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Headlines > All Ingredients News

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.

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.

Nicox resubmits AC-170 NDA after API supplier resolves GMP issues

09-Mar-2017 - Nicox S.A. has resubmitted AC-170, its conjunctivitis associated itching drug candidate, for US FDA review after its API supplier resolved the problems that saw the agency reject the New Drug Application (NDA) last year.

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.

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).

GSK seeks advice on planned Scottish respiratory API plant

28-Feb-2017 - GSK has asked Angus Council for advice as it prepares to submit a planning application for an API plant it intends to build at its site in Montrose, Scotland.

Dr. Reddy's' Miryalaguda plant issued with Form 483 after US FDA audit

23-Feb-2017 - Dr Reddy’s Laboratories has been issued with a Form 483 after an inspection at its active pharmaceutical ingredient (API) plant in Miryalaguda in Telangana, India.

Biolabex's Mauritius R&D lab open for business

23-Feb-2017 - Biolabex has opened a manufacturing and R&D laboratory at BioPark Mauritius, a biohub in Vacoas-Phoenix south of the capital Port Louis.

AmpTec looking to achieve full GMP compliance for APIs

21-Feb-2017 - AmpTec GmbH is in the process of achieving full GMP compliance for API manufacturers in order to expand its offerings into the clinical space.

Granules to expand Indian API plants and US dosage form site

21-Feb-2017 - Granules India will build an API production facility in Bonthapally, Telangana and expand other manufacturing sites in a project backed by the Word Bank. 

CMOs need to increase awareness of offerings, ISR reports

20-Feb-2017 - A "new set of leaders" emerged in the contract manufacturing organization (CMO) industry over the past year, though many remain unheard of, according to a recent report .

Teva sees higher active pharmaceutical ingredient sales in 2016

15-Feb-2017 - Copaxone maker Teva Pharmaceutical Industries Ltd. saw higher active pharmaceutical ingredient (API) sales last year.

News in brief

Sun Pharmaceutical Industries sees API sales slide in Q3

15-Feb-2017 - Sun Pharmaceutical Industries Ltd. saw lower active pharmaceutical ingredient (API) revenue in the third quarter of fiscal 2017.

Stada confirms €3.5bn bid from Cinven and interest from Advent

14-Feb-2017 - API manufacturer Stada Arzeneimittel AG has received an acquisition offer from private equity firm Cinven Ltd., and an expression of interest from Advent International Corp.

Indian API maker slammed by US FDA for water and cleaning issues

14-Feb-2017 - The US FDA has issued a warning letter to Indian API maker Resonance Laboratories Private Limited citing inadequate cleaning procedures at its facility in Bangalore.

Pfizer to shut Australian Neulasta biosimilar plant and move production to Croatia

10-Feb-2017 - Pfizer will close the Australian plant which produces the API for HSP-130, a candidate version of Amgen’s Neulasta, and shift production to Croatia.

India to allow API firms to request EU quality confirmations online

09-Feb-2017 - Indian regulators will allow API firms to seek the confirmations needed to ship to the EU online from next month.

Pot luck? Medical marijuana's 'questionable quality’ no threat to pharma R&D

08-Feb-2017 - Pharma firms using cannabis-derived ingredients have hit out at the lack of standardization and the questionable quality of medical marijuana.

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