Pharma manufacturing news in brief
pharmafile | September 17, 2012 | News story | Manufacturing and Production |Â Â Ampio, DPT Labs, Ethypharm, ICH, PC Pharma, RanbaxyÂ
Ranbaxy and PC Pharma unveil new facility investments, Ethypharm will manufacture Ampio drug, DPT Labs is warned by the FDA and ICH looks into an update of its Q7 standard.
India’s Ranbaxy Laboratories has been given a green light by the government of Malaysia to start construction of a manufacturing facility with a planned investment of around $40 million. The plant will be Ranbaxy’s second in Malaysia and once completed will employ around 200 people. It will manufacture solid oral dosage forms – primarily in the cardiovascular, antidiabetic, anti-infective and gastrointestinal categories – and once fully operational will increase Ranbaxy’s production capacity in Malaysia from 1 billion to 3 billion doses a year. The plant will supply the national drug market as well as export products to other countries.
Ampio Pharmaceuticals has signed an agreement with French company Ethypharm for the manufacture of Zertane (tramadol), its drug candidate for preventing premature ejaculation. Ampio has already tapped Ethypham’s expertise to develop an orally disintegrating tablet (ODT) formulation of Zertane which has progressed through Phase III testing in Europe. If approved, Zertane would compete with Janssen’s Priligy (dapoxetine), the only approved systemic drug for premature ejaculation.
US firm DPT Laboratories – which was recently acquired by private equity group Renaissance Acquisition Holdings – has been sent a warning letter by the FDA over sterility failures and inadequate investigation of quality problems at its manufacturing facility in Lakewood, New Jersey. The letter – dated 27 August – cites microbial contamination of six lots of Santyl (collagenase) ointment with a bacillus species and asks DPT to submit a detailed evaluation of its cleaning and disinfection programme as well as remediation plans. Santyl is used to remove dead, necrotic tissue from wounds.
Sri Lankan medicine importer and distributor PC Pharma is planning a move into drug manufacturing with the help of joint venture with Bangladeshi drugmaker Square Pharmaceuticals and an as-yet unidentified Indian partner. PC Pharma’s chief executive Dilshad Ikram said the JV partners would set up a manufacturing facility that is expected to be brought online during 2013, according to a report in The Nation newspaper. PC Pharma is already a distributor in Sri Lanka for Square Pharmaceuticals’ branded generic products.
The International Conference on Harmonization (ICH) is considering a revision of its 12-year-old Q7 guidelines on good manufacturing practices (GMP) for active pharmaceutical ingredients (API), according to an FDA official cited by Drug GMP report. Robert Yetter, associate director for review management at the FDA’s Centre for Biologics Evaluation and Research (CBER), said that an informal working group had been set up to look into bringing the ‘dated’ standard into line with current requirements.
Phil Taylor
Related Content
US FDA offers plan for global regulatory harmonisation for generic drugs
The US Food and Drug Administration (FDA) is offering a proposal to the International Council …
Sun Pharma inaugurates first Egypt production facility
Ranbaxy, a subsidiary of India’s Sun Pharma, has opened its first production facility in Egypt …
Daiichi pulls out of India with closure of 170-strong R&D plant
Japanese pharma firm Daiichi Sankyo has announced its intention to close its R&D centre in …
