APIs (active pharmaceutical ingredients)

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.

‘Removing the need for other partners’: Onyx invests in commercial API license

11-Jul-2019 By Maggie Lynch

Onyx invests in a commercial API license and expands its UK facility to bolster its manufacturing capabilities for niche, small-scale production.

FDA warns repackers for cGMP violations on opioids

08-Jul-2019 By Vassia Barba

B&B, Asclemed and Spectrum receive warnings from the FDA regarding issues in the supply chain of APIs that ‘pose a real threat to public health’.

ANI launches generic ranitidine capsules for duodenal ulcer

01-Jul-2019 By Vassia Barba

ANI Pharmaceuticals proceeds to commercialization of ranitidine capsules for the treatment of duodenal ulcer, through a partnership with Appco Pharma.

Akorn takes on second FDA warning letter with companywide action plan

01-Jul-2019 By Maggie Lynch

Akorn received a warning letter from US FDA after an inspection at its Somerset, New Jersey manufacturing facility in July and August of 2018.

Novartis rejects suggestion of supplying chemicals to Syria

28-Jun-2019 By Vassia Barba

Novartis says it did not export substances potentially used as chemical weapons to Syria, distancing itself from Brenntag exports.

Piramal expands high potency API facility in Michigan

27-Jun-2019 By Vassia Barba

Piramal’s $10m expansion at its site in Michigan supports ‘dramatic growth’ and ‘brings more to the table’.

AMPAC re-opens 50,000 gallon API facility in Virginia

24-Jun-2019 By Maggie Lynch

After being acquired by SK Holdings, AMPAC re-opens its API manufacturing facility in Virginia as part of a growing investment in its US capabilities.

Pharmacy detects ‘high levels’ of new carcinogen in valsartan batches

20-Jun-2019 By Ben Hargreaves

Valisure detects fourth probable carcinogen in valsartan medication and criticises the US FDA’s daily exposure limits as lacking a ‘rational basis’ and being ‘of significant concern’.

Dr Reddy’s in 'timely divestiture' of neurology products for $110m

18-Jun-2019 By Ben Hargreaves

Dr Reddy’s enters asset purchase agreement with Upsher-Smith to sell rights for its neurology products, Zembrace and Tosymra.

Boehringer opens €120m facility to meet half of global demand for Respimat

18-Jun-2019 By Ben Hargreaves

Boehringer’s plant opens in Barcelona and will produce 25m units per year of Respimat to be distributed to more than 100 countries.

NEWS IN BRIEF

Paracetamol batches recalled after fungal contamination

18-Jun-2019 By Ben Hargreaves

The MHRA announces recall of paracetamol tablets, after certain products were found to be discoloured due to the presence of fungi.

Lonza’s Swiss site adds HPAPI manufacturing capacity after AZ deal

17-Jun-2019 By Maggie Lynch

Lonza expands its HPAPI production capacity at its Switzerland facility after entering an agreement with AstraZeneca, and invests in manufacturing to establish efficiency.

Plant explosion kills three in India

11-Jun-2019 By Ben Hargreaves

An Indo-Chinese pharma company saw three workers die after the explosion of an oven that was under repair.

Cambrex completes $11m labs and logistics center expansion

11-Jun-2019 By Vassia Barba

Cambrex announces the completion of a 600-square-meter facility in Karlskoga, Sweden, alongside a 3,000-square-meter warehouse.

Athenex suspends Chinese API production after safety concerns

10-Jun-2019 By Ben Hargreaves

Athenex announces the voluntarily suspension of production activities, following several incidents at chemical factories across China,

NEWS IN BRIEF

Otsuka enters the API business after Astellas asset acquisition

10-Jun-2019 By Ben Hargreaves

Otsuka acquires Astellas’ Cefixime business, which means it will supply the API to overseas licensees and thereby enter the API business.

Sterling Pharma pilot plant operational after $7.6m investment

06-Jun-2019 By Maggie Lynch

Scale-up capabilities and increased capacity seen after Sterling Pharma’s pilot plant becomes operational after $7.6m investment.

Lonza to carve-out and trim down Specialty Ingredients business

03-Jun-2019 By Ben Hargreaves

Lonza announces that its Specialty Ingredients business will operate independently by ‘mid-2020’ and will cut away approximately 130 roles at the same time.

EMA puts spotlight on antimicrobial resistance as river contamination spreads

30-May-2019 By Vassia Barba

EMA assembles pharmaceutical developers to strengthen antimicrobial pipelines while, in the meantime, a study found the world’s rivers dangerously contaminated.

Heritage issues recall after products contaminated with ‘microbial growth’

27-May-2019 By Ben Hargreaves

Heritage announces a recall of lots of amikacin sulfate injection and prochlorperazine edisylate injection, due to evidence of selected products being non-sterile.

Lupin receives Form 483 after product contaminated with human hair

23-May-2019 By Ben Hargreaves

US FDA issues Lupin with a Form 483 based on three observations during a recent inspection at its Aurangabad site.

Thermo Fisher’s M&A spend continues with €90m GSK facility

16-May-2019 By Ben Hargreaves

Thermo Fisher announces an agreement that will see it acquire GSK’s Cork manufacturing site.

‘Speed and efficiency’: WuXi STA outlines benefits of integrated CMC services

15-May-2019 By Ben Hargreaves

As WuXi STA expands its facility footprint in China, a VP of the company explains how global regulatory approvals fit with strategic plans for services to be concentrated geographically.

Tension over generic entry sees Gilead donating 2.4m bottles of PrEP

14-May-2019 By Maggie Lynch

As generic competition looms, Gilead donates 2.4 million bottles of Truvada to the CDC to aid in the center’s fight against the HIV epidemic in the US.

Takeda divests eye product to Novartis for $5.3bn

09-May-2019 By Ben Hargreaves

Takeda begins the process of divesting products to make its purchase of Shire viable, with $5.7bn worth of assets heading out of the door.

Second CRL given to Acacia after ‘continuing deficiencies’

07-May-2019 By Maggie Lynch

Acacia Pharma receives a second CRL from the US FDA regarding its NDA, after GMP deficiencies during API production were revealed again.

Lundbeck set to add Abide’s chemo-proteomic platform for $400m

06-May-2019 By Ben Hargreaves

Lundbeck announces the acquisition of Abide, which provides the former with access to an R&D platform, a Phase II drug candidate, and drug discovery site in California.

Torrent hit with two plant observations in three weeks

06-May-2019 By Ben Hargreaves

The Indian company announced that the US FDA issued observations for both its Indrad and Dahej facilities, as well as being required to expand its losartan recall.

Over 100 lots of losartan tablets recalled after NMBA detected

29-Apr-2019 By Maggie Lynch

Teva begins recall in the US of 35 lots of losartan tablets and Torrent expands its recall to include an additional 104 lots, after trace amounts of NMBA were discovered in both companies' products.

US warns of ‘growing problem’ of counterfeit medicine

26-Apr-2019 By Ben Hargreaves

A US trade report identified that counterfeit drugs are becoming a greater issue through illegitimate online sales, particularly in countries such as China and India.

GSK ramps up Shingrix production with $100m investment

25-Apr-2019 By Ben Hargreaves

GSK announces that it will spend $100m to expand production capacity for components of Shingrix, amid a US market where demand outstrips supply of its shingles vaccine.

Hovione Technology acquires rights to pulmonary inhaler

23-Apr-2019 By Ben Hargreaves

Hovione Technology reaches an agreement to acquire the global rights to a reusable, cost-efficient, dry-powder inhaler.

Explosion at Chinese pharmaceutical plant leaves 10 dead

22-Apr-2019 By Ben Hargreaves

Dozens hurt and 10 people dead after an accident during renovation work in Shandong province, China.

Vetter’s Chicago-based manufacturing facility expansion to meet the region’s CDMO needs

18-Apr-2019 By Maggie Lynch

Completion of early-stage development site expansion at the Illinois Science and Technology Park supplies Chicago-based drug companies with refrigeration services for complex APIs.

Gilead doubles down on NASH with two deals in one week

16-Apr-2019 By Ben Hargreaves

Gilead arranges partnerships with insitro and Novo Nordisk to develop new options for patients with NASH.

Enesi and Oxford University look to create first effective plague vaccine

16-Apr-2019 By Vassia Barba

Enesi Pharma and OVG sign a collaborative agreement, hoping to combine a promising ingredient and an innovative delivery method to produce a plague vaccine.

Global API market set to grow to $268bn by 2025

12-Apr-2019 By Ben Hargreaves

The global API market will achieve a CAGR of 6.8% running up to 2026, taking the total value to $268bn, a report suggests.

LEO partners to reduce multi-hour dermatology treatments to seconds

11-Apr-2019 By Vassia Barba

LEO and Elektrofi begin development of injectable dermatological drugs to replace infusions, reducing the amount of time required for treatment.

GSK gets first approval for two-drug HIV treatment

09-Apr-2019 By Ben Hargreaves

GSK’s Dovato is approved by the US FDA for the treatment of individuals with HIV with no previous antiretroviral therapy, in a first for a two-drug, fixed-dose, complete regimen.