Small Molecules

Biocon is a leading global supplier of complex APIs (active pharmaceutical ingredients) manufactured via synthetic chemistry, peptide chemistry, fermentation and chromatographic purification which we provide to leading pharmaceutical companies around the globe. Our large scale, world-class manufacturing and research capabilities and our proven track record of cGMP compliance have enabled us to build significant brand equity worldwide as a trusted partner. Since the late 1990s, we have emerged as a preferred APIs partner for over 1,000 pharma companies in more than 100 countries and have long-term business relationships with many of them. Having built a strong Small Molecules business around a robust portfolio of APIs, Biocon has leveraged it technical competencies and forward integrated to generic finished dosages.

Small Molecule APIs

Biocon is one of the leading global suppliers of complex small molecule APIs spanning statins, anti-obesity agents, anti-diabetics, immunosuppressants, peptides, oncology products and anti-fungals. Our products are sold to third party customers who in turn formulate and sell the finished dosages in global markets including the U.S., Europe and large emerging markets.

We have built one of the largest fermentation based bulk drug capacities for statins and immunosuppressants globally. We are now one of the largest statins manufacturers in the world supplying our drug substances to over 60 countries.

Our expertise in fermentation technology and synthetic chemistry give us a key competitive edge in developing new APIs, focusing on compounds that involve highly complex manufacturing, high potency compounds or a mix of both. In addition, Biocon can also offer pellets / premixes of various APIs depending on both customer and market requirements, and has a strong development pipeline in the oncology space.

We have emerged as a preferred partner for multiple global pharma companies and have multi-year associations with our clients with a reliable regulatory track record and culture that assures quality and compliance in whatever we do.

Key API Portfolio:

Cardiology

• Simvastatin
• Pravastatin
• Atorvastatin
• Rosuvastatin
• Fluvastatin
• Dabigatran
• Sacubitril/Valsartan
• Apixaban
• Rivaroxaban

Immunosuppressants Basket

• Tacrolimus
• Sirolimus
• Everolimus
• Mycophenolate Mofetil (MMF)
• Mycophenolate Sodium (MPA)

Anti-Diabetics

• Vildagliptin
• Linagliptin
• Sitagliptin
• Dapagliflozin
• Pioglitazone
• Repaglinide & peptides (Liraglutide/Semaglutide)

Multiple Sclerosis

• Glatiramer Acetate
• Fingolimod
• Teriflunomide

Other Key Products

• Orlistat
• Fidaxomicin
• Mirabegron

Generic Formulations

Our Generic Formulations strategy hinges on leveraging our expertise in developing complex Drug Substances and Drug products; the ability to vertically integrate across APIs and finished dosage forms; and an exemplary track record in global regulatory audits. These strengths are helping us address an important need in the market – continuity of supply for quality drug products – to capture a larger portion of the value chain by developing our own formulation dossiers that incorporate our differentiated APIs. The pipeline comprises oral solids and parenteral formulations in both the potent and non-potent compounds categories, in the core therapeutic areas of metabolics, cardiovascular,oncology and immunotherapy. To support our filings, we commissioned our first oral solid dosage facility in Bengaluru in 2017. The facility successfully completed several regulatory audits subsequently following our various filings in the U.S. and Europe. We have built commercial infrastructure to support this initiative in the U.S. Our brand equity as a reliable API supplier helped us, in a very short time, to build a good network of accounts that includes wholesalers, retailers, Pharmacy Benefit Managers (PBM), Health Management Organizations (HMO) and Group Purchasing Organizations (GPO). We introduced Rosuvastatin Calcium tablets under our own label in the U.S. in 2017. Since then, we have also launched formulations of Atorvastatin and Simvastatin. We commercialized our Rosuvastatin formulations in Europe through a local partner in January 2018.

OUR PRODUCTS

• Rosuvastatin - Launched in United States & EU
• Simvastatin - Launched in United States
• Atorvastatin - Launched in United States
• Fingolimod - Tentative Approval (United States)
• Pemetrexed - Tentative Approval (United States)

Outlook

Our capabilities in fermentation technology-based manufacturing have enabled us to straddle a complex matrix of manufacturing requirements for high value, niche APIs.

To offset the growing commoditization in statins, we have been moving towards a more profitable product mix with a better contribution from products like immunosuppressants where we have developed strong capabilities. This is already leading to better earnings quality in the Small Molecule APIs business.

We have a clear strategy to pursue the Generic Formulations opportunity in both developed as well as emerging markets by utilizing our well-established R&D Capabilities and cGMP compliant manufacturing facilities, including our injectable formulations and fill-finish facilities. To feed our small pipeline and target early-market entry, we are evaluating new molecules. Cumulatively, we expect to file 15-20 applications over the next few years. We will look at all options including First-to-Files and Para IVs as part of our plans for the Generic Formulations business. The investments in building commercial manufacturing scale for potent / oncology APIs and drug products will enable us to aggressively address global opportunities in the coming years.