Granules OmniChem

Granules OmniChem is a 50:50 Joint Venture between Granules India Limited, a well-established Indian based manufacturer of high volume API’s such as paracetamol and ibuprofen and Ajinomoto OmniChem, a Belgium based Contract OmniChem Granules Manufacturing Organization (CMO) for API’s and pharmaceutical Intermediates providing CMO services to its customers with a strong focus on continuous improvement and cost control whilst maintaining quality.

Granules OmniChem is fully supported by Ajinomoto OmniChem for all quality, engineering, tech transfer, EH&S, procurement, sales and management related matters.

The Granules OmniChem site (12,31 acres or 49 000 m2) is located in the Special Economic Zone, Ramky Pharma City, Vizakhapatnam, India which is a whole complex devoted to pharmaceuticals with centralized services.

All procedures (Quality, EH&S etc.) used at Granules OmniChem are drawn up in line with the Ajinomoto OmniChem standards and comply with all local regulations. Multiple bulk manufacturing campaigns of both intermediates and API are expected to trigger inspections of regulatory authorities like US-FDA.

OmniChem Granules

All batch records and documents are in English. R&D, analytical development work and pilot scale campaigns are conducted at Ajinomoto OmniChem Belgium. The technology transfer from Belgium to India is managed by the Ajinomoto OmniChem Project Management staff who provide full technical support. Strict procedures for local IP control are in place.

All commercial activities are covered by the Ajinomoto OmniChem team.

Phase 1 of the investment (approx. 120 m3 capacity ranging from 4000L to 10000L SS & GL reactors) is operational since August 2014.

On the 22nd September 2017 Granules OmniChem Limited (GOC) received the Establishment Inspection Report (EIR) from the US-FDA following the successful on-site inspection that had been carried out over 5 days from the 5th to the 9th December 2016 by 2 US-FDA Investigators. This was a Pre-Approval Inspection (PAI) for a commercial custom manufactured product of a leading pharmaceutical company.

The services / utilities and space will allow a threefold expansion over the coming years.