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APIs (active pharmaceutical ingredients)

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Divi's Labs' Vizag plant banned from shipping to US

23-Mar-2017 - Indian API firm Divi’s Laboratories has been banned from shipping drug ingredients made at its Vizag plant to the US.

update with comment from FDA

US FDA criticizes Indian drug firm USV for problems at multiple sites

22-Mar-2017 - The US FDA has called on Indian drug firm USV Private Limited to rethink how its tests for microbial contamination at its manufacturing facilities.

US FDA says Jinan Jinda Pharma must do more make Shandong plant compliant

22-Mar-2017 - Jinan Jinda Pharmaceutical Chemistry Co. Ltd has more to do to bring its drug ingredient plant in Shandong, China up to code according to the US FDA.

Patheon ramping up former Roche site to fulfil demand for Western APIs

20-Mar-2017 - Patheon believes it can triple revenues at its recently acquired Roche facility in South Carolina due to a shortage of Western active pharmaceutical ingredient (API) capacity.

Cannabinoid-based chewing gum enrolls patients in Ph II trial

16-Mar-2017 - Axim Biotech has enrolled patients in its Phase II trial for Canchew Plus chewing gum – a delivery method with a “cumulative effect,” says CEO.

US FDA says Badrivishal can't ensure safety of river water used at API plant

16-Mar-2017 - The US FDA has criticised Badrivishal Chemicals & Pharmaceuticals for failing to document production and monitor the efficacy of water purification systems at its API plant in Maharashtra.  

Misbranded epilepsy drug API lands FDA warning for Chinese ingredient maker

15-Mar-2017 - The US FDA has slammed China’s Lumis Global Pharmaceuticals for problems documenting and labelling active pharmaceutical ingredients.

DSM Sinochem licenses enzymatic antibiotic production tech to Sandoz; sues Weiqida

15-Mar-2017 - DSM Sinochem Pharmaceuticals has licensed enzyme-based antibiotic production IP to Sandoz and accused Sinopharm Weiqida Pharmaceutical of patent infringement.

Siegfried’s revenues up on APIs and new plants, earnings down on costs

14-Mar-2017 - Siegfried saw higher sales in 2016 thanks to the API business it bought from BASF and opening of new plant in China, but profits fell on integration costs and higher taxes.

Re-inspection lands Dr Reddy’s Form 483 with 13 observations at Duvvada plant

09-Mar-2017 - Dr Reddy’s Laboratories says it is addressing the observations at its Duvvada plant which was hit with a warning letter in 2015.

US FDA slams second Megafine facility in India with warning letter

08-Mar-2017 - A second Megafine Pharma plant has landed a US FDA warning letter for cGMP violations, including sourcing API intermediate materials from a facility on import alert.

Opioid API firm Noramco moves into cannabinoids

08-Mar-2017 - Noramco has added cannabinoids to its portfolio of opioid APIs.

Noramco planning formulation tech unit alongside opioid API business

07-Mar-2017 - Former J&J controlled substance API unit Noramco is to rejig its business to cater for branded and generic drug firms and companies looking for formulation tech solutions.

US FDA says Wockhardt's oversight of drug production inadequate

07-Mar-2017 - The US FDA has told Wockhardt its quality issues are company-wide, citing problems at subsidiary Morton Grove as an example in a warning letter published today.

Keryx: Patheon and Norwich sites will ensure supply of iron-based Auryxia

06-Mar-2017 - Keryx Biopharmaceuticals will continue to work with Norwich Pharmaceuticals despite bringing Patheon on board to manufacture Auryxia (ferric citrate).

US Wockhardt subsidiary Morton Grove warned by US FDA

06-Mar-2017 - The US FDA has warned Wockhardt Limited about operations at its US subsidiary Morton Grove Pharmaceuticals Inc. 

update

EU and US agree to share API and drug plant inspection data

02-Mar-2017 - The EU and US have agreed to recognize drug and API manufacturing plant inspections conducted in their respective territories under a deal signed this week.

US FDA clears Akorn's generic CellCept after Form 483 resolved

02-Mar-2017 - The US FDA has cleared Akorn Inc. to sell a generic version of the immunosuppressant CellCept made at its plant in Decatur, Illinois.

Turmeric bioavailability enhancer could be used with APIs, Wacker

02-Mar-2017 - Wacker Biosolutions says an excipient shown to increase the bioavailability of a food supplement by a factor of 40 could have implications in the API space.

update - Fosun to relocate production

Fosun-owned API maker Chongqing criticized by US FDA

01-Mar-2017 - Lab staff at an API plant run by Chongqing Pharma Research Institute Co., Ltd. deleted out of spec test results according to the US Food and Drug Administration (FDA).

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