The company has completed the pre approval inspection (PAI) for an active pharmaceutical ingredient (API) manufactured at its Units 1&3, located at Visakhapatnam by the United States Food and Drug Administration, Laurus Labs said in a filing to the BSE. The inspection was completed with three observations, 'which are procedural in nature'.
The company which won the tender to market Olanzapine drug in China, is expected to launch it beginning next year, the official said. The products are manufactured either in the plant owned by KRRP in China, or partners in China, or in India by Dr. Reddy's, the official further said.
Malvinder’s lawyer Manu Sharma today approached the court with a plea that there has been no headway in the case filed in February. Malvinder had accused that his brother Shivinder, the family members of Dhillon had misappropriated the funds of RHC Holding, the company that owned assets of the group and had sought Rs 8,742 crore in compensation.
The USFDA has approved to market Isosorbide Dinitrate tablets manufactured by drug firm Zydus Cadila. The drug firm has also received final approval from US health regulator for Desonide Cream, used to treat a variety of skin conditions like eczema, dermatitis, allergies and rash, the company said in a filing to BSE.
The Department of Pharmaceuticals along with the Drug pricing regulator, National Pharmaceutical Pricing Authority (NPPA) will discuss the issue of TMR with the stakeholders, in an effort to reduce prices of medicines & medical devices. The trade margin is the difference between the price at which the manufacturers/importers sell to stockists and the price charged to consumers.
Susheel Umesh brings in 27 years of experience, deep understanding of pharmaceutical industry, the company said. Panacea Biotec is a leading pharmaceutical and biotechnology company with established research, manufacturing and marketing capabilities.
Special Judge extended the ED custody of both Malvinder Singh and former CMD of Religare Enterprises Ltd Sunil Godhwani till November 23 on a plea moved by agency's special public prosecutor Nitesh Rana. The ED had taken both the accused in its custody on November 14 inside the jail, where they were lodged in a case filed by the Delhi Police in relation to the alleged scam.
GV Prasad, Chairman, CII National Committee on Pharmaceuticals said that everybody should up their game in terms of quality, systems, discipline, integrity of data. All there are important things for the industry. He added that the effect of frequent inspections of Indian pharma manufacturing plants by the FDA and measures to be taken to reduce the impact.
In a warning letter issued to the company's CEO Heather Bresch, the US Food and Drug Administration (USFDA) said inspectors during May 27 to June 5, this year found significant deviations from standard manufacturing practices at the company's Unit 8 in G Chodavaram village in Vizianagaram.
Illegal import of drugs from Bangladesh and other neighbouring countries have further added to the woes of pharmaceutical companies. Experts suggest a thriving ‘grey’ market of fake and unapproved copies of Big Pharma’s oncology and hepatology medicines, and some under patent protection. The drugs are smuggled, hence exact numbers are unavailable.
The Supreme Court Friday held former Ranbaxy promoters Malvinder and Shivinder Singh guilty of contempt for violating its order that had asked them not to divest their shares in Fortis Healthcare Limited. The apex court had earlier asked the Singh brothers to give it a plan as to how they would honour the arbitral award of Rs 3,500 crore granted by a Singapore tribunal against them, in favour of Japanese drug manufacturer Daiichi Sankyo. ET's Teena Thacker has more. (Text: PTI)
A bench comprising Chief Justice Ranjan Gogoi and Justice Deepak Gupta held the former Ranbaxy promoters guilty of contempt of court and said that they had violated its earlier order by which the sale of their controlling stakes in Fortis Group to Malayasian firm IHH Healthcare was put on hold.
The Supreme Court on Friday held former Ranbaxy promoters Malvinder Singh and Shivinder Singh guilty of contempt of court for violating its order asking them not to divest their shares in Fortis Healthcare Limited. The apex curt had earlier asked the Singh brothers to give it a plan as to how they would honour the arbitral award of Rs 3,500 crore granted by a Singapore tribunal against them and in favour of Japanese drug manufacturer Daiichi Sankyo.
According to a 74 page affidavit filed in the High Court, chief of Radha Soami Satsang Beas (RSSB) Gurinder Singh Dhillon has said that in 2010, RHC holdings Ltd (respondent 19) through Singh brothers had approached him to assist them in subscribing for the rights issue, suggesting that they would finance Dhillons to subscribe to the rights issue.
“In our ongoing commitment to address the supply shortages of rabies vaccine, we are making additional investments to increase production capacities to over 15 million doses annually,” added Krishna Ella, CMD, Bharat biotech International Ltd. The vaccine is presently manufactured at the WHO pre-qualified facility in Ankleshwar in Gujarat.
Biocon, the Bengaluru-headquartered bio-pharma firm and the parent company for Biocon Biologics, has has been recognised as the ASIA IP ELITE for the fourth year in a row. Biocon’s subsidiary received this award at the recently concluded IP Business Congress Asia in Tokyo, Japan. Biocon Biologics has a product pipeline of 28 molecules.