Therapiva is an emerging generic pharmaceutical company backed by a strong and innovative R&D facility and a world-class API manufacturing facility. It has a robust product portfolio spread across various therapeutic areas, capable of handling new, complex and hazardous reactions. Therapiva supplies NCEs, cGMP intermediates and KSMs to global innovators. It is equipped with flexible, versatile and advanced infrastructure, tailored to fit any complex chemistry requirements of Innovator’s development pipelines.
The manufacturing facilities comply with all regulatory guidelines and requirements of current Good Manufacturing Practices (cGMP) and are successfully inspected/approved by most of the global health and regulatory agencies.
A GMP approved facility spread over an area of 12 acres and situated in Pashamylaram, Patancheru, Therapiva unit-I (TU-I) has 6 production blocks and 3 clean rooms. This unit manufactures API and intermediates catering to the less regulated markets. Below are a few highlights
6 production blocks and a pilot-plant for scaling up of new products
Total reactor volume of approximately 140 KL, with over 70 reactors with a balance of Stainless steel and glass-lined reactors.
Capable of handling a broad spectrum of reactions and a wide range of process parameters.
The facility is CGMP certified and plans to be certified by US FDA, EDQM, WHO, TGA (Australia) and PMDA (Japan) by 2022.
A Zero discharge facility with biological treatment, multiple-effect evaporators and reverse osmosis systems in-house.
3 clean rooms (Class 100,000) with 500L, 2000L and 3000L crystallizers
A USFDA approved facility spread over an area of 5 acres and situated in Jeedimetla, Hyderabad, Therapiva Unit-II (TU-II) has 8 production blocks and 5 clean rooms. This unit manufactures APIs catering to regulated markets like the US, EU, Mexico, Japan, Canada, etc. Below are a few highlights: Eight Production blocks: Eight production blocks and a state of the art finished goods area.
8 production blocks with a total production volume of 163 KL
Total reactor volume of approximately 163 KL, with over 88 reactors with a balance of Stainless steel and glass-lined reactors.
Dedicated safety team and standards at par with the industry.
The facility is approved by various regulatory bodies like USFDA, EDQM, COFEPRIS, KFDA, MHRA, PMDA etc.
Employs a strong workforce of over 350+ employees
5 clean rooms (Class 100,000) with 70L, 500L and 2000L crystallizers.