Formulation Manufacturing Complex - Irungattukottai (Chennai)

Orchid’s world class formulations manufacturing complex located in Irungattukottai (IKKT), near Chennai has modern R&D and manufacturing facilities. The formulations infrastructure is in the forefront of Orchid’s successful entry into the advanced markets of US and Europe. The manufacturing complex employing over 400 scientists, technologists and other professionals has independent manufacturing blocks for cephalosporins, penicillin injectables (high-end betalactams), carbapenems and non-penicillin, non-cephalosporin (NPNC) products.

Located in a site area of about 30 acres, Orchid’s Formulations Complex has facilities for manufacturing various types of dosage forms such as sterile dry powder vials, oral tablets, capsules and dry syrup bottles in several product categories.

The complex is inspected and approved by leading regulatory agencies including the US FDA and UK MHRA, based on specific filings. Several ANDAs have been filed from this complex with approvals and subsequent launches continuously underway.

The Formulations Complex houses a modern R&D Centre for pharmaceuticals research, with a built-up area of 2000 square meters, set in an adjacent plot of about 6 acres. The R&D Centre has sophisticated analytical instrumentation for pharmaceutical research such as HPLCs, LCMS-MS, DSC, GC, TOC Analyser and Ion Chromatographer besides laboratory scale equipment for pharmaceutical development and manufacturing. The pharma R&D Centre undertakes development and filing of Abbreviated New Drug Applications (ANDAs) and research on Novel Drug Delivery Systems (NDDS).

Cephalosporin Formulations (Generics)

Orchid's state-of-the-art US FDA and UK MHRA approved cephalosporin antibiotic formulations facility is designed to manufacture a range of oral and sterile cephalosporins.

Aimed at the advanced markets of US, Europe and Japan, the facility set in a sprawling site, has sophisticated equipment designed for high throughput, stringent systems and processes tuned for regulatory compliance together with a high performance team.

The sterile cephalosporins facility has modern automated equipment for sterilization of all components and for sterile vial filling under stringent atmospheric class conditions. The oral solid dosage form facility has high throughput machines with automated controls for consistent quality and productivity.

The Betalactam Facility (Penicillin injectables)

The vial lyophilization facility for manufacture of betalactum antibiotics is the latest addition to the infrastructural base in the Formulations Complex. Orchid’s betalactam product range includes high-end betalactams like Tazobactam+Piperacillin, Aztreonam and Ampicillin+Sulbactam injections which are important life saving antibiotics used in the treatment of a wide variety of infections. The facility has a built up area of 4200 square meters and is capable of producing high volume of products.

Orchid is the only manufacturer of Tazobactam+Piperacillin in the world (apart from MNCs) on an end-to-end basis, from API to the final finished dosage form and in a US FDA compliant environment. The Tazobactam+Piperacillin API, which are manufactured at Orchid’s API plant in Aurangabad are dissolved into Tazobactam+Piperacillin mixture and lyophilized in vials as dry powder injections in the betalactam formulations facility at Irungattukottai (Chennai) under sterile conditions. Lyophillization is a process by which the product is freeze-dried through a series of unique processes to remove moisture from the product, without affecting its biological, chemical or structured properties while maintaining product purity and integrity.

In-situ sterile lyophillization of vials is a complex and technologically challenging manufacturing process which ensures the highest levels of consistency and quality of this premium injectable product. There is no facility other than Orchid’s (besides the innovator’s) for manufacturing this product using this process.

In Orchid’s vial lyophilization facility, the entire process of manufacture is automated, covering transfer of vials from the warehouse, vial washing, vial filling, vial lyophilization, vial capping and secondary packing. The design of filling equipment is unique in that both liquid filling and dry powder filling can be carried out on the same line. Loading and unloading of the vials into the lyophilizer is carried out through an automatic loading system. The vial lyophilizer, a massive equipment with a shelf area of 43 square meters and an ice condensor capacity of 800 litres has been custom-developed based on Orchid’s needs and designs. The equipment has unique features like automatic cleaning-in-process and sterilization-in-process cycles as well as online automatic weight checking. The secondary packing lines are also fully integrated and automated, with on-line inspection and security. The systems for water for injection and purified water are also fully automated.

The overall facility and building design ensures the highest standards of aseptic manufacture, in compliance with the relevant Good Manufacturing Practices (GMP). As the operations move towards aseptic zones, the class areas become more stringent, ranging from class 10,000 environment in preparation areas (eg., vial washing area) to class 1000 environment in sterile environment areas (eg., product filling room, capping room) and to class 100 laminar air flow environment at the point of fill for sterile products and transfer of sterile filled vials to lyophilizer and from the lyophilizer to capping machines.

The design of the building with dedicated HVAC systems and stringent controls on personnel and material movements are developed to avoid any cross-contamination of areas. Appropriate measures are taken to ensure that the product is contained within the building and particles do not escape to the external environment. The design incorporates, for this purpose, HEPA filters on air discharged to the external atmosphere and air locks where materials exit and enter, besides garment change protocols for personnel on entry and exit.

Orchid’s new sterile betalactam dosage form facility thus represents the most advanced sterile pharmaceutical manufacturing technology, comparable with the best in the world. The facility would be a further reinforcement of Orchid’s and India’s technical competencies in the global pharmaceutical industry.