Orchid Chemicals' facility receives nod from UK regulator
New Delhi, Jan 22 (UNI) Orchid Chemicals&Pharmaceuticals Ltd today said its Betalactam Active Pharmaceutical Ingredient (API) facility in Aurangabad has been approved by the United Kingdom regulator for Medicines and Healthcare products Regulatory Agency (MHRA).
''This important regulatory approval received for the facility at Aurangabad is a major milestone for Orchid on several counts,'' company Managing Director K Raghavendra Rao said.
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 European markets, he said.
He added that 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.
The company would formulate Piperacillin-Tazobactam in its dosage form plant at Irungattukottai, Chennai which is also under the inspection processes.
This product is part of distribution arrangements with two reputed generic partners for the regulated markets of the US and Europe, the company said.
UNI