aspen API

    NDC Package Code : 60870-0440

    Start Marketing Date : 1999-07-28

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    10

    DESOGESTREL

    Netherlands
    arrow
    CPhI Korea
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAspen API. More than just an API™

    Aspen API

    NDC Package Code : 60870-0460

    Start Marketing Date : 1999-08-02

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT

    Aspen API Comapny Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    Only 10 entries up to this point, click to access all click full view read-more
    click full view

    KEY PRODUCTS

    read-more
    read-more

    TOP RANKED SUPPLIER FOR:

    Sponsored Ads.
    full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view

    Services

    Discover the service capabilities from this company

    Analytical

    Discover their expertise for : Analytical

    API Manufacturing

    Discover their expertise for : API Manufacturing

    API & Drug Product Development

    Discover their expertise for : API & Drug Product Development

    KEY SERVICES

    read-more
    read-more

    TOP RANKED SUPPLIER FOR:

    Aspen API full-view
    Small Molecule API Contract Manufacturing
    full-view
    Manufacturing of Prostaglandin Analogues
    full-view

    Excipients

    Discover the DDS // excipients from this company

    Inspections and registrations

    Check the inspections & registration from this company

    ABOUT THIS PAGE

    Contact Aspen API and get a quotation

    Aspen API is a supplier offers 87 products (APIs, Excipients or Intermediates).

    Find a price of Budesonide bulk with DMF, CEP, JDMF offered by Aspen API

    Find a price of Desogestrel bulk with DMF, CEP, JDMF offered by Aspen API

    Find a price of Estradiol bulk with DMF, CEP, JDMF offered by Aspen API

    Find a price of Estriol bulk with DMF, CEP, JDMF offered by Aspen API

    Find a price of Ethinyl Estradiol bulk with DMF, CEP, JDMF offered by Aspen API

    Find a price of Leuprolide Acetate bulk with DMF, CEP, JDMF offered by Aspen API

    Find a price of Mirtazapine bulk with DMF, CEP, JDMF offered by Aspen API

    Find a price of Norethisterone bulk with DMF, CEP, JDMF offered by Aspen API

    Find a price of Norethisterone Acetate bulk with DMF, CEP, JDMF offered by Aspen API

    Find a price of Progesterone bulk with DMF, CEP, JDMF offered by Aspen API

    Find a price of Rocuronium Bromide bulk with DMF, CEP, JDMF offered by Aspen API

    Find a price of Azathioprine bulk with DMF, CEP offered by Aspen API

    Find a price of Budesonide bulk with CEP, JDMF offered by Aspen API

    Find a price of Desmopressin Acetate bulk with DMF, CEP offered by Aspen API

    Find a price of Estradiol Valerate bulk with DMF, CEP offered by Aspen API

    Find a price of Gonadorelin Acetate bulk with DMF, CEP offered by Aspen API

    Find a price of Naloxone Hydrochloride bulk with DMF, CEP offered by Aspen API

    Find a price of Oxytocin bulk with DMF, CEP offered by Aspen API

    Find a price of Ropivacaine Hydrochloride bulk with DMF, CEP offered by Aspen API

    Find a price of Scopolamine bulk with DMF, CEP offered by Aspen API

    Find a price of Testosterone bulk with DMF, CEP offered by Aspen API

    Find a price of Baclofen bulk with DMF offered by Aspen API

    Find a price of Benztropine bulk with DMF offered by Aspen API

    Find a price of Buprenorphine Hydrochloride bulk with DMF offered by Aspen API

    Find a price of Conjugated Estrogens bulk with DMF offered by Aspen API

    Find a price of Estradiol Acetate bulk with DMF offered by Aspen API

    Find a price of Estriol bulk with CEP offered by Aspen API

    Find a price of Ethynodiol Diacetate bulk with DMF offered by Aspen API

    Find a price of Etonogestrel bulk with DMF offered by Aspen API

    Find a price of Fentanyl bulk with CEP offered by Aspen API

    Find a price of Fentanyl Citrate bulk with CEP offered by Aspen API

    Find a price of Fluphenazine bulk with DMF offered by Aspen API

    Find a price of Fluphenazine Decanoate bulk with DMF offered by Aspen API

    Find a price of Fondaparinux Sodium bulk with DMF offered by Aspen API

    Find a price of Ganirelix bulk with DMF offered by Aspen API

    Find a price of Gonadorelin Acetate bulk with DMF offered by Aspen API

    Find a price of Heparin Sodium bulk with DMF offered by Aspen API

    Find a price of Human Chorionic Gonadotropin bulk with DMF offered by Aspen API

    Find a price of Hydroxyprogesterone Caproate bulk with DMF offered by Aspen API

    Find a price of Leuprolide Acetate bulk with CEP offered by Aspen API

    Find a price of Levalbuterol Hydrochloride bulk with DMF offered by Aspen API

    Find a price of Methazolamide bulk with DMF offered by Aspen API

    Find a price of Methyl Testosterone bulk with DMF offered by Aspen API

    Find a price of Naltrexone Hydrochloride bulk with DMF offered by Aspen API

    Find a price of Nandrolone Decanoate bulk with DMF offered by Aspen API

    Find a price of Penbutolol bulk with DMF offered by Aspen API

    Find a price of Prednisolone bulk with DMF offered by Aspen API

    Find a price of Remifentanil bulk with DMF offered by Aspen API

    Find a price of Ropivacaine Hydrochloride bulk with DMF offered by Aspen API

    Find a price of Testosterone bulk with CEP offered by Aspen API

    Find a price of Testosterone Cypionate bulk with DMF offered by Aspen API

    Find a price of Testosterone Enanthate bulk with DMF offered by Aspen API

    Find a price of Testosterone Undecanoate bulk with DMF offered by Aspen API

    Find a price of Tetracosactide bulk with DMF offered by Aspen API

    Find a price of Thiothixene bulk with DMF offered by Aspen API

    Find a price of Tibolone bulk with CEP offered by Aspen API

    Find a price of Vecuronium Bromide bulk with DMF offered by Aspen API

    Find a price of Vincristine Sulfate bulk with DMF offered by Aspen API

    Find a price of Danaparoid sodium bulk offered by Aspen API

    Find a price of Eptifibatide bulk offered by Aspen API

    Find a price of Heparin Sodium bulk offered by Aspen API

    Find a price of Rimexolone bulk offered by Aspen API

    Find a price of Altrenogest bulk offered by Aspen API

    Find a price of Arginine Vasopressin bulk offered by Aspen API

    Find a price of Cidofovir bulk offered by Aspen API

    Find a price of Codeine bulk offered by Aspen API

    Find a price of Codeine Phosphate bulk offered by Aspen API

    Find a price of Conjugated Estrogens bulk offered by Aspen API

    Find a price of Dihydrotestosterone bulk offered by Aspen API

    Find a price of Estradiol bulk offered by Aspen API

    Find a price of Fentanyl Hydrochloride bulk offered by Aspen API

    Find a price of Gonadorelin bulk offered by Aspen API

    Find a price of Goserelin Acetate bulk offered by Aspen API

    Find a price of Hyoscine Butyl Bromide bulk offered by Aspen API

    Find a price of Lanreotide Acetate bulk offered by Aspen API

    Find a price of Leuprolide Acetate bulk offered by Aspen API

    Find a price of Lynestrenol bulk offered by Aspen API

    Find a price of Morphine Hydrochloride bulk offered by Aspen API

    Find a price of Morphine Sulfate bulk offered by Aspen API

    Find a price of Morphine Tartrate bulk offered by Aspen API

    Find a price of Pegcetacoplan bulk offered by Aspen API

    Find a price of Segesterone Acetate bulk offered by Aspen API

    Find a price of Sugammadex Sodium bulk offered by Aspen API

    Find a price of Testosterone Propionate bulk offered by Aspen API

    Find a price of Vinblastine Sulfate bulk offered by Aspen API

    Find a price of PREGNANT MARE SERUM GONADOTROPHIN bulk offered by Aspen API

    Find a price of SERUM, HORSE bulk offered by Aspen API

    Ask Us for Pharmaceutical Supplier and Partner
    Ask Us, Find A Supplier / Partner
    No Commissions, No Strings Attached, Get Connected for FREE

    What are you looking for?

    How can we help you?

    The request can't be empty

    Please read our Privacy Policy carefully

    You must agree to the privacy policy

    The name can't be empty
    The company can't be empty.
    The email can't be empty Please enter a valid email.
    The mobile can't be empty

    Market Place

    Market Place

    PharmaCompass

    Home

    Market Place

    Menu

    Post Enquiry

    Post Enquiry

    Market Place

    Market Place

    Search