By PharmaCompass

2021-10-11Impressions: 805

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View Athena's portfolio of products for oral drug delivery including Oral Dispersible Tablets (ODTs) & browse Athena's CDMO services on PharmaCompass.

Q1. What is Athena and what CDMO services does it offer?

Athena Pharmaceutiques SAS is a pharmaceutical company, CDMO focused on the development, manufacturing, and licensing of value-added products. With its EU GMP approved facility and state of art R&D centre, Athena is focused on innovative and value-added products in mature and emerging markets and is engaged in licensing and development models for specialty pharma, multinationals and other established companies. 

Athena aspires to be a global leader in pharma, innovation and drug delivery and to be a partner of choice for multinational pharmaceutical companies for their life cycle management requirements, with a mission to enhance value to patients and improve patient compliance. 

CDMO Services Offered by Athena Pharmaceutiques SAS:

- Oral Dispersible Tablets / ODTs 

Athena is a leader in oral dispersible tablet manufacturing or ODT contract manufacturing and development, based upon its platform technologies. Using its Fastmelt® platform, the company today commercially sells at least 10 products in various markets. 

Athena develops and commercializes its partners products such as effervescent formulations on this platform technology, which address a clients' product life cycle management needs and bring added value to their portfolio.

Its Oral Dispersible Tablet (ODT) platform for oral dispersible tablet manufacturing or ODT contract manufacturing has unique propositions for:

- Paediatric patients - Geriatric patients - All patients with dysphagia - All patients with fear of swallowing - Psychiatric patients

Taste Masking

Taste masking is a very critical ingredient for oral dispersible tablet manufacturing or ODT contract manufacturing. Today there are close to 200 drugs on the market which have obnoxious taste and thereby become a deterrence in patient compliance. Athena uses specialized techniques for taste masking the bitter or pungent tastes of drugs using encapsulation technology.

- Customized Drug Release

Given its vast experience in drug delivery, Athena has developed several products with client specific or customized drug release profiles using its customized drug release pelletization technology, a multi-particulate coating technology specialized platform for developing spheroidal particles. 

- Fixed Dose Combinations (FDCs)

Athena has developed Fixed Dose Combination (FDC) formulations for multiple active ingredients combined in a single dose. Further, Athena has added value to FDCs by using relevant technology platforms to increase patient compliance. Fixed Dose Combination (FDC) drug products are known to improve compliance by reducing the pill burden on patients, as well as giving inherent advantages of combination therapy.

Advantages of Fixed Dose Combinations (FDCs)

- Simpler dosage schedule - Increased patient compliance - Reduction of inadvertent medication errors - Synergistic effects on dosage regimen - Reduced side effects 

Q2. What are some of Athena's product offerings?

Athena Pharmaceutiques SAS' vision is to become a world-class drug delivery trade partner for pharma laboratories globally. Athena sells both semi-finished bulk and finished formulations in stick packs across many markets in the world. 

Besides India, where Athena has partnered with many multinational and Indian companies for selling finished boxes, it also exports both finished formulations and semi-finished products like pellets, to be filled in capsules and granules ready for compression, to several key clients in almost 20 countries.

Athena has been dedicated to developing lifecycle products and has developed a broad range of technology platforms for oral drug delivery with a special focus on modified release formulations as well as orodispersible dosage forms. 

Using these technologies Athena develops a wide range of products (e.g. effervescent formulations) in various therapeutic segments like pain, CNS, cardiovascular, diabetes, gastroenterology, etc.

Some Pharmaceutical Formulations Offered by Athena Pharmaceutiques SAS:

  • Tablets in bulk and finished packs

  • Capsules in bulk and finished packs

  • Pellets for filling in capsules

  • Granules for direct compression

  • Pellets or granules in sachets and stick packs

  • Effervescent formulations

Drug Delivery Platform

Athena has successfully launched products like the Voglibose 0.2 mg / 0.3mg Orally Disintegrating Tablet (ODT) and Metformin 500 mg + Voglibose 0.2mg/0.3mg tablet, with valued partners like AstraZeneca and Novartis in emerging markets.

In the Gastro segment, Athena has developed and launched products like the Mesalamine 500 mg/1000 mg sachet marketed under the trade name Rowasa® by Abbott and the Domperidone 10mg Orally disintegrating Tablet (ODT) marketed under the trade name Neogast® by Axapharma in Switzerland.

Drugs acting on CNS, is another area where oral drug delivery has given proven results in reviving some old molecules after introducing newer lifecycle products such as Prochlorperazine 5mg Orally Disintegrating Tablet (ODT), Zolpidem 5mg Orally Disintegrating Tablet (ODT), and Levocetirizine Orally disintegrating Tablet (ODT).

Pain Management has also been a rewarding segment for Athena with some successful launches like the Tramadol+Paracetamol 37.5+325mg Orally disintegrating Tablet (ODT) marketed under the trade name Paxiflas® in Spain as well as some ongoing registrations like Prednisolone soluble tablets and Fenofibrate capsules. 

Q3. Where are Athena's manufacturing sites located and what is their regulatory inspection history?

- Athena Drug Delivery System (Athena DDS)

Athena Drug Delivery System (Athena DDS) is a spin-off of Ethypharm India's operations. The company spun off from its parent - Ethypharm - in 2011. Today, Athena DDS is an EU GMP approved facility at Ambernath, about 60 km north of Mumbai in India. The development and manufacturing site employs 210 people. 

Athena Drug Delivery System situated in Mumbai, India is equipped with state of the art technology for oral solids. Furthermore, Athena DDS is WHO-GMP, EU-GMP, ANVISA, Russia GMP, Canada GMP, INVIMA, DIGEMID, and TGA Australia approved.

The facilities in India produce bulk products as well as finished formulations. Orally disintegrating tablets (ODTs) are some of Athena DDS' flagship oral solid products, as are modified release products either in tablet, pellet or capsule form. 

- Athena Inpharmasci (Athena IPS)

Athena Inpharmasci (Athena IPS) is an EU GMP approved facility at Prouvy, about 200 km north of Paris in France. With Athena IPS, Athena expands its manufacturing and packaging capacity by many folds in addition to its Athena DDS factory. 

Athena Inpharmasci's (Athena IPS) services include batch testing and release, primary and secondary packaging, and serialization to name a few. Its Prouvy, France office is a holding facility, which will play an important part in the near future to transfer some products to CMOs in Europe. 

These Mumbai, India and Prouvy, France facilities can handle a vast majority of dosage forms like bilayer tablets, capsules, sachets and stick packs, orally disintegrating tablets, oral solids and conventional dosage forms. They have GMP culture and conform to the highest standards in manufacturing and EHS.

Athena has received the following approvals; Eudra GMP (Inpharmasci, 2021), Canada GMP (2019), Russia GMP (2019), Australia TGA Clearance (2019), Colombia GMP (2017), EMA (2017), Iran GMP (2017), Kenya GMP (2017), South Africa MCC GMP (2017), Philippines GMP (2017), Peru BPM (2017), Tanzania GMP (2016), Zimbabwe MCAZ GMP (2016), Thailand GMP (2015) and Uganda GMP (2015).

Athena also has a Chinese operation dealing with R&D for Chinese products, from which it has filed two products so far. 

Q4. What are the environmental sustainability initiatives taken by Athena?

Athena is committed to environmental sustainability and is continually reviewing and improving its efforts to lessen the company's impact on the environment. Athena conducts responsible business practices and upholds high ethical standards. 

Athena is delivering the most strategic approach to Environment, Health & Safety (EHS) practices and programs in order to improve in the areas of climate change, product stewardship, and access to potable water. 

Athena's focus is to reduce greenhouse gas emissions, increase energy efficiency, minimize releases to air and water, and decrease water use and waste. It also focuses on continuous improvement and minimizing accidents and injuries to benefit employees and the global society.

Q5. What are some of the key technologies offered by Athena?

Innovation is Athena's forte, the highly trained and specialized team of scientists engaged in developing products bring added value to clients' portfolios and enhance patient convenience and compliance. 

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)

  • Melts rapidly
  • No water required
  • Taste masked and flavored

- Customized Drug Release (SR; EC; Zero order; Sublingual)

  • Extended release technology
  • Bioavailability enhancement for poorly soluble drugs 
  • Multi-particulate control release technology

- Fixed Dose Combination (FDC)

  • Athena develops innovative products on this platform

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