APIs (active pharmaceutical ingredients)

Novo Nordisk’s $40m wastewater plant to be ‘economic driver’ for US state

21-Oct-2019 By Ben Hargreaves

Novo Nordisk completes the construction of a wastewater treatment plant in Clayton, North Carolina, which will be donated to the city to aid biopharma growth.

US FDA recommends Lupin ‘assess its global manufacturing operations’

07-Oct-2019 By Ben Hargreaves

After an investigation last year, the FDA cites problems across multiple sites within the Lupin manufacturing network, raising questions about ‘management oversight and control’.

Gilead's second HIV prevention therapy approved, ahead of generic entry

07-Oct-2019 By Ben Hargreaves

US FDA expands the approval of Gilead’s Descovy to make it available for the PrEP indication, coming ahead of the entrance of generic rivals to the company’s Truvada product.

‘This case is about the color purple’: GSK’s suit against Sandoz refuted

07-Oct-2019 By Ben Hargreaves

England’s High Court throws out the claim that Sandoz’s inhaler product passed off the appearance of GSK’s rival through its use of the color purple in packaging.

The five potential sources of nitrosamine contamination

02-Oct-2019 By Ben Hargreaves

With nitrosamines back in the headlines due to the recent discovery of contaminants in ranitidine, the EMA releases the five potential causes of the impurities plaguing the industry.

Endo ends suit against FDA over compounding case

01-Oct-2019 By Ben Hargreaves

After receiving a favorable outcome against rival compounders, Endo decides to drop its case against the FDA regarding its Vasostrict product.

AstraZeneca divests seven ‘mature’ brands to refocus its portfolio

01-Oct-2019 By Vassia Barba

AstraZeneca enters a $270m deal with Cheplapharm to divest seven drugs, in order to reduce its portfolio of ‘mature’ medicines and reinvest in other therapeutic areas.

Provepharm builds plant to cover its own APIs supply needs

30-Sep-2019 By Vassia Barba

Provepharm expands its facilities in order to manufacture its own active pharmaceutical ingredients, which will be used for molecule revitalization.

AbbVie’s HCV treatment receives first for shorter treatment cycle

30-Sep-2019 By Ben Hargreaves

US FDA granted expanded approval for Mavyret that will allow patients to be treated for the hepatitis C virus in eight weeks.

Eisai and Nichi-Iko extend partnership to target China

30-Sep-2019 By Ben Hargreaves

The Japanese drugmakers will collaborate to sell generic products in China, with the aim of launching ‘one to two products’ every year.

FDA aims to speed naloxone generics to market

27-Sep-2019 By Ben Hargreaves

US FDA follows up the first generic approval of naloxone nasal spray by encouraging companies to apply with generic applications amid the North American opioid crisis.

Ranitidine recalls sweep globe

26-Sep-2019 By Ben Hargreaves

US, Canadian, South Korean, and Indian authorities recommend the recall of certain ranitidine medicines due to cancer-causing impurity.

Sandoz expands recall to include all lots of ranitidine

24-Sep-2019 By Ben Hargreaves

Sandoz has moved to recall all quantities and lots of ranitidine hydrochloride capsules from the US market due to contamination with NDMA.

Europe approves GW Pharma’s CBD medicine

24-Sep-2019 By Ben Hargreaves

Europe joins the US in giving approval to Epidyolex, a CBD treatment for childhood-onset epilepsy.

Torrent expands recall of losartan products, again

23-Sep-2019 By Ben Hargreaves

Torrent announces that it will recall batches of losartan tablets for the sixth time, after the detection of NMBA exceeding acceptable daily intake levels in latest recall.

Novo Nordisk gets nod for oral diabetes drug

23-Sep-2019 By Ben Hargreaves

US FDA provides the first ever approval of an oral GLP-1 treatment to Novo Nordisk, for the treatment of type 2 diabetes.

Darmerica recalls API lots due to label mix-up

19-Sep-2019 By Vassia Barba

Darmerica recalls two lots of product labeled as quinacrine, a compound used as a sclerosing agent, which were instead found to contain a treatment for malaria.

Fears over antacid medicine spark ‘industry-wide recalls’

19-Sep-2019 By Ben Hargreaves

Sandoz announces that it will recall its ranitidine medicine, as part of what a spokesperson said were a series of recalls across the industry.

Future of diabetes care will be about data

18-Sep-2019 By Vassia Barba

Insulin dosing and glucose level monitoring data combined in one platform is the object of two major partnerships focusing on diabetes.

Further NDMA contamination discovery prompts lawsuit

17-Sep-2019 By Ben Hargreaves

Both the FDA and EMA announce NDMA contamination of ranitidine medicines and a lawsuit is immediately filed against manufacturers for ‘concealing’ the carcinogen.

Civica signs supply agreement for medicine, after hospitals ration use

12-Sep-2019 By Ben Hargreaves

Civica agrees a deal with Exela to secure the supply of sodium bicarbonate injections to distribute through its hospital network due to ‘ongoing shortages’.

Mallinckrodt agrees to sell CDMO business for $250m

11-Sep-2019 By Ben Hargreaves

Amid opioid lawsuits, Mallinckrodt looks to slim down its overall business by agreeing the sale of BioVectra to HIG.

UPDATED

FDA delivers warning to Chinese company after no response to Form 483

10-Sep-2019 By Ben Hargreaves

US FDA sends a warning letter to Yino, after the company failed to provide a response to issues raised in a Form 483 regarding relabeling of API.

Mundipharma bets $568m on antifungal treatment

09-Sep-2019 By Ben Hargreaves

Mundipharma signs agreement to progress an antifungal candidate through to commercialization, with the potential for it to become the first approved treatment in 13 years.

Kiel University and Hovione to develop high-dose inhalation formulations

03-Sep-2019 By Vassia Barba

Hovione to work with Kiel University on a dry-powder inhaler, enabling large-dose drug administration under a collaboration agreement.

Shilpa Medicare facility suffers 3 power cuts in 15 minutes, receives Form 483

02-Sep-2019 By Ben Hargreaves

The US FDA issues a Form 483 to Shilpa Medicare, after an investigation noted five observations that require action, including an unreliable power supply.

Analysis finds bulk of warnings delivered to Indian and Chinese drugmakers

30-Aug-2019 By Ben Hargreaves

The US market is dependent upon API and generic drugs produced in India and China, yet these countries also received the majority of warning letters issued by the US FDA.

Ajinomoto acquires JV to integrate its CDMO business

29-Aug-2019 By Vassia Barba

Ajinomoto to acquire remaining interest of its small molecule and API manufacturing joint venture from Granules India.

Licensing agreement formalizes drug delivery technology partnership

29-Aug-2019 By Maggie Lynch

Enteris enters a licensing agreement with Cara Therapeutics for the ongoing development of the latter’s drug candidate as it continues clinical trials.

Pharmaceutical excipients market to hit $9.8bn by 2025

28-Aug-2019 By Vassia Barba

Bolstered by manufacturing advancements, the global revenues of the pharmaceutical excipients market are expected to grow at a CAGR of 5.8% in the coming years.

Roche’s tumour-agnostic drug approved by FDA, priced under competitor drug

19-Aug-2019 By Vassia Barba

Roche receives US FDA approval with two indications for Rozlytrek, prices the drug at almost half of Bayer’s similar drug.

The sartan saga: Recapping the recalls

14-Aug-2019 By Maggie Lynch

After 2018 saw numerous sartan drugs recalled for possible carcinogenic impurities, in 2019, the industry kept an eye on the regulatory issues that followed and the breakthroughs that have mitigated some of the risks.

Urovant ramps up spending on Codexis ingredient ahead of commercial production

13-Aug-2019 By Nick Taylor

Urovant Sciences’ preparations to file for US approval of vibegron add to Codexis’ sales in the second quarter.

Natco Pharma API facility receives Form 483

12-Aug-2019 By Vassia Barba

US FDA issues another Form 483 with six observations to Natco Pharma, noting procedural discrepancies.

Lilly continues to sweep court rulings regarding Alimta patent

12-Aug-2019 By Maggie Lynch

Courts continue to rule in favor of Lilly’s lung cancer treatment patent, as the District Court for Appeals concludes generic producers like Dr Reddy’s to be potentially infringing.

Switzerland upgrades tests to boost detection of sartan impurities

09-Aug-2019 By Nick Taylor

The Swiss Agency for Therapeutic Products revises the test it uses to assess whether sartan medicines are contaminated with nitrosamines.

Reports of deathly errors spark the EMA to order name changes

08-Aug-2019 By Vassia Barba

The EMA demands drug developers to change the name of medicines containing liposomal, following reports of ‘serious medication errors’, some leading to death.

Is ‘lack of control’ in supply chains the root cause of API impurities?

07-Aug-2019 By Maggie Lynch

API recalls have sparked discussion on the development of impurities during manufacturing and the ways in which risks can be mitigated, according to an industry expert.

GSK completes $95m investment for continuous manufacturing in Singapore

06-Aug-2019 By Ben Hargreaves

GSK opens two continuous manufacturing facilities and expands an existing production building to shorten timelines in the production of daprodustat.

FDA issues second Form 483 on Dr Reddy’s India plant

05-Aug-2019 By Vassia Barba

Dr Reddy’s receives a Form 483 with five observations, regarding customer complaints for out-of-specifications results of APIs.

Acquisition of two treatments ‘rounds out’ Upsher-Smiths migraine portfolio

01-Aug-2019 By Maggie Lynch

The acquisition of two migraine therapies from Dr Reddy’s has been completed by Upsher-Smith, adding different drug delivery treatment options to its migraine product portfolio.

July roundup: Regulators experience a busy month

31-Jul-2019 By Ben Hargreaves

July has seen a number of actions taken by regulators to manage the supply of medicine, including a crackdown on CBD manufacturers and repackers of opioid medication.

FDA aims high in crackdown on CBD manufacturers

24-Jul-2019 By Ben Hargreaves

US FDA took aim at the ‘world’s largest' cannabis company for making ‘unfounded claims’ about the therapeutic potential of its CBD products.

FDA greenlights nine Lyrica generics

23-Jul-2019 By Vassia Barba

Nine companies, including Teva, Alembic and Amneal receive US FDA approval for generic versions of Pfizer’s blockbuster Lyrica.

Biohaven’s application rejected due to Apotex manufacturing issues

22-Jul-2019 By Ben Hargreaves

Biohaven’s sublingual Riluzole treatment for ALS receives a CRL from the US FDA due to the API being supplied by Apotex.

Warning letter and Form 483 received by Indoco made public

16-Jul-2019 By Ben Hargreaves

Indoco confirms receipt of a warning letter from the US FDA and the agency posts details of a Form 483 for two different facilities in the space of one week.

LGM expands its services for section 503B APIs

15-Jul-2019 By Vassia Barba

LGM expands its service offerings to further support companies that supply APIs to compounding pharmacies under the FDA’s 503B section.

Gilead and Lyndra co-develop long-acting HIV therapies

11-Jul-2019 By Vassia Barba

Following Gilead’s funding of Lyndra’s technology, the latter company offers exclusive rights to its therapeutics platform for long-acting HIV therapies formulations.