Scale up and Registration Batch Manufacturing
CPS offers Phase III and Commercial-Scale cGMP contract manufacturing services to pharmaceutical industry.
Our team has expertise in all aspects including process development, scale-up and registration for drug product manufacturing. Also we provide services for filing dossiers to regulatory agencies in eCDT format.
Our services include:
- Scale-up & Phase III to Commercial Manufacturing
- ICH Compliant Stability Studies
- CMC and Regulatory support for filing dossiers to regulatory agencies
- Dr. Reddy’s has manufacturing facilities (Formulations TechOps, FTO) to cater to the needs of customers in all geographies, therapeutic categories and dosage forms. All manufacturing facilities fulfill GMP requirements. Many of the facilities meet all US and EU guidelines for producing large scale clinical and commercial material.
- The FTO-3 site at Hyderabad is Dr. Reddy's Flagship site for oral solids manufacturing and is FDA and MHRA, ISO 9001, ISO 14001 approved and is the first plant in India to be OHSAS 18001 approved.
- The FTO-7 site at Vizag is a State of the art high potent USFDA approved manufacturing facility.
- Dr. Reddy's Shreveport facility in Louisiana, USA has a long history in contract development and manufacturing services and specializes in Oral Solid products for prescription as well as OTC markets. In addition, this site also offers commercial manufacturing of non-sterile liquids, creams and ointments.
|Formulation Units||Location||Dosage Forms||Market|
|FTO-1||HYDERABAD||Oral solid, Injectable.||CIS, ROMANIA|
|FTO-2||HYDERABAD||Oral solid||EU, CIS|
|FTO-3||HYDERABAD||Oral solid||EU, USA|
|FTO-6||BADDI||Oral solid, Semi solids, Injectable||INDIA|
|FTO-7||VIZAG||Oral solid, Injectable – High potent||EU, USA|
|SHREVEPORT||LOUISIANA||Oral solid, Semi solids||USA|
|BEVERLEY||UK||Oral solid packing||EU|
|VIZAG||Oral solid||EU, USA|
- The pilot plants in each facility are designed to be directly scalable to commercial facilities as they have similar equipment as our commercial manufacturing units.
- All dosage plants are equipped with packaging capabilities (blisters, bottles, pouches, tubes, jars, and vials in cartons), to offer innovative packaging solutions for your products.
- Our Process Development Team is involved in the product development from the early stage development. Team ensures seamless scale up and manufacture of your product.
- The pilot plants in each facility are designed to obtain directly scalable process to commercial scale as the equipment principles on both scales are similar.
- All formulation plants are equipped with packaging capabilities (all types of blisters, HDPE bottles, pouches, vials etc.), to offer innovative packaging solutions for your products.
- Most of our facilities are audited by regulatory agencies like USFDA, MHRA and QP’s. Our manufacturing facilities are spread across geographies to cater your needs.