Manufacturing

We continuously work towards enhancing the affordability of medicines worldwide by investing in our manufacturing capital through facilities that are cGMP compliant and approved globally.

We have leveraged and invested in our manufacturing capital through facilities that are cGMP compliant and approved globally. This has facilitated the company to attain a global leadership position in the pharmaceutical sector.

The confidence of patients and healthcare professionals in our products has strengthened over the years due to consistent and timely delivery of highly dependable products. We continue to strive to retain this confidence by diligently manufacturing high quality medicines and implementing innovative, path breaking technologies to deliver superior quality products.

Taking the principle of 'Caring for Life' forward, we have worked towards enhancing the affordability of medicines worldwide. We were able do this through cost and complexity rationalisation, product portfolio enhancement, process/yield improvements and alternate vendor development.

We have over 1500 products in 65 therapeutic categories available in over 50 dosage forms. These capabilities range from the development of a simple molecule to highly complex multi-chiral centres molecule with a distinction of affordability and highest quality. Our capacities include our own facilities and in licensed facilities which support both generic and the biotech business. Our investments in manufacturing capital include development of new drug delivery systems, facilitation of infrastructure supporting API and formulation developments and strengthening of platform technologies.

This year (2017-18), we commenced commercial production at our state-of-the-art manufacturing unit for formulations at Sikkim II. We also ensured the formulation manufacturing of existing facilities at Indore and Goa to service increasing demand across markets. Additionally, we commissioned an extra manufacturing capacity of 10 Metric Tonnes/year specifically for Oncology API at Bommasandra in Bengaluru along with commissioning a pilot facility for micro/flow reactor at Kurkumbh as a step towards continuous manufacturing process. Besides the new facility, all the existing facilities are upgraded regularly to meet current cGMP, Safety, Health and Environmental Standards. Various initiatives are taken towards energy and water conservation. Our journey towards achieving operational excellence across functions was driven through our efforts to de-bottleneck resources, cycle time reduction, setting internal benchmarks for material and manpower productivity.

We have scaled up several key APIs through yield improvement, cycle time reduction and cost improvement projects. The continued focus on process and operational improvements has resulted in reducing solvent losses to less than 15% thereby reducing environmental impact. Similarly, batch size increase of about 45 products in formulations was carried out during the year resulting in improvement in productivity. We are now on a path to digitise the manufacturing operations by integrating all process-related machines to server to capture real-time process parameters for better operations control, improvement in productivity, and enhanced compliance status.

Cipla’s state-of-the-art manufacturing facilities are cGMP compliant in conformity with national and international standards. Several dosage forms and APIs manufactured at these facilities continue to be approved by major international regulatory agencies including the US FDA, MHRA (UK), TGA (Australia), Federal Ministry of Health-Germany, SAPHRA (South Africa), the Department of Health (Canada), INVIMA (Columbia) ANVISA (Brazil), the Danish Medical Agency, WHO and Ministry of Health of various countries.

API

Our API legacy spans over five decades of having serviced the world’s largest pharmaceutical companies with more than 200 generic and complex APIs.

With its 50+ years’ experience in manufacturing APIs, Cipla has produced 200+ generics and complex APIs. Our API Business covers 60 countries across the globe. The Company continues to be a preferred partner to some of the largest generic formulators globally due to our focus on niche molecules and quality. A strong dedicated team of over 250+ scientist aids the Company to differentiate itself with the capability to handle wide range of chemistries and complex molecules. Cipla has a strong partnership with the world’s largest generic pharmaceutical companies.

The Company plans to enhance its API R&D and manufacturing capacities in therapeutic areas such as Respiratory and Oncology and conduct backward integration for manufacturing of Key Starting Material and critical API intermediates to have more control on the supply chain. Cipla is keen to partner with leading generic companies for their new products to further expand in markets such as Japan, China and the Commonwealth of Independent States (CIS) countries.Cipla has four sites with dedicated facilities for high potent APIs, corticosteroids, polypeptides, hormones, steroids and oncology with a total capacity of over 1,000 MT across.

The Company has three API R&D Centres, two pilot plant and two process safety screening labs. All facilities are cGMP compliant and approved by the major international regulatory agencies including the US FDA, EDQM (Europe), PMDA (Japan) WHO, TGA (Australia), and KFDA (Korea). Cipla’s plants have zero liquid discharge waste water treatment facilities that include ETP with Multi Effect Evaporators (MEE), Agitated Thin Film Dryer (ATFD), Vertical Thin Film Dryer (VTFD) and Reverse Osmosis (RO) facilities.

Formulation development

We are consistently developing a formulation portfolio and pipeline across our formulation facilities:

  • Formulation development is focused on Respiratory, Oncology, ARVs, Ophthalmology, CNS, CVS among others
  • Over 60% of the products are developed for international markets
  • The pipeline has over 250 products, including complex formulations
Platform technologies

We have made strategic investments in platform technologies resulting in enhanced drug safety and an increase in efficacy through a targeted therapy approach. The aim of these investments is to formulate differentiated products that overcome the key challenges of conventional drug delivery systems and add value to current products.

Over the years, we have developed and adopted a range of platform technologies such as Nanotechnology, Liposomal, Modified Release Technology, Inhalation Technology, Microsphere, Hot Melt Extrusion, Oral Disintegrating Technology, Peptides, Implants, Intra-vaginal ring and Depot Injections.

Having built technologies in the field of respiratory devices, we aim to facilitate effective drug delivery across dosage forms. These include breath-actuated inhalers and unit-dose nasal sprays.

In an era of digital disruption, we have always been developing a family of digital devices such as peak flow meters and digital inhalers that will connect patients with doctors, provide portable diagnostic solutions, assist them in self-management of diseases and improve adherence to the prescribed dosage schedule.

Additionally, we are building strong skill-sets in engineering design, systems modelling and simulation. We have developed Computational Fluid Dynamics (CFD) toolkits to support rapid development and high performance of respiratory devices. Device resistance significantly impacts optimal drug delivery and respiratory comfort during medication. 

We conduct analysis of medication devices as well as disease ailment detection. Based on air flow analysis and Design of Experiments (DOE), we conduct a basic simulation to determine device resistance, which helps arrive at optimised device models. The best model is further analysed to deliver devices that optimise the patient experience and meet their evolving needs. 

We continue to build our future pipeline of complex products with our established robust portfolio selection process, providing early launch capabilities along with Intellectual Property (IP) advantages. Selective vertical integration, scale and more importantly its investments in manufacturing and quality have helped the company build a quality product pipeline.

Our APIs cover a wide spectrum of therapeutic categories with 30+ Drug Master Files (DMF) filed in FY2016-17 in various countries. We are also ramping up our filings for regulated markets with a robust pipeline of over 50 APIs at various stages of development. We expect to continue the strong pipeline building momentum for the times to come.

Strengthening API R&D through innovative techniques

To support API development, we have invested in infrastructure and developed in-house capabilities. We have used several tools to characterise the physicochemical properties of molecules to ensure they meet FDA requirements.

X-ray powder
diffraction
hyphenated with DSC

inVia Raman
Microscope

Morphology G3-ID

Nuclear Magnetic
Resonance
Spectoscopy

These new characterisation tools have enhanced the pace of product development and dossier filings and helped us perform in-house characterisation of the molecules for cost optimisation.