Manufacturing Facilities
All our manufacturing facilities are a testament to the spirit of excellence we embody and epitomize. Best in class manufacturing facilities at Baddi (Himachal Pradesh, India) and Kalyani (Near Kolkata, West Bengal, India) are the pillars of Fresenius Kabi Oncology Limited. Strengths such as high-tech equipment, large installed capacity, most modern infrastructure with the modern containment technology, immaculate documentation and stringent quality standards enable our manufacturing facilities to fulfil optimal quality and safety standards in every phase of production.
Generic drug industry has come a long way and in our aim to deliver high-quality API’s in the field of Oncology. We aim at acquiring the best technology which ensures manufacture of world-class finished products at a competitive price. In our pursuit to manufacture highest quality API’s, we remain fully committed to our responsibilities towards safety, health and environment. The Company is one of the select few manufacturers worldwide that have all major international registrations for the production of cytostatic agents, ranging from the preparation of starting material, followed by production of API and manufacture of finished products.
Our facilities have been inspected & approved by-
PU Kalyani: EDQM-AIFA, Health Canada, COFEPRIS-Mexico, KFDA, ANVISA-Brazil
PU Baddi: EMA-RP Darmsdtadt Germany, TMMDA-Turkey, ANVISA-Brazil, Ministry of Health – Russia, KDFA, Health Canada, GCC (Gulf Health Council), Peru - Ministry of Health (DIGMID), SFDA- Saudi Food & Drugs Authority, Republic of Sudan- Federal Ministry of Health National Medicines & Poisons Board
Active Pharmaceutical Ingredients Manufacturing at PU Kalyani
Kalyani facility manufactures oncological and non-oncological API’s in separate and fully segregated areas. The plant develops, validates and manufactures key APIs, maintaining the highest levels of international quality and GMP standards, while ensuring high productivity and cost competitiveness. A new high-tech commercial plant for manufacturing oncology and high potency API’s has been constructed at the facility to meet future demands. Production through this facility shall be utilized for in-house consumption and export to major generic companies in the world.
Key Manufacturing Capabilities & Attributes:
Dosage Formulation Manufacturing at PU Baddi
The Fresenius Kabi Baddi manufacturing facility is located in this major industrial hub of Himachal Pradesh, India. This facility is equipped with all kinds of sophisticated equipments and trained manpower for carrying out the processes as per the international regulatory standards.
The facility is dedicated for production of oncology products for human consumption. This Plant has dedicated blocks for formulation of cytotoxic Oral Solid Dosage (Tablets & Capsules) facilityand Cytotoxic Liquid (Aseptic & Terminally sterilized) and Lyophilized Injectable facility.
Full consideration has been given to the aspect of containment by extensive usage of closed Restricted Access Barrier Systems (cRABS) and Isolator technology.
Baddi Plant is approved by authorities like EMA, ANVISA, MCC, INVIMA, BPOM, KFDA, Peru, Saudi Arabia, Russia GMP and its products have regulatory approvals in more than 30 countries across the world. A multitude of superior finished dosage forms are the forte of Baddi facility. The commitment to Quality by Design (QbD) is what we have been able to accomplish through our formulations and remain to bring the best of finished dosage forms through our most modern manufacturing unit located in the heart of Himachal Pradesh, India.
Therapeutic Areas
Cancer is the leading cause of death worldwide. More than 1 million people are diagnosed of cancer in India every year. Various types of cancer appear to be more frequent due to factors such as ageing, environmental conditions and lifestyle choices. Cancer disease progression depends on the cancer type and the care that the patients receive, which is why an accurate assessment and proper management of the complex therapeutic regime becomes the cornerstones of cancer care.
We, at Fresenius Kabi Oncology Limited, are committed to improve the quality of cancer care through innovative endeavours in order to become a most trusted partner in the chosen therapeutic areas. Our state-of-the-art Innovation &Manufacturing facilities and dedication towards following the most stringent quality standards bring this commitment alive. Right from the herbal plantations, R&D and the unparalleled manufacturing expertise, we ensure to create the most effective and quality-embraced medicinal products to implement drugs with minimal side-effects.
Our cytostatic range combines the new generation drugs in chemotherapy with time tested products to meet all therapeutic protocols. Our comprehensive product range includes formulations for the treatment of lymphomas, leukemia, carcinomas of ovary, breast, lung, head & neck, prostate and gastrointestinal tract.
Our product range caters to the following therapeutic areas:
- Breast Cancer
- Lung Cancer
- Ovarian Cancer
- Head & Neck Cancer
- Prostate Cancer
- Hematological Malignancies
- Gastrointestinal Malignancies
- Brain Tumors
- Supportive Care
