IBU

Generic Business

Ex- US Markets (Regulated ROW markets)

Alembic has its footprints in almost all major regulated markets across the world. Our Generic portfolio consists of a number of molecules across different therapeutic segments with a focus on developing products offering multiple developmental challenges. We also offer a rich pipeline of products which are in various stages of development.

At Alembic we manage the entire value chain – right from producing the active ingredients to producing the packaging material and doing the BE studies in-house. This backward integration into the entire value chain provides a distinct cost advantage to our customers. Our in-depth knowledge of market specific regulations and intellectual property rights through dedicated market specific teams gives us an edge in terms of offering quality dossiers with minimal or no regulatory queries.

We believe in focusing on our core strengths of managing Product Development, Manufacturing and Regulatory aspects of the product. We always believed that in most of the ROW markets, partnership and alliances are of utmost importance. It is because of this philosophy that today we are able to forge very strong tie-ups and partnerships with Global Generic players and Multinationals. We believe in building sustainable customer relationships. While working with multiple partners, we respect confidentiality and ensure total customer satisfaction.

EU and UK

Present in Europe through its wholly owned subsidiary, Alembic Pharmaceuticals Europe Ltd, Alembic has an experience of more than a decade in the highly complex and regulated UK and Europe market. We have adapted and developed along-with the highly dynamic market conditions. Having started with a contract manufacturing model, we have now evolved in the value chain by offering ready MA’s and ready to file dossiers. Proven expertise in product development and strong regulatory knowledge has helped us in developing a robust product portfolio of EU-CTD dossiers offering Day 1 launch upon patent expiry.

Products from Alembic can be seen in almost all the EU markets, especially because of our strong and strategic licensing tie-ups with leading national companies along top Pan-European companies like Teva, Sandoz, Stada, and Orion among others.

Business Model:

Alembic offers the following options for partnering for EU and UK markets

  • Out licensing of ready MA depending on the availability.
  • Out licensing of EU CTD dossier

Both the above options are available with a backup exclusive supply contracts.

Some of our major strengths for the Europe and UK market are as follows:

  • Robust supply chain with dedicated demand planning team handling 800+ SKUs of different products for different markets in EU.
  • Dedicated team of Regulatory experts capable of handling multiple Regulatory procedures at a time.
  • Successful track record of launching upon Day 1 of patent expiry.
  • Backward integration on most of the products offers better cost competitiveness for successful participation in major tenders of Germany, UK and NL.
  • Ability to offer EU release if required.

Brazil

With a strong regulatory set up and having Formulation and BE facilities approved by ANVISA, Alembic is well poised to penetrate the Latin American market with Brazil as the beachhead. Alembic today on the back of exemplary research initiatives has developed capabilities of meeting the regulatory requirements of this highly complex market from a regulatory perspective. Several dossiers have already been filed with ANVISA through our partners. We have a robust product pipeline with zone 4b stability data which can be offered for licensing to interested customers.

Business Models:

  • Out licensing of a ready to file dossier with Brazilian PE and BE study.
  • Offering EU CTD dossier with zone 4b stability data with incremental development to be carried out by interested customers.

Both the above options are available with a backup exclusive supply contract.

Algeria

The largest country in North Africa offers huge opportunities coupled with major challenges. With several entry barriers for import of generic dosage forms, no major Indian company has been able to make headway in this market. Alembic has established a local manufacturing set up along with one of the largest distributors in Algeria, M/s Adwaya Mami, for manufacturing and selling the products in Algeria. With the JV established in the name of Alembic Mami SPA, Alembic today is firmly saddled to establish itself as a frontline generic player in the Algerian market. The JV would leverage the R & D strength of Alembic and the strong distribution set up of Adwaya Mami to penetrate itself in the Algerian market. The strategy is to focus on high growth niche products in Cardio Vascular, Neuropsychiatry & diabetology apart from making significant offerings in Gastro Intestinal and Anti-Bacterial range. Having already received a couple of approvals, Alembic is all set to launch its marketing and sales operations in the country.

Australia

Alembic is represented in Australia through its wholly owned subsidiary; Alembic Pharmaceuticals Australia Pty Ltd. Alembic has established partnership with all major generic companies in Australia either directly or indirectly. With an established set up in Australia and a dedicated Regulatory team, Alembic is well equipped to run regulatory procedures on its own and offer clones of MA to interested partners. With well-established market credentials, Alembic is a partner of choice for most of the large generic companies in Australia. We have successfully closed several regulatory procedures and offered Day 1 launch to our partners. We adopt business models in line with dynamics of this market and are actively seeking partnership opportunities to judiciously employ either one or a mix of the models listed below:

  • Out Licensing of ready dossiers with Australian BE study.
  • Out licensing of EU CTD dossier with BE and filing to be done by the partner.
  • Offering clones of a ready MA with Alembic.

South Africa

Having received SA MCC’s approval for the manufacturing facility for Oral Solids and a couple of product registrations, Alembic’s pathway is opened to explore Africa’s biggest and the most regulated market. A rich pipeline of EU CTD dossiers, with CDP against the SA reference products, offers an opportunity to file dossiers immediately with the MCC. Helped by a strong product portfolio and a highly promising pipeline of pending product registrations, Alembic is well positioned to realize the true potential of this market.

Alembic has partnered with the well-established generic players in the market to leverage its strong R & D pipeline of products The strategy is to offer an out licensing model for this market.

Canada

Alembic is represented in Canada through its wholly owned subsidiary; Alembic Pharmaceuticals Canada Ltd. Alembic has established partnership with all major generic companies in Canada. Proven expertise in product development, strong regulatory and IP knowledge and TPD approval of the manufacturing site has helped us in penetrating this highly regulated North American market. Alembic has several ANDS approved and a robust product portfolio of Canadian dossiers. Alembic has a successful track record of launching products on Day 1 of patent expiry.

We adopt a flexible business model to suite the customer requirement. The various partnership opportunities which can be adopted are listed below:

  • Out Licensing of ready dossiers with Canadian BE study.
  • Out licensing of EU CTD dossier with BE and filing to be done by the partner.
  • Offering cross license for a ready MA available with Alembic.