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APIs (active pharmaceutical ingredients)

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MHRA says quality system deficiencies are most common issue from inspections

20-Nov-2014 - Deficiencies related to manufacturers’ quality systems are by far the most prevalent issue cited from inspections by the UK’s MHRA (Medicines and Healthcare Products Regulatory Agency), the agency said in a report on 2013 inspections .

Do laws hindering umbrella-wielding assassins also hurt Pharma?

19-Nov-2014 - The US Government has asked drugmakers and fine chemicals firms if laws designed to stop the proliferation of chemical weapons are hurting legitimate business.

Dispatches from the Financial Times Global Pharmaceutical and Biotechnology Conference

Pipelines not tax cutting should prompt smaller pharma mergers says AstraZeneca exec

18-Nov-2014 - 2014 has seen record pharma M&A activity but top management of some of the key dealmakers – including Novartis, AstraZeneca and Shire – say size doesn’t always matter.

'Killer experiments' and reimbursement are the keys to VC backing says Index

17-Nov-2014 - Investors only back drug innovators because they have to according to Index Venture Management's Kevin Johnson, who says less risky 'first to be second' firms are much more attractive.

Actavis to acquire Botox maker Allergan for $66bn

17-Nov-2014 - After fending off hostile takeover bids from Valeant for nearly seven months, Allergan is finally agreeing to a takeover, but with Ireland-based Actavis.

Live from London: FT Global Pharma and Biotechnology Conference

17-Nov-2014 -    [View the story "Live from the FT Pharma Conference in London" on Storify]

Big Pharma has improved access to meds since 2012 but marketing practices still a concern says AMF

17-Nov-2014 - Ongoing concerns about marketing practices have taken the shine of a report suggesting Big Pharma efforts have improved parients' access to drugs in developing countries over the past two years.

Indian API manufacturer earns FDA warning letter due to cGMP violations

12-Nov-2014 - Cadila Pharmaceuticals was cited by the US FDA for failing to respond appropriately and to correct issues related to customer complaints.

API shipment delays, New Mexico site issues hamper AMRI Q3 earnings

11-Nov-2014 - Power interruptions and remediation work at AMRI’s Albuquerque, New Mexico facility, as well as unexpected delays to API shipments have driven down the company’s Q3 profits.

Pork Belies: Will traceability regs see China lose dominance of global heparin market?

10-Nov-2014 - Heparin production may be moving back to Europe according to the EFCG, which cited the opening of Pharma Action’s processing plant as an indication that API buyers value quality and compliance throughout the supply chain.

Dispatches from AAPS 2014

BARDA: Ebola is “a bioterrorism threat”

06-Nov-2014 - BARDA, the US government’s Biomedical Advanced Research and Development Authority, has revealed it sees Ebola “as a bioterrorism threat.”

Dispatches from AAPS

Inhaler delivered peptide could prevent LDC deaths during childbirth, says GSK

04-Nov-2014 - Inhaled delivery of the labour inducing peptide oxytocin could help prevent millions of deaths in the lesser-developed countries (LDC), according to a GSK scientist.

Golden spear: a thorn in Big Pharma’s ED business in China?

04-Nov-2014 - A generic version of Viagra launched in China contains the same amount of sildenafil citrate for a fraction of the price according to manufacturer Guangzhou Baiyuanshan Pharmaceutical Holdings (GBPH).

AAPS 2014: Avoiding pharmageddon and pharma innovation discussed in San Diego

03-Nov-2014 -   [View the story "Cali-pharm-ia: Live from AAPS 2014" on Storify]

Warburg Pincus buys 32% stake in Laurus citing ARVs and global opportunities

03-Nov-2014 - Warburg Pincus has bought a 32% stake in Indian API maker Laurus Labs Private Limited citing the ARV drug ingredients market and international opportunities as drivers.

Novartis completes layoffs at Nebraska plant with 44 more departures

03-Nov-2014 - By dropping 44 more employees, Novartis has completed the final phase of the planned restructuring of its once-beleaguered Lincoln, Nebraska manufacturing facility. 

India cuts stability data reqs for API firms seeking docs to ship to EU

30-Oct-2014 - India has relaxed stability data requirements for API manufacturers seeking “written confirmation of quality” certificates needed to ship to the EU.

Novo Nordisk to hire 90 at newly acquired plant in New Hampshire

30-Oct-2014 - Novo Nordisk on Wednesday announced plans to hire up to 90 people at its newly-acquired manufacturing facility in West Lebanon, New Hampshire. 

EDQM sets new policy for testing of bacterial endotoxins

29-Oct-2014 - The European Directorate for the Quality of Medicines & Health Care, under the European Pharmacopeia, has set a new policy for the testing of bacterial endotoxins.

Pharma Action crude heparin plant due to open next week

28-Oct-2014 - A plant being set up by Pharma Action and meat supplier Toennies will produce 15 tonnes of 100% traceable crude heparin a year.

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