Orchid Chemicals & Pharmaceuticals' has received Medicines and Healthcare products Regulatory Agency (MHRA) approval for its Betalactam Active Pharmaceutical Ingredient (API) facility at Aurangabad.
"This important regulatory approval received for this state-of-the-art manufacturing facility at Aurangabad is a major milestone for Orchid on several counts" observed K Raghavendra Rao, managing director, of the company.
The MHRA approval is an important step in the overall regulatory road map for and marketing of the Orchid's key betalactam product, Piperacillin - Tazobactam in the lucrative European markets. It also signifies the first major international approval for the Aurangabad API manufacturing complex, which is slated to play a major role in diversification of the Orchid's product range in terms of niche, premium antibiotics and other pharmaceutical products, he further added.
The company would be formulating Piperacillin - Tazobactam in its state-of-the-art dosage form plant at Irungattukottai, Chennai, which is also under the inspection processes. This product is part of the distribution arrangements with two reputed generic partners for the regulated markets of US and Europe.