The quality of the manufacturing facilities on par with world class standards are playing a vital role in the soaring API business of the two Chennai-based companies-Orchid Chemicals and Shasun Chemicals.

Shasun Chemical and Drugs Ltd has specialized in the manufacture of APIs like ibuprofen, ranitidine, nizatidine, gabapentin, isradepine and methohexital. The APIs are being produced from mainly its Pondicherry and Cudallore facilities.

The 89,000-sq.m Pondicherry facility is dedicated mainly for ibuprofen and derivatives. The API unit, having advanced packing facility and modern effluent treatment plant, is equipped with modern quality control equipment like Malvern, ICP, TOC. The unit is also equipped with state-of-the-art solvent recovery system for Isopropyl Alcohol, Hexane and Acetone.

Shasun's Cudallore facility, spread over 64,000 sq.m, manufactures anti-ulceratives, nizatidine, ranitidine as well as excipients. Equipped with vertically integrated plant, the Cudallore facility is already inspected by EDQM. Approved by various regulatory authorities in addition to being ISO 9001-2000, ISO 14001, OHSAS 18000-certified by BVQI, the facility has different reactor sizes to handle pilot to commercial volumes. The unit is provided with four controlled clean room suits with crystallisers and dryers. It is strengthened with a separate hydrogenation block and utility support capable of a wide vacuum and temperature (-90 to + 200 c) tolerance.

Shasun is selling its quality ingredients in more than 40 countries. During 2004-05, capacity utilization was almost 78 per cent for most products. The company took a shut down in its ibuprofen facility to enable a regulation of supplies in view of rising raw material costs. During the shut down, the company overhauled the facility and automated the packaging section to facilitate the cost effective production of ibuprofen.

Shasun's contract manufacturing activity is growing and during 2004-05 its revenue from CRAMs increased by 18 per cent to Rs 24.50 crore.

The Chennai-based Orchid's two major manufacturing facilities at Alathur (Chennai) and Aurangabad are equipped to produce a wide range of anti-biotic and non-antibiotic APIs, besides certain active nutraceutical ingredients in dedicated facilities.

Orchid's cephalosporin API manufacturing facilities at Alathur are US FDA approved for oral and sterile cephalosporin production. Various products from the facilities have certificates of suitability from European Directorate of Quality for Medicine (EDQM).

Orchid's API complex at Aurangabad is fast developing into a new state-of-the-art hub for bulk drugs production. It has two separate facilities for production of betalactam and non-betalactam APIs. The betalactam facility has been validated for US FDA compliance leading to the planned submission of DMFs this fiscal. During the last quarter of 2004-05, Orchid has also established at Aurangabad a new facility for manufacturing of non-antibiotic APIs, designed for US FDA compliance. The plant, now validated, is engaged in manufacturing of exhibit batches and filing of DMFs for several APIs in the non-penicillin, non-cephalosporin space.