There has been an increase in the number of pharmaceutical manufacturers seeking for GMP certifications from across the country. In Andhra Pradesh alone, about 150 units have been issued WHO-GMP certifications so far and this number is expected to grow gradually. On the other hand, about 100 units are likely to close down their operations out of estimated 200 units, which are not GMP certified at present in the state.
The Andhra Pradesh Drugs Control Administration (APDCA) has given sufficient scope for units willing to become GMP compliant to upgrade their units and obtain WHO GMP certification.
India is one of the top manufacturers of bulk drugs and is among the top 20 pharmaceutical exporters in the world. The industry manufactures almost the entire range of therapeutic products and is capable of producing raw materials for manufacturing a wide range of bulk drugs from the basic stage. The WHO GMP approval is an important pre-requisite for several global sourcing programmes. AP has been recognized as the hub for bulk drugs production in India, and is also witnessing the growth of quality conscious manufacturers, including the small and medium scale companies.
Among the pharma companies from Andhra Pradesh that have either obtained WHO GMP certification or planning to establish GMP compliant manufacturng units, Aurobindo Pharma, during mid 2005, has obtained WHO approval for its Unit III facility in Bachupally in RR District of Andhra Pradesh. Matrix Laboratories has been awarded World Health Organisation's Good Manufacturing Practices (GMP) certification for two of its active pharmaceutical ingredients (API) facilities located near Hyderabad and Visakhapatnam, during July 2005.
Transgene Biotek is upgrading its existing manufacturing infrastructure and expects to obtain WHO GMP and USFDA approvals by end of 2007, boosting its efforts to roll out new products. AVRA Labs has acquired 21 acres of land to set up a unit at Pharma City, Parawada near Visakhapatnam to meet its expansion needs, which will be a large scale manufacturing (GMP compliant) facility for APIs and other chemical entities.
Several medium level companies in Andhra Pradesh such as Glochem Industries, Saraca Labs, Shodhana Labs have GMP certified manufacturing units.