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

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

07 Mar 2024

// PRESS RELEASE

Gold Medal for Aspen API in EcoVadis Evaluation

31 Oct 2023

// PRESS RELEASE

Fine Chemicals Corporation facility in Cape Town, South Africa was inspected by the PMDA.

31 Oct 2023

// PRESS RELEASE

DATA COMPILATION
#PharmaFlow

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Website

CPhI India 2024

Attending

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envelop Contact Supplier

DIGITAL CONTENT

7 CORPORATE CONTENT #SupplierSpotlight, 3 COMPANY BIO #AboutSupplier, 1 DATA COMPILATION #PharmaFlow, 89 NEWS #PharmaBuzz

media
7 CORPORATE CONTENT #SupplierSpotlight
3 COMPANY BIO #AboutSupplier
1 DATA COMPILATION #PharmaFlow
89 NEWS #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

120 All APIs, 60 USDMF, 32 CEP/COS, 16 JDMF, 15 KDMF, 62 NDC API, 4 VMF, 90 Listed APIs

120 All APIs
60 USDMF
32 CEP/COS
16 JDMF
15 KDMF
62 NDC API
4 VMF
90 Listed APIs

DEVELOPMENTS

10 Drugs in Development

10 Drugs in Development

FINISHED DOSAGE FORMULATIONS

1867 FDF Dossiers, 35 FDA Orange Book, 113 Europe, 61 Canada, 315 Australia, 1342 South Africa, 1 Listed Dossiers

1867 FDF Dossiers
35 FDA Orange Book
113 Europe
61 Canada
315 Australia
1342 South Africa
1 Listed Dossiers

KEY PRODUCTS

Azathioprine, Desogestrel, Dihydrotestosterone, Estriol, Etonogestrel, Fentanyl, Fentanyl Citrate, Fentanyl Hydrochloride, Ganirelix, Goserelin Acetate, Lanreotide Acetate, Oxytocin, Segesterone Acetate, Testosterone, Testosterone Cypionate, Testosterone Enanthate, Testosterone Propionate, Testosterone Undecanoate

Azathioprine
Desogestrel
Dihydrotestosterone
Estriol
Etonogestrel
Fentanyl
Fentanyl Citrate
Fentanyl Hydrochloride
Ganirelix
Goserelin Acetate
Lanreotide Acetate
Oxytocin
Segesterone Acetate
Testosterone
Testosterone Cypionate
Testosterone Enanthate
Testosterone Propionate
Testosterone Undecanoate

SERVICES

Analytical, API Manufacturing, API & Drug Product Development

pharmaServices
Analytical
- 1 Analytical Method Development
API Manufacturing
API & Drug Product Development
- 8 API Development

KEY SERVICES

Contract Manufacturing for Steroid APIs, CDMO for Small Molecules

Contract Manufacturing for Steroid APIs
CDMO for Small Molecules

EXCIPIENTS

1 All Excipients, 1 USDMF

excipientPortfolio
1 All Excipients
1 USDMF

INSPECTIONS & REGISTRATIONS

25 FDA, 30 EDQM, 6 GDUFA

inspections
25 FDA
30 EDQM
6 GDUFA

Aspen API. More than just an API.

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.

CPhI India 2024CPhI India 2024

Industry Trade Show

Attending

26-28 November, 2024

India Expo Centre, Greater Noida
Pharmtech & Ingredient...Pharmtech & Ingredients

Industry Trade Show

Not Confirmed

19-22 November, 2024

Crocus Expo, Pavilion 2, Moscow
Rescon USA SummitRescon USA Summit

Industry Trade Show

Not Confirmed

21-22 November, 2024

Manhattan, New York

CONTACT DETAILS

Click the arrow to open the dropdown

Country

Netherlands

Address

Kloosterstraat 6, 5349 AB Oss

Telephone

+31 882779000

api@nl.aspenpharma.com

Website

https://www.aspenapi.com/

https://www.linkedin.com/company/aspen-api/

YouTube

https://www.youtube.com/@aspenapi

Digital content

Explore the latest content creation from this company

CORPORATE CONTENT #SupplierSpotlight

Product List 2023

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Corporate Presentation

GMP Certificate 2023

Green Answer to Peptide Synthesis

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Your Personal API Partner

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Green Continuous Liquid Phase Peptide Synthesis (GC-LPPS)

Sustainable APIs Manufacturing 2022

DATA COMPILATION #PharmaFlow

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.

Impressions: 2856

COMPANY BIO #AboutSupplier

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: A manufacturer of HPAPIs should consider several areas in order to safely manage high potency active pharmaceutical ingredient (HPAPI) processes. For successful HPAPI (highly potent API) development, extensive knowledge and experienced staff are required. Relevant training should be provided to the staff. The training should also feature in-depth information on every step of the handling process, equipment use and unit operations. Employee exposure to high potent active pharmaceutical ingredients (HPAPIs) is typically the primary concern for manufacturers. As such, it is essential to put a thorough cleaning program in place to avoid contaminating surfaces. If an undesired event occurs, manufacturers of highly potent intermediates and active pharmaceutical ingredients should have a response plan to work from, indicating appropriate reaction from employees to an unplanned incident. Highly potent active pharmaceutical ingredients (HPAPIs) have a specific occupational exposure limit (OEL) that must be kept in mind to ensure safe handling, as there is a selective process in choosing the most appropriate containment strategy. An occupational physician should work closely with the committee, regulatory authorities and any relevant health and safety bodies. Inadequate containment of high potent API (HPAPI) can decrease product yields or cause cross-contamination of the final product. 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 dispensing Integration 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: 1738

NEWS #PharmaBuzz