Shuchi Nahar's Weekend Blog!

  Hikal – Company Overview Shuchi.P.Nahar Twitter: @shuchi_nahar Link to my previous blog for detail explanation on  What are CDMO and their wide scope: 1 .  https://myweekendspot.blogspot.com /2020/07/ what-is-so-attractive-about-cdmos-in.html   2 .  https://myweekendspot.blogspot.com /2020/07/a-masterclass-on-global-custom.html 1.  Company Overview Established in 1988, Hikal is predominantly a B2B player that provides intermediates and active ingredients to global pharmaceutical, animal health, crop protection and specialty chemical companies. Hikal today is one of the leading global suppliers to the Life Sciences industry. Company is having six sites providing a multitude of services across the value chain. Figure:1 Business Snapshot The pharma business is currently divided almost equally between generic active pharma ingredients (APIs) and contract development and manufacturing organisation (CDMO) businesses. Leading Sustainable Technology driven company serving the Crop Protecti

Laurus Labs : Company & Business Overview Shuchi.P.Nahar Twitter:  @shuchi_nahar  1.   Company Profile & Background Laurus Labs is a leading R&D driven pharmaceuticals company established in 2005 with its headquarters in Hyderabad. It is among the leaders in the manufacturing of Active Pharmaceutical Ingredients (APIs) for Antiretroviral (ARV) and Hepatitis C (Hep-C) formulations. Other major API segments include therapeutic areas such as Oncology, Cardiovascular, and Anti-Diabetes. ·        From a one-product company in 2010 to an Active Pharmaceutical Ingredients (APIs) company thereafter, company has now emerged as one of India’s leading manufacturers of generics APIs for various complex therapies. ·        Company is thriving on growth opportunities in formulation manufacturing, addressing the critical needs of the world’s key pharmaceutical markets. ·        Over the years, the most important enablers of this transformation has been their People, Plants, Products, and

Neuland Laboratories Limited -  Company Overview  Shuchi.P.Nahar -  @shuchi_nahar Neuland is a leading manufacturer of active pharmaceutical ingredients (APIs) and an end-to-end solution provider for the pharmaceutical industry’s chemistry needs. The Company operates in the market using two main business models - Generic Drug Substances (GDS) where they cater to the needs of the Generic players and Custom Manufacturing Solutions (CMS) where they primarily work with innovators by helping them bring critical products to the market. CDMO is the emerging growth segment of the company with 13 to 17 Molecules in development phase. 1.      Business Performance Neuland lab (NLL) has posted revenue of INR 2,054mn with 13.5% YoY increase, which was 4% below. The revenue growth was mainly driven by the CMS segment, led by 32 molecules (Development + Commercialize) with speciality API segment, which grew by 33.2% in Q1FY21. EBITDA margin expanded by 622bps to 16.5% level, which was 219bps hig

Biosimilars - The upcoming trend in Pharmaceutical Sector Twitter Handle: @shuchi_nahar 1. What are the trends impacting the global pharmaceutical sector? 2. How are Biosimilars different from Small Molecules? Figure 1: Comparison of Small Molecule and Biosimilars Figure 2: Molecule Size - Small Molecules to Biologics 3 . Procedure for Biosimilar US FDA Approval  Biologics contain active substances derived from living cells or organisms, the development of a biosimilar is much more complex than the process for developing a generic drug. A biosimilar requires the creation of a new manufacturing process and a custom cell line since the reference product’s manufacturing process is proprietary and not publicly available.  Due to the complex nature and production methods of biologics, relatively minor changes in manufacturing processes may significantly affect product quality, safety, and the criteria by which similarity is determined. *Below (Figure 3) is just an illustrative example for t