API Manufacturing Sites
We presently have 11 manufacturing facilities across India. Over the years we have leveraged organic growth and acquisitions to strengthen both our manufacturing infrastructure. All these 11 manufacturing facilities have been multipurpose with reactor capacities of around 1500 KL. We have 4 manufacturing facilities located in Medak, Hyderabad, 5 in Mumbai (2 in Tarapur and 1 each in Badlapur, Taloja and Dombivli) and 1 each in Gurgaon, Haryana and Solapur, Maharashtra. We have 5 API manufacturing facilities and 6 Intermediate manufacturing facilities. Of these 6 facilities are ISO 9001-2008 and cGMP compliant, 3 of them are inspected and approved by the USFDA and another 2 of these facilities is expected to be inspected by the USFDA by 2012. These facilities allow us to supply our products in regulated markets on registration and approval of the products with the relevant authorities.
Our manufacturing facilities are designed to manufacture a variety of APIs and Intermediates using a combination of processes. Our flexible manufacturing infrastructure enables us to expand our product range and change our product mix in response to changes in customer demand and to serve customer requirements ranging from laboratory scale research to commercial production. We have the capability to handle several complex reactions in a cost-effective manner with scale of operations ranging from multiple, multi-product facilities with capacities varying from gram to kilograms and multi tons. These complex reaction capabilities include cryogenics, cyanation, enzymatic, chlorination, carboxylation, hydrogenation and organoborane chemistry – across lab-scale, pilot-scale and commercial scale.
Over the years we have invested and will continue to further invest in our manufacturing facilities and infrastructure with a pre-set objective of enhancing our organic growth capabilities.
We initiated the first phase of the expansion cum up-gradation program at Gurgaon Unit in Fiscal 2009, which was completed during the same fiscal. Besides this in Fiscal 2009, we invested in effluent treatment plant to ensure that we remain a Zero discharge facility. During this fiscal we were also in the process of taking up the second phase of the project wherein two new production blocks were to be constructed along with a pilot plant. The expanded capacities were to be utilized to manufacture products primarily under Cardiovascular, Anti-Retroviral, Anti-Asthmatic and Anti-Platelet Therapeutic Segments. Most of the products to be manufactured from these two new production blocks were meant for exclusive uses by MNCs from the US and the Europe for regulatory markets. Majority of our business from this facility relates to regulatory market. During Fiscal 2010, this facility was upgraded and refurbished including QA/QC departments to stand regulatory audits like USFDA/ EDQM/TGA audit. This facility was inspected in 2009 and received USFDA approval in April 2010. Further, we have invested funds in the third phase for expansion of facilities and to increase the capacities to manufacture new products. During H1 2011, the expansion of the plant including QC Lab expansion continued to cater products manufactured for specific customers.
Located in western India at Solapur, this USFDA inspected site is the largest manufacturer of Ephedrine and
Pseudoephedrine in India. In addition to fermentation capabilities, this site has a multipurpose plant for manufacturing APIs.
We continued the expansion work during Fiscal 2010 initiated earlier to make the unit multipurpose manufacturing facility for various APIs and Intermediates and custom synthesis projects. The additional space available has been utilised for the new production blocks and suitable supporting utilities, for which the capex is being incurred. During H1 2011, the expansion work continued uninterruptedly so as to ensure that the facility gets USFDA compliant. New production blocks are also getting filled with equipments earmarked for specific US customers. Up-gradation of utilities and ETP are major areas being improved for infrastructure up-gradation. New HVAC systems are being added in production block and also in pilot plant so as to make them customer compliant. Production volume of existing products and major custom synthesis product made for US market is being expanded further. Further, we plan to develop this facility as an USFDA approved facility.
We acquired this unit in December 2008. Investments have been made to expand and upgrade to cater to the regulatory and niche market. It was also decided that this facility shall be solely dedicated for Oncology segment for all markets, including regulated markets. It is being further upgraded with two separate projects for clean room areas, addition of isolator, setting up of new process development lab specialized in handling Oncology products and expansion of ETP infrastructure. We have designed this facility and installed quality systems and cGMP standards, thereby making this facility suitable for inspections from regulatory agencies like USFDA, EDQM, TGA and others.
Dombivli Site, Near Mumbai
We acquired this unit from Watson Pharma Private Limited from January 1, 2009. After acquiring the facility, it required up-gradation to make it a multi-product facility as per our Company’s philosophy. In order to do so, the facility was developed to meet our expected internal standard and requirement so that we are able to harmonise quality standards of this facility with other appropriately designed facilities of our Company. It was decided for various reasons including logistics, cost considerations, facilities existing and available, that the Dombivli Unit would be used for catering the manufactured products in the regulatory market. To achieve the desired output, the existing facility was required to be upgraded including QA/QC departments to pass the stringent regulatory audits like USFDA/ EDQM/ TGA audit. These audits and certifications help in expanding the market for the existing products business and also attract customers for exploring the possibility of manufacturing new products forregulated markets. Thus, the investment had to be made in the facility to increase production capacities.
Dombivli Unit was inspected and approved through audits by USFDA, EDQM and TGA which is helping us to expand market for existing products and encouraging addition of new products needing further investment. We received PMDA Japan accreditation in July 2009 and TGA certificate in April 2010. This facility was last inspected for EDQM and USFDA in February and December 2010 respectively. Further, in an attempt to ensure product rationalization and optimum capacity utilization per cub met of volume, the capacity and GMP upgrade also is resorted to. Dombivli facility is being aligned for producing high value-high volume products. This will enable us to cater to a contractual business with a global generic player pursuant to a regulatory approval. This facility is being further upgraded for safety, fire hydrant system and rationalization of solvent storage.
