Schedule M, WHO GMP and
Facility and Practices
The New Manufacturing Facility of Apogen Remedies Private Limited:

Apogen has been allotted an area of about 4 acres at Genome Valley, Biotech Park Phase III, Karakapatla, for our manufacturing and FR & D activities. The Phase I and Phase II of Genome valley is now the hub of many of the Best National and Multi National Pharmaceutical / Biotech Industries along with ICICI and Alexandria Knowledge Parks. USP also set up their Indian Operations facility in the first phase of genome valley. The Premier Indian National Institute in Pharmacy, NIPER was reserved about Acres 70 of land space for allotment in the same location by APIIC.

Apogen is going ahead with the establishment of a full fledged GMP Compliant Facility for the development and manufacturing of “Ready to Fill Pre-Formulations Intermediates” in the form of IR/EC/SR Pellets & Granules and also the Formulations like Tablets and Capsules of different therapeutic segments. The Facility is so designed to comply with National and International Regulatory Guidelines and GMP requirements to enable us to cater to the diverse needs of our customers from all over the globe with different Regulatory Requirements.

Apogen undertakes its manufacturing operations in Hyderabad City, Andhra Pradesh, India. Driven by breakthrough objectives and continuous thirst for Quality improvement, the company is developing & manufacturing Immediate and Modified Release Pellets of various categories like Delayed Release, Sustained Release, Time Release, Extended Release and Enteric Coated Pellets and DC Granules for customers in India. Apogen aims to export its products around the world in the near future.

Our facility is GMP, ISO 9000-2008 compliant and located in an eco friendly environment. We are able to develop, manufacture & deliver the most STABLE products to our customers by..

Adhering to Good Manufacturing and Documentation Practices
Adopting Qualified Supporting Systems (AHUs, Water, Steam, Drain etc)
Subjecting our Products to Prospective / Concurrent / Retrospective Process Validation in addition to Facility Validation, Computer Systems Validation, Cleaning Procedure Validation and Analytical Method Validation
Practicing Well Maintained Change Control Procedure
Apogen with Un-Compromised Built-in-Quality is competitive with the lowest-cost producers in the domestic as well as global market through a strategic focus on areas such as
Cost-effectiveness and flexibility
Strong knowledge of National & International regulatory guidelines
Identifying and implementing cost-competitive technologies
Reducing costs of materials, supplies and services and cycle time
Optimizing supply chains
The present Apogen manufacturing Facility and Equipment is ideally suited to scale up production to meet any contingent demand or for launching new products without in any way compromising the Product Quality or time lines.

Maintaining Quality Standards Consistently is thus the commitment of our company to meet the National, Regional and International Regulatory Requirements.