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APIs (active pharmaceutical ingredients)

News headlines

Ipca halts API shipments to US following 483 at Indian plant

24-Jul-2014 - Ipca Laboratories has halted shipments to the US of active pharmaceutical ingredients (APIs) made from a facility in India following a US FDA inspection.

Onyx contracted for API R&D and manufacturing by UK cancer charity

23-Jul-2014 - Onyx Scientific has been contracted to develop and manufacture APIs for clinical trials by charitable group Cancer Research UK.

Lilly swaps dry powders for insulin at Indiana site in post-patent shake-up

23-Jul-2014 - Patent expiration and a large molecule pipeline has prompted Eli Lilly to repurpose a solid oral dose plant in Indiana.

ADHD API sales up, specialty opiates down at Johnson Matthey in Q1

23-Jul-2014 - Johnson Matthey’s API business had a mixed fiscal Q1 with gains made in ADHD ingredients and bulk opiates being accompanied by a decline in revenue from specialty opiates.

Drug ingredients were key to Ireland's manufacturing growth in 2013 says CSO

21-Jul-2014 - Basic pharmaceuticals including APIs became even more important revenue generators for Ireland in 2013 according to new data released by the Central Statistics Office (CSO).

Glenmark to build first US manufacturing plant

21-Jul-2014 - India-based Glenmark Pharmaceuticals has announced plans to set up a new oral solid dosage manufacturing facility in North Carolina. 

Janssen's tramadol supply chain ready for DEA's rescheduling deadline

16-Jul-2014 - Janssen Pharmaceuticals is prepared for Tramadol's reclassification by the US Drug Enforcement Administration (DEA) and says the supply of its versions of the opioid analgesic will not be interrupted.

Italian API manufacturer hit with FDA warning letter over data control

16-Jul-2014 - Cited with data quality issues, Italian API manufacturer Trifarma has until July 24 to respond to a litany of requests from the US FDA.

Codexis: $25m GSK tech accord could be catalyst for more Big Pharma deals

15-Jul-2014 - Biocatalyst developer Codexis says its new platform licensing deal with GSK is a model with which it can approach other Big Pharma firms.

Pfizer: Unexpected hike in volumes of post-patent drugs saves Irish jobs

11-Jul-2014 - Pfizer says 100 workers at an Irish facility will now keep their jobs due to an unpredicted increase in production volumes of off-patent drugs.

Waters to open laboratory with Chinese Pharmacopoeia

10-Jul-2014 - Pharma technology provider Waters as agreed with the Chinese Pharmacopoeia Commission (ChP) to establish a joint open laboratory to develop new pharmacopoeia standards.

GRAS always greener? FDA considers overhauling OTC monograph system

09-Jul-2014 - The US FDA has given stakeholders more time to comment on the 40-year old monograph system used to regulate OTC drugs and reiterated its concerns that the approach does not allow it to keep up with new drug safety testing advances. 

Indian firms must invest in compliance as USFDA ups enforcement, says S&P

09-Jul-2014 - Indian drugmakers must invest heavily in compliance processes in response to the US FDA’s “aggressive surveillance” and inspection programme, a Standard & Poor report has said.

Apotex hit with warning letter on troubled API facility in India

09-Jul-2014 - Apotex is getting reprimanded once again for its API facility in Bangalore, India, after the company failed to adequately respond to an FDA Form 483 over data integrity issues, according to an FDA warning letter dated June 16 .

Merck Millipore says Indian lab can boost generics quality

07-Jul-2014 - Merck Millipore, the life sciences tools division of Merck KGaA, has launched a solid dose formulation lab in India, its first outside Europe.

News in brief

Aarti Drugs considers formulations driven plant acqusition

07-Jul-2014 - Aarti Drugs has said it is considering buying an unnamed manufacturer in Himachal Pradesh, India to expand its drug formulations business

Hospira finally completes Orchid plant acquisition

07-Jul-2014 - Hospira has paid Orchid Chemicals and Pharmaceuticals $218m (€160m) for an API plant in Aurangabad, India to increase its antibiotics production capacity and cut reliance on external suppliers.

Bulk ingredient prices skyrocket in US as payers clamp down

03-Jul-2014 - Bulk pharmaceutical ingredients increasingly used by compounding pharmacies have seen astronomical price hikes over the past two years and now payers are catching on to the trend and stepping in.

News in brief

Medichem opens Malta HPAPI plant

01-Jul-2014 - Medichem has opened an API plant in Malta touting the country’s “unique patent situation” as an attractive option for generic drugmakers.

Onyx invests in continuous flow following API demand

01-Jul-2014 - UK API-maker and contract research organisation (CRO) Onyx Scientific is installing equipment for continuous flow manufacturing to offer customers an alternative to batch manufacturing.

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