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

Athena Acquires Medipha Santé to Expand EU Platform

03 Jun 2025

// PRESS RELEASE

Athena announces the Approval of its DDS facility

23 Sep 2024

// PRESS RELEASE

Athena Invests €10M in New Indian Pharma Manufacturing Plant

23 Sep 2024

// PRESS RELEASE

DATA COMPILATION
#PharmaFlow

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CPhI WW Frankfurt

Booth #9.2AB34

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envelop Contact Supplier

DIGITAL CONTENT

2 Interview #SpeakPharma, 3 Vlog #PharmaReel, 6 Corporate Content #SupplierSpotlight, 4 Company Bio #AboutSupplier, 1 Data Compilation #PharmaFlow, 16 News #PharmaBuzz

media
2 Interview #SpeakPharma
3 Vlog #PharmaReel
6 Corporate Content #SupplierSpotlight
4 Company Bio #AboutSupplier
1 Data Compilation #PharmaFlow
16 News #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

4 All APIs, 4 KDMF

4 All APIs
4 KDMF

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

FINISHED DOSAGE FORMULATIONS

65 FDF Dossiers, 5 FDA Orange Book, 60 Listed Dossiers

65 FDF Dossiers
5 FDA Orange Book
60 Listed Dossiers

KEY PRODUCTS

Amphotericin B, Bilastine, Bisoprolol Fumarate, Etifoxine, Fenofibrate, Josamycin, Ketoprofen, Ketorolac Trometamol, Lisdexamfetamine Dimesylate, Mesalazine, Metopimazine, Ondansetron, Paracetamol, Racecadotril, Secnidazole, Tranexamic Acid, Trazodone Hydrochloride, Zolpidem Tartrate

Amphotericin B
Bilastine
Bisoprolol Fumarate
Etifoxine
Fenofibrate
Josamycin
Ketoprofen
Ketorolac Trometamol
Lisdexamfetamine Dimesylate
Mesalazine
Metopimazine
Ondansetron
Paracetamol
Racecadotril
Secnidazole
Tranexamic Acid
Trazodone Hydrochloride
Zolpidem Tartrate

SERVICES

Packaging, Drug Product Manufacturing, API & Drug Product Development

pharmaServices
Packaging
- 1 Contract Services
Drug Product Manufacturing
API & Drug Product Development
- 1 Preformulation & Material Science
- 6 Formulation Development

KEY SERVICES

ODT Development & Manufacturing, Taste Masking, Pediatric Formulation Development

ODT Development & Manufacturing
Taste Masking
Pediatric Formulation Development

INSPECTIONS & REGISTRATIONS

8 EDQM, 1 WHO-GMP

inspections
8 EDQM
1 WHO-GMP

Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.

About

Athena Pharmaceutiques is a France-based company dedicated to developing new value-added products with a broad range of technology platforms. Athena has over 400 employees in factories and R&D centers in France and India. Athena has developed a wide range of products in various therapeutic segments like pain, CNS, cardiovascular, gynaecology, gastroenterology, etc. Athena’s specialties include oral dispersible tablets (ODTs), customized drug release, corticosteroids, effervescent tablets and fixed dose combinations. Athena is your go-to partner for licensing differentiated branded generics.

CPhI KoreaCPhI Korea

Industry Trade Show

Not Confirmed

26-28 August, 2025

COEX, Seoul, Korea
CPhI WW FrankfurtCPhI WW Frankfurt

Industry Trade Show

Booth #9.2AB34

28-30 October, 2025

Frankfurt
KY/TN Water Profession...KY/TN Water Professionals

Industry Trade Show

Not Confirmed

27-30 July, 2025

Knoxville, TN

CONTACT DETAILS

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Country

France

Address

Bat D 6e étage Bureaux de la colline 92210 St Cloud

Telephone

+33 327434500

contact@ddsathena.com

Website

https://athenapharmaceutiques.com/

https://www.linkedin.com/company/athena-drug-delivery-solutions-pvt-ltd/

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Digital content

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INTERVIEW #SpeakPharma

“Athena’s R&D prowess is its key differentiator, with our India unit bringing in excellent knowledge”

This week, SpeakPharma interviews Alexandre Williams, owner and director of Athena Pharmaceutiques, which is a trusted partner of choice to source differentiated branded generics in the pharmaceutical sector. Williams discusses the importance of research and development (R&D) to deliver cutting edge medical solutions to the international market, and the strategy behind choosing India to expand its R&D operations. 🔑 HIGHLIGHTS// branded generics/ innovation/ forward thinking/ CDMO/ France/ India Athena Pharma has come a long way since it was first spun off from its parent company — Ethypharm — in 2011. The growth has been particularly remarkable over the last three years. Tell us how the company has managed to scale new heights during and post the Covid-19 pandemic? We’ve been expanding operations in emerging markets since 2012, while also not ignoring developed markets. In 2017, we launched products in Europe, Canada, and the UK among other markets. So, we’ve been on a roll. Covid had, in fact, a small impact on our activity. It did slow down some R&D and expansion projects. However, given our broad portfolio with allergy, anti-emetic and pain relief products, we saw an increase in sales during the pandemic. In fact, 2020 was a big year for us. We acquired our first European factory in France — Athena IPS, set up our first office in Canada, and bought an effervescent technology. In 2022, we acquired the brand Secnol (secnidazole) and launched a new R&D facility in India. Compared to Covid, we saw the European energy inflation crisis as a bigger threat, given the continent’s reliance on Russia for energy. Russia’s invasion of Ukraine and the expected sanctions on Russian imports meant that energy costs were going to skyrocket and create a massive turmoil in the supply chain. Those repercussions were felt by the market and our clients. Our growth is fueled by our extensive portfolio of products. We have a huge number of launches planned in Brazil and pretty much every emerging market. Indeed, we will see over 100 new launches in the next two years. 🔑 HIGHLIGHTS// EU/ UK/ factory in France/ new office in Canada/ new R&D unit in India/ effervescent tech/Secnol acquisition How is the market for branded generics growing? How is Athena creating a differentiation within this market to prolong the life of well-established products through improved drug delivery systems? As mentioned, the pandemic was a booster for the branded generics market. As healthcare systems the world over scrambled to meet needs, accessibility and affordability that come with branded generics made them even more crucial. Furthermore, global supply chain disruptions led to a shift toward manufacturing locally and regionally produced branded generics. India has emerged as the largest generic supplier in the world. And with its growing population, the demand for affordable medication has also grown. Branded generics are best supported with improved formulations. By offering a better, different or new product, our partners can market differentiated products that are set apart from competition. The differentiation must really bring an improvement in terms of delivery, compliance, taste or dosing. Only real lifecycle advantages make a difference, but it also must be cost effective to allow our partners to push sales of these new brand generics. 🔑 HIGHLIGHTS// pandemic boosted branded generics market/ India emerged as largest generic supplier How important has R&D been to the company’s objective of delivering cutting-edge drugs? What steps have to be undertaken to ensure Athena’s commitment and dedication to R&D? Innovation has always been central to Athena’s DNA, right from our humble beginnings. The mission was to leverage great research and development (R&D) to deliver cutting edge medical solutions to the international market. We have invested steadily since our inception, including an investment in 2021 that led to opening up of our French R&D center. A year later, our new R&D center came up in Mumbai, adjacent to our Indian factory. Personnel is key and I must say that I am highly proud of our R&D team. Building a good team takes time and effort. No R&D department can function without the right people. 🔑 HIGHLIGHTS// innovation/ team work/ right people Athena has expanded its global presence (in markets like Brazil, Canada and China) in recent years. How have these expansions contributed to growth? Different geographies come with different situations, needs, demographies, and healthcare challenges. This forces us to adapt our technology to create products of interest in each of those territories. When we successfully pull off a product lifecycle in one market, we can take what we learned and make that product a huge success in other markets. For instance, in Canada we developed a generic zolpidem tablet for insomnia that disintegrates under the tongue. We then adapted it and positioned it as branded generic for Latin America and Europe and saw great success. 🔑 HIGHLIGHTS// different geographies — different needs How have dosage forms like oro-dispersible and modified release formulations performed? Have you added more drugs to these dosage forms? Oro-dispersible tablets (ODTs) are like conventional tablets with super disintegrants that dissolve in the mouth within minutes. ODTs have made it easy to administer medication, especially in pediatric, geriatric, and mental illness populations. This makes them a very popular dosage form. Improved patient compliance, rapid onset of action, and improved stability are some of the advantages we’ve seen. Athena’s Fastmelt technology has rendered it a leader in the ODT space. Modified drug release protracts the drug’s release into the bloodstream or to a specific target and this means they can be taken at less frequent intervals. We’ve seen an increase in patient convenience, compliance, and thereby improved efficacy. Sustained release (SR) products sustain the level of a drug in the bloodstream and reduce adverse effects. Indeed, we had developed many ODTs, taste masked and SR products. But what amazes me is that every time you are afraid that those matured technologies will become outdated, they don’t, and we have endless new developments to be carried out. 🔑 HIGHLIGHTS// ODTs for pediatric, geriatric, and mental illness/ SR drugs sustain level in bloodstream, reduce side effects What are some of the fastest growing drug release mechanisms? How is effervescent technology performing? As I mentioned, we are seeing speedy growth in drug delivery technologies. Fixed dose combinations are products of two or more drugs in a single dose. The simpler dosing schedule leads to excellent patient compliance, and it is among the fastest growing drug release mechanisms. Effervescent technology is widely used in Europe, and worldwide it is used to deliver vitamins. The technology is of particular interest when it comes to products that need to be solubilized and drugs that absolutely need to be taken with water. However, effervescent technology is underdeveloped in emerging markets and only used for over-the-counter (OTC) or food supplement products. There are many new formulations that can use effervescent technology, so we can easily expand. 🔑 HIGHLIGHTS// effervescent tech for vitamins/ yet to pick up in emerging markets What are some growth plans of Athena? Where do you see the company in the next five years? Our new target markets for the coming years are China and the US, where we aren’t as active at present. As far as growth goes, the most critical aspect is identifying the product that is to be developed. So, our goal in the coming years is to enrich our portfolio of products that bring real value to people and their quality of life. Ideas are welcome! 🔑 HIGHLIGHTS// China/ USA/ expand portfolio In terms of drug delivery technologies, Athena has come up with some groundbreaking solutions. Could you please tell us how these may be game-changers in the lives of patients? These days, there is a lot of talk about revolutionary biotechnologies like ARNm (advances in radiotherapy and nuclear medicine) and CAR-T therapies, which specifically target and eliminate cancer cells more effectively. But we should not underestimate the crucial role our drug delivery technologies play, particularly in enhancing medication acceptance and compliance. They hold immense potential and remain an integral part of the healthcare landscape because we offer cost-effective and impactful solutions that improve patient outcomes. 🔑 HIGHLIGHTS// enhancing medication acceptance and compliance/ cost-effective and impactful solutions Can artificial intelligence (AI) and machine learning help in discovering new drug delivery technologies? If so, then how? They can certainly help in pharmacodynamics (effects of drugs and the mechanism of their action). In the in vivo vitro correlation, which is the predictive mathematical model that describes the relationship between the in vitro property of an oral dosage form and the corresponding in vivo response, Al can help gain a better understanding of the drug’s release or dissolution and the amount absorbed. AI can help optimize and perhaps even individualize timing and dosage. It can analyze patient data, health records, geographical locations, medical literature, and patient demographics to match patients for clinical trials and monitor the trials for adverse events. Such real-time analysis can increase patient safety and help researchers assess how individual patients respond. It can help design formulations and select which technology serves the patient best. The use of AI will be massive, and we are just starting to use it. 🔑 HIGHLIGHTS// pharmacodynamics/ optimize and perhaps even individualize timing and dosage/ patient safety What were the factors that helped Athena choose India for its expansion, particularly for R&D? R&D power is really what makes Athena different, and it is thanks to our Indian staff who are experienced and well trained in pharmaceutical development. So, we chose India mainly for excellence in drug delivery and knowledge of pharmaceutical development. And not just for cost-effectiveness. The Indian skill and competence are enhanced by the fact that Athena is active in so many markets from Europe and Canada to Brazil, Russia, and Asia. So, competence and experience required in those pharmaceutical markets is being acquired by our Indian personnel. The country is also doing a lot to ease foreign entry into its pharmaceutical industry like reducing timelines for facility approval. 🔑 HIGHLIGHTS// India: Excellence in pharma knowledge for DDS development

Impressions: 2619

VLOG #PharmaReel

Your Trusted Partner in Pharmaceutical Development

Athena Pharmaceutiques, a French-based company, specializes in developing differentiated branded generics and OSDs to enhance patient compliance and well-being, positioning itself as the partner of choice for pharmaceutical companies for life-cycle management.

Impressions: 409

CORPORATE CONTENT #SupplierSpotlight

Secnidazole Product Overview 2025

Product List 2025

Corporate Presentation

GMP Certificate 2025

India Pharmaceuticals 2017

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Pharmaboardroom Interview Alexandre Williams

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DATA COMPILATION #PharmaFlow

CDMO Activity Tracker: Veranova, Carbogen lead ADC investments; Axplora, Polfa Tarchomin, Famar expand European footprint

During the second quarter (Q2) of 2025, contract development and manufacturing organizations (CDMOs) made substantial investments in specialized therapeutic manufacturing. The quarter also saw CDMOs pursue high-value, complex manufacturing niches, particularly in antibody-drug conjugates (ADCs), cell and gene therapies (CGTs) and oligonucleotides.Alongside these trends, Q2 also saw CDMOs strengthen their footprint in the United States amid concerns over rising tariffs and unpredictable trade policies being enforced by the Trump administration.Regeneron Pharmaceuticals committed over US$ 3 billion through a 10-year agreement with Fujifilm Diosynth Biotechnologies to nearly double its US manufacturing capacity for biologics. Under this agreement, Fujifilm will manufacture and supply drug products for Regeneron at its large-scale facility in Holly Springs, North Carolina.Thermo Fisher Scientific announced plans to invest an additional US$ 2 billion in the US over four years, reinforcing its manufacturing and R&D capabilities. With 64 facilities spread across 37 states, Thermo Fisher aims to bolster American innovation and competitiveness. Similarly, Piramal Pharma announced a US$ 90 million investment plan for expanding two facilities in the US, thereby bringing its total investment in the country to US$ 570 million. View CDMO Activity Tracker for Q2 2025 (Free Excel Available)Veranova, Carbogen lead ADC wave; Axplora doubles down on HPAPI production in ItalyThe quarter saw substantial investments in ADC manufacturing. Veranova announced a US$ 20 million investment in bioconjugation development and cGMP manufacturing capacity at its Devens, Massachusetts campus. With this investment, Veranova will be able to provide a more comprehensive suite of services to its partners developing ADCs and other bioconjugates. Veranova’s total investment in the Devens facility now stands at over US$ 50 million. Swiss CDMO Carbogen announced a US$ 31 million co-investment with an unnamed Japanese investor to expand its capabilities across its Aarau and Neuland (Switzerland) facilities. The facility will address increasing demand for complex and high-value compounds such as ADC drug linkers.Axplora announced a further €35 million (US$ 41 million) expansion of its Farmabios site in Italy, doubling the facility to approximately 108,000 square meters by mid-2026. This investment raises its total spend on the site to over €80 million (US$ 94.05 million) since 2019, supporting the production of highly potent active pharmaceutical ingredients (HPAPIs). Farmabios now stands as a key hub in Axplora’s global CDMO network.Polish pharmaceutical manufacturer Polfa Tarchomin is positioning itself as a significant player in the European CDMO market through its investment in the Center for Development and Production of Highly Potent Drugs. This 12,000 square meter facility has two state-of-the-art production lines designed for filling vials and pre-filled syringes with an annual capacity of 26 million product units.Skyepharma’s projected annual revenues from oncology-linked activities touched €10 million (US$ 11.2 million). The CDMO’s facility in Saint-Quentin-Fallavier is equipped to handle cytotoxic and cytostatic compounds, and is one of the few facilities in France capable of managing HPAPIs for oral anticancer treatments. View CDMO Activity Tracker for Q2 2025 (Free Excel Available) Athena acquires Medipha Santé, Famar buys MiP Pharma’s German site to strengthen European footprintDuring the quarter, several CDMOs enhanced their strategic capabilities through M&As. Athena Pharmaceutiques acquired Medipha Santé to build a fully integrated pharmaceutical services platform in Europe. Based in Paris, Athena has strengthened its commercial and regulatory toolbox by bringing aboard Medipha Santé’s 35-strong team, which supports over 100 partner organizations and files approximately 350 dossiers annually with ANSM and other European agencies. With this integration, Athena positions itself as a one-stop CDMO partner.With the acquisition of MiP Pharma’s sterile manufacturing site in Homburg, Germany, the Famar Group has expanded its capabilities in aseptic and lyophilized fill-and-finish operations. The acquisition has strengthened Famar’s position in sterile drug manufacturing. The CDMO now has seven manufacturing facilities in Europe.PCI Pharma Services’ acquisition of Ajinomoto Althea has established a world-class, large-scale manufacturing hub in the San Diego region with state-of-the-art aseptic facilities for prefilled syringes, cartridges and high-potent formulations such as ADCs. PCI Pharma is now amongst the few US-based CDMOs capable of comprehensive ADC manufacturing.Samsung Biologics’ strategic spinoff of its biosimilar business stood out as a significant corporate restructuring exercise during the quarter. The separation of Samsung Bioepis, tentatively renamed Samsung Epis Holdings, aims to enhance Samsung Biologics’ strategic focus and build client trust, as it eliminates potential conflicts between CDMO services and proprietary drug development. The move came after Samsung Biologics inked a contract worth 737.3 billion Korean won (US$ 518 million) with an undisclosed US pharmaceutical company.WuXi Biologics announced a US$ 167 million divestment of its German facility to Terumo and broke ground on a microbial production plant in China. National Resilience, which was launched five years ago as the US drug manufacturer dedicated to broadening access to medicines and protecting biopharma supply chains, said it is shuttering six of its 10 facilities. The company said the sites were “not being fully utilized.” View CDMO Activity Tracker for Q2 2025 (Free Excel Available) MilliporeSigma, Simtra form 5-year ADC alliance; Silexion partners Catalent for siRNA developmentMerck KGaA’s MilliporeSigma and Simtra struck a five-year strategic alliance, combining expertise across the ADC value chain to reduce development timelines and complexity for biopharmaceutical companies. Viralgen collaborated with Trogenix to rapidly scale product supply for TGX-007, an AAV gene therapy for glioblastoma (a type of cancer of the brain and spinal cord). Silexion announced a collaboration with Catalent for small interfacing RNA (siRNA) development and manufacturing. Catalent’s Limoges (France) facility will conduct formulation development and clinical manufacturing for Silexion’s SIL204 candidate, supporting both systemic and intra-tumoral delivery formulations.Skyepharma’s collaboration with Eneapharm through the Skyehub platform aims to support the treatment of patients suffering from exocrine pancreatic insufficiency, including those affected by cystic fibrosis or pancreatic cancer. Orion Corporation reached an agreement with Shilpa Biocare for the distribution of recombinant human albumin in Europe.Meanwhile, Aenova announced the launch of its Aenovation program, an initiative designed to fast-track early development of pharmaceutical formulations. The program addresses the critical challenges of bioavailability and time-to-market faced by poorly soluble drug candidates. View CDMO Activity Tracker for Q2 2025 (Free Excel Available) Our view The quarter saw CDMO developments mimic the broader trends in the pharmaceutical industry, such as onshoring of critical manufacturing capabilities in the US, consolidation of specialized expertise through strategic partnerships, and the relentless focus on emerging therapeutic modalities that promise to transform patient care. With CDMOs continuing to invest in next-generation manufacturing capabilities, we expect the sector to play a crucial role in drug innovation.

Impressions: 3918

COMPANY BIO #AboutSupplier

Overview of oral solid dosage forms (OSD) like orodispersible tablets (ODTs) & more on Athena's CDMO services for oral drug delivery on PharmaCompass.

Overview of oral solid dosage forms (OSD) like orodispersible tablets (ODTs) & more on Athena's CDMO services for oral drug delivery on PharmaCompass. Q1. What is oral drug delivery? Oral drug delivery (ODD) is the most preferred and convenient route of drug administration due to high patient compliance, cost-effectiveness, low sterility constraints, flexibility in the design of user-friendly dosage forms, innovative unit-dose solutions, and ease of production. Oral formulations are introduced into the body by several routes of administration including oral and buccal, amongst various others. Many drugs can be administered orally as liquids, capsules, tablets, effervescent tablets, oral sticks, chewable tablets, etc. Drugs administered orally (e.g., tablets, capsules,, solutions, oral suspensions, etc.) are placed in the mouth and swallowed. Although a few drugs taken orally are intended to be dissolved in the mouth such as Orally Disintegrating Tablets (ODTs). The oral route is by far the most common route of drug administration in the gastrointestinal tract and can be used for both systemic drug delivery and for treating local gastrointestinal diseases. Formulations can also be designed to enhance pharmaceutical drug delivery to specific regions in the upper or lower gastrointestinal tract. As seen above, oral drug delivery is facilitated by oral formulations including solid dosage products and liquid oral forms. Oral solids include tablets, oral films, chewable capsules, chewable tablets, powders, granules, enteric coated solids, sticks, orally disintegrating tablets (ODT), etc. User-friendly dosage forms and innovative unit-dose solutions including tablets and capsules have a high degree of drug stability and provide accurate dosage, and are therefore preferred. On the other hand, liquid oral forms include oral suspensions, syrups, elixirs, spirits, drops, etc. Out of these liquids, oral suspensions and solutions are the most widely used liquid oral forms. Various pharmaceutical organizations offer specialized services and formulations which facilitate oral drug delivery such as Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (ie. pharmaceutical CDMO for oral drug delivery). Some Advantages of Oral Drug Delivery - Safe, good patient compliance, ease of ingestion, and pain avoidance. - Versatility to accommodate various types of drugs. - Cheap and economical formulations. - User-friendly dosage forms and innovative unit-dose solutions. - Patients can self-administer oral formulations and oral films. - No sterile precautions are needed and danger of acute drug reactions is minimal. Q2. What are the different types of solid oral dosage forms? Solid oral forms or oral solid dosage (OSD) forms refer to a final drug product therapy that is ingested through the mouth, dissolved in the digestive system, and delivered to the body through absorption into the bloodstream. Tablets, capsules, soft gels, effervescent formulations (effervescent tablets), oral films, lozenges, oral disintegrating tablets (ODT) and pills, are all oral solid dosage products. They are relatively easy to administer and it’s easy to distinguish one OSD product from another. Furthermore, OSD commercial and clinical manufacturing methods are well understood and well-developed. Some Types of Solid Oral Dosage Forms or Solid Oral Forms - Tablets The oral route of drug administration is the most convenient for patients, with tablets emerging as the most popular solid oral dosage forms used today. Tablets are solid dosage products containing one or more active pharmaceutical ingredients (APIs) and functional excipients. They are usually circular in shape and may be flat or convex. These unit dosage forms are accurate, stable and offer great precision and low variability. Furthermore, tablets are the cheapest oral dosage form, easy to handle and use, and have an attractive and elegant appearance. Tablets ingested orally include compressed tablets, press coated tablets, multilayer tablets, sustained action tablets, enteric located tablets, sugar coated tablets, oral disintegrating tablets (ODT), film coated tablets and chewable tablets, while tablets used in the oral cavity include buccal tablets, sublingual tablets, lozenges, and dental cones. Standard compressed, controlled-release and coated tablets are the most common form of solid oral forms or oral formulations for pharmaceutical drug delivery to the gastrointestinal tract. - Capsules Capsules are common dosage forms for oral administration of pharmaceutical and nutraceutical products. They are produced in various shapes, sizes and materials, and each capsule generally contains a single dose of active pharmaceutical ingredients (APIs). In addition to the active pharmaceutical ingredient (API), other functional excipients are incorporated into the fill material, including antimicrobial preservatives, fillers, flavouring agents, sweeteners and colouring agents. Capsules are available in the form of hard gelatin capsules, soft gelatin capsules, modified release capsules and enteric coated capsules. Capsule oral solid dosage forms (OSD) are smooth and easy to swallow, easy to handle and carry, economically feasible, therapeutically inert, attractive in appearance, and can be taste-masked, amongst various other benefits which make them a popular pharmaceutical dosage form. - Powder A powder is a mixture of finely divided drugs and/or chemicals in dry form including active pharmaceutical ingredients (APIs) and inert functional excipients. Powders can be used internally and externally (e.g., external applications to the skin). Dry powders, however, can be taken orally by some patients who are unable to swallow other solid dosage forms such as capsules and tablets. The onset of action of powders is rapid as compared to tablets and capsules, small children and elderly patients can take powdered drugs as is or dissolved in water easily, and it is more economical as compared to other solid dosage forms because it doesn’t require any special machinery or technique. Q3. Why is outsourcing key to bringing flexibility and capacity to oral solid dosage form manufacturing? The trend towards outsourcing oral solid dose commercial and clinical manufacturing has been driven by the ever more complex nature of new molecules. Innovators are choosing to share the burden of challenges relating to bioavailability, formulation, stability, manufacturability and most importantly, scalability (commercial capabilities; scale-up and full commercial manufacturing). Industry pressures to reduce pharmaceutical development times and costs, as well as increasing numbers of smaller drug developers now taking products to market independently, are spurring partnerships with contract development and manufacturing organizations (specialist CDMOs) who can bring formulation development and manufacturing expertise, global experience and broad service offerings. A contract development and manufacturing organization (CDMO) is a company within the pharmaceutical industry that provides CDMO services ranging from drug product pharmaceutical development and manufacturing to pharmaceutical packaging. Companies partner with pharmaceutical CDMOs as a way to outsource drug development and manufacturing services to third-parties. Working with a contract development and manufacturing organization (CDMO) allows drug companies to benefit from a long-term partnership with an experienced team offering operational excellence, specific scientific skills, equipment and technical resources that are not available internally, resulting in a robust supply chain, reduced risks and optimized costs. A CDMO for oral drug delivery offers various CDMO services such as oral solid dose (OSD) formulation development, drug development and manufacturing services (cGMP manufacturing), oral drug delivery technologies, clinical manufacturing, scale-up and full commercial manufacturing (commercial capabilities), etc. Outsourcing is Key to Bringing Flexibility and Capacity to Oral Solid Dosage Form Manufacturing: - Flexibility Outsourcing oral solid dosage form manufacturing to experienced contract manufacturers gives partnering companies access to cutting edge pharmaceutical drug delivery technology on a need basis, thereby giving the organization flexibility. This is important as owning novel oral drug delivery technologies can be very costly. - Capacity Outsourcing the production of oral solid dose (OSD) forms reduces excess production capacity by divesting facilities and minimizes investments in capital intensive facilities. An oral drug delivery CDMO can make strategies to lower company expenses by reducing fixed costs and modifying its capacities. Q4. What are the trends and challenges in oral solid dosage outsourcing? Some Trends In Oral Solid Dosage Outsourcing - The overriding trend is continued oral solid dosage outsourcing, by big pharmaceutical organizations due to divesting commercial and clinical trial manufacturing and small-to-mid-sized companies that do not have commercial capabilities and clinical trial manufacturing capacities. - The requirement for more complex oral solid cGMP manufacturing processes is leaving many developers struggling to find the right technical set-up that is manageable from a cost standpoint. Outsourcing to a pharmaceutical CDMO for oral drug delivery that can offer a broad range of specialist CDMO services such as scale-up and full commercial manufacturing help simplify supply chains. - As drug companies have fewer and fewer new compounds entering their R&D pipelines, outsourcing of development and commercial activities along with clinical trial manufacturing for oral solid dosage forms (OSD) and sterile forms is on the rise. - Companies find outsourcing easier in recent times due to technological advancements, knowledge sharing platforms, and increasing convergence between various government regulatory authorities. - Working with a specialist CDMO for oral drug delivery minimizes the need for in-house resources. Drug developers can take advantage of specialized oral drug delivery technologies for the manufacture of controlled release products, as well as the capability to produce combination products with several APIs. The above mentioned factors are expected to drive the global oral solid dosage contract manufacturing market in the near future. Some Challenges In Oral Solid Dosage Outsourcing - In-house production of oral solid dosage forms (OSD) provide companies ultimate control over the quality and the quantity of products. Also, the company can easily change scope, adjust timelines and increase or decrease the volume of oral solids based on the market demand. Outsourcing production of oral solids hands this power over to the CDMO facility. - Contract manufacturing organizations (CMOs) may fail to deliver supplies of the oral solid dose (OSD) on time as per the requirement. There is also a reduction in in-house cGMP manufacturing expertise in terms of resources and process knowledge for manufacturing oral solids. Furthermore, there could be a risk of non-compliance of regulatory requirements by a CMO or CDMO for oral solids. - In outsourcing, customers give up all decision making to the contracted company. If the wrong innovative CDMO for oral solids is chosen which doesn’t match their partners’ needs, it could lead to a bad customer experience. Furthermore, differences in standards of specialized services could lead to quality problems. Carefully selecting a CMO or CDMO for oral solids can help avoid the above given challenges associated with oral solid dose (OSD) outsourcing. A logical first step in selecting a CMO (contract manufacturing organization) or a CDMO (contract development and manufacturing organization) involves making an assessment of internal capabilities, strengths, and needs that can then be overlaid on anticipated external requirements. Following which, the criterions for selecting a compatible CMO or CDMO for oral solids are divided into two broad categories, namely culture and quality Q5. What oral drug delivery services does Athena offer? Athena with its EU GMP approved facility and state-of-art R&D centre is focused on innovative and value-added products in mature and emerging markets and engages in licensing and pharmaceutical development models for specialty pharma, multinationals, and other established companies. Athena’s specialities include Oral Dispersible Tablets (ODTs), Customized Drug Release, and Fixed Dose Combinations. Athena provides comprehensive formulation development, contract manufacturing (cGMP manufacturing), and product lifecycle management solutions for oral solids, multi-particulate systems, effervescent formulations (effervescent tablets), sticks etc. based on its proprietary drug delivery technology platforms. Athena, which functions as an oral drug delivery CDMO offering drug development and manufacturing specialized services, has developed a broad range of drug delivery technology platforms for oral delivery with a special focus on modified release formulations as well as orodispersible dosage forms. The innovation team at Athena has been developing products at different stages for various MNC clients and is equipped to handle complex products and technologies for both advanced and emerging markets. Athena has a broad range of drug delivery platforms. All these platforms are for oral drug delivery and are validated. - Orally Disintegrating Tablets (ODT) - Customized Drug Release (SR; EC; Zero order; Sublingual) - Extended release technology - Multi-particulate systems via its multi-particulate control release technology - Fixed Dose Combination (FDC)

Impressions: 1242

NEWS #PharmaBuzz