If the company manages to get a go-ahead from the regulator for this plant, it might result in resumption of supplies of several of their products, barred from the US last year.
Roadblocks ahead as these medicines could face new clinical tests, more scrutiny
The move assumes significance because a go-ahead from the US Food and Drug Administration for the new unit in Visakhapatnam is likely to give a huge boost to the company's revenues in upcoming quarters.
Various domestic companies such as Ranbaxy, Wockhardt and Agila Specialities recently came under the US FDA scanner for lapse in manufacturing practices.
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The Drugs Controller General of India is considering the recommendations of its advisory body to revoke the suspension of the sale of analgin-based medicines in the country.
Move follows a spate of international regulatory enforcements on Indian drug firms.
Importers protest as food safety regulator demands adherence to recent law on labelling, blocks entry at ports for packs with stickers.
Govt wants firms to remove suffixes & prefixes to original names of these drugs.
The Indian Pharmaceutical Alliance has approached regulator for a dialogue to understand the concern raised by it
Say heavy penalties for medical errors might raise health care costs and make practitioners too cautious, says Sushmi Dey
As many as 150 applications are stuck at evaluation stage, says official.
Ranbaxy's US factory, Ohm Laboratories, is learnt to have got a clean chit from the American regulator. This US facility was under surveillance of the Food and Drug Administration (FDA) since the end of 2012.
Happy hours, a discount concept popular across bars, restaurants and multiplexes, is now catching up in the health care sector, too.
The country's drug companies have attracted the highest number of enforcements from the American drug regulator in 2013, a year that has seen the US Food and Drug Administration turning stricter to ensure compliance levels and quality of medicines.
DCGI, health ministry initiate dialogues with foreign regulators, try to understand global best practices
The move comes in the wake of many facilities of Ranbaxy in India being barred by the US Food and Drugs Administration for supplying medicines to the US.
Import alert on Ranbaxy's Mohali unit; Strides' injectible arm gets warning letter
Medicines, including antibiotics, contraceptives and anti-diabetic drugs, were found to be out of stock at various places around Delhi.
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According to sources, the company has identified smaller markets such as Peru, which do not contribute significantly to profits, where it might shut shop in the near term.
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Firms are mandated to change prices of medicines within 45 days of NPPA's notification.
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