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GMP Certificate 2023

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DATA COMPILATION #PharmaFlow

CDMO Activity Tracker: Novo’s parent buys Catalent for US$ 16.5 bn; Fujifilm, Merck KGaA, Axplora expand capabilities

During the first half (H1) of 2024, the global contract development and manufacturing organization (CDMO) landscape was driven by the escalating demand for complex drug development and manufacturing.With the industry grappling with constantly evolving therapeutic modalities, CDMOs are racing to invest in cutting-edge technologies and infrastructure to meet the growing needs of pharmaceutical and biotech companies.Some of the key players in the CDMO space are Catalent, EUROAPI, Lonza, Axplora, Thermo Fisher, SEQENS, Samsung Biologics, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Famar, LGM Pharma, Veranova, and Evonik. View CDMO Activity Tracker for H1 2024 (Free Excel Available)Novo’s parent buys Catalent for US$ 16.5 bn; Bora, Lonza, Siegfried expand US footprintDuring H1 2024, several European and Asian drugmakers expanded their footprints in the US. In February, Novo Nordisk’s parent company, the Novo Nordisk Foundation, announced the acquisition of Catalent through its investment arm Novo Holdings for US$ 16.5 billion. Novo Holdings plans to sell three of Catalent’s “fill-finish” sites to Novo Nordisk for US$ 11 billion. The deal is expected to allow the Danish drugmaker “to serve significantly more people living with diabetes and obesity,” a company statement said.Taiwan-headquartered Bora Pharmaceuticals forged ahead with its expansion plans in the US market by acquiring Minnesota-based generics manufacturer Upsher-Smith Laboratories. Emergent BioSolutions said it is selling its Maryland facility to an affiliate of Bora. This site in Camden is part of its CDMO, Emergent Bioservices, and offers clinical and commercial non-viral aseptic fill/finish services on four fill lines, including lyophilization, formulation development, and support services.Swiss drugmaker Lonza has agreed to acquire Genentech’s manufacturing facility in California, US, from Roche for US$ 1.2 billion in cash. The site, located in the city of Vacaville, is one of the largest biologics manufacturing facilities in the world by volume.Lonza also launched an artificial intelligence-driven route design technology for choosing the optimal synthetic pathway to manufacture novel APIs.Switzerland’s Siegfried is acquiring a Wisconsin (US)-based CDMO that specializes in early-phase development and manufacturing services from Curia Global to strengthen its capabilities in North America. Siegfried will further develop the site into its North American Siegfried Acceleration Hub for early-phase CDMO services. View CDMO Activity Tracker for H1 2024 (Free Excel Available) Merck Millipore, SK Bioscience lead CGT boom; Fujifilm, Axplora, expand CDMO capabilitiesThe burgeoning field of cell and gene therapies (CGTs) is driving significant investments in CDMOs. CGTs saw considerable deal-making too. Merck KGaA agreed to buy Wisconsin-based Mirus Bio for US$ 600 million. Mirus Bio is a specialist in the development and commercialization of transfection reagents that are used to help introduce genetic material into cells. These reagents play a key role in the production of viral vectors for CGTs.Similarly, South Korea’s SK Bioscience acquired a 60 percent stake in IDT Biologika GmbH for KRW 339 billion (US$ 244 million). IDT Biologika is a 104-year-old German company that ranks among the top 10 vaccine producers in the world.CDMOs are also expanding their capabilities in order to lead innovation for their pharmaceutical partners. Fujifilm Diosynth Biotechnologies is investing US$ 1.2 billion in its large-scale cell culture CDMO business to further expand its end-to-end bio-manufacturing facility in North Carolina, bringing the total investment in the facility to over US$ 3.2 billion. Similarly, Merck KGaA owned MilliporeSigma made its biggest investment in the Asia-Pacific region in March when it invested € 300 million (US$ 327 million) in a new bioprocessing production center in Daejeon, South Korea.German CDMO giant Axplora is investing € 8 million (US$ 8.73 million) to expand capacity for antibody drug conjugate (ADC) payload manufacturing at its Le Mans site in France. Catalent completed upgrades to its capsule filling capabilities of dry powders for inhalation to handle potent drugs at its Boston facility. This now positions Catalent as the CDMO with the largest GMP capacity for capsule spray-dried and carrier-based inhaled powders.LGM Pharma increased its Analytical Testing Services (ATS) by 50 percent with a US$ 2 million investment and introduced new suppository manufacturing capabilities to its CDMO portfolio. Minakem has invested in a new production unit in Montreal, Canada, for steroid APIs. View CDMO Activity Tracker for H1 2024 (Free Excel Available) EUROAPI kicks off four-year sweeping plan; LegoChem partners Samsung Biologics for ADC programSanofi’s spinoff EUROAPI marked 2024 as a “transition year”, setting in motion its Focus-27 plan for profitable growth in the future. The sweeping four-year plan includes a streamlined value-added portfolio focused on highly differentiated and profitable APIs, and a CDMO focused on late-stage and high-value complex small molecules and tides supported by unique technological platforms. The leading French small molecules player signed a five-year collaboration with Ireland’s Priothera wherein EUROAPI will develop and industrialize the manufacturing process of an innovative, complex molecule for blood cancers – mocravimod. The project will be carried out at EUROAPI’s site in Budapest, which is its center of excellence for complex chemistry.South Korea’s CDMO powerhouse Samsung Biologics has partnered LegoChem Biosciences and will provide antibody development and drug substance manufacturing services as a part of LegoChem’s ADC program designed to treat solid tumors. LegoChem aims to submit an investigational new drug application to the US Food and Drug Administration (FDA) in the first half of 2025. Aurigene and Vipergen have joined forces to offer DNA-encoded library (DEL) screening for drug discovery. By combining Aurigene’s drug discovery capabilities with Vipergen’s DEL screening technologies, they seek to create a powerful tool that can quickly test over a billion small-molecule compounds against different disease targets. Dr. Reddy’s Laboratories’ company Aurigene also inaugurated its biologics facility spread across 70,000 square feet.Chinese biotech startup Pleryon is collaborating with France’s SEQENS, a leader in specialty ingredients, to develop and manufacture the former’s lead candidate, an innovative polymer to treat osteoarthritis. Famar is collaborating with Lavipharm and will serve as the contract manufacturer for the latter’s recently added analgesic pharmaceutical products — Lonarid N and Lonalgal. View CDMO Activity Tracker for H1 2024 (Free Excel Available) Our view Key trends observed in H1 2024 include a surge in investments for fill-finish facilities, a growing emphasis on cell and gene therapies, and advancements in ADC manufacturing. With the proliferation of these new classes of drugs, the CDMO space has been rapidly changing in recent years. In the future, the integration of digital technologies, such as AI and automation, will be a key differentiator for CDMOs looking to optimize their operations and accelerate drug development timelines.

Impressions: 2737

Ophthalmic Dealmakers: Novartis, AbbVie forge deals to develop ocular gene therapies

During the Covid-19 pandemic and the concomitant lockdowns, people may have found it difficult to visit eye clinics or hospitals, but globally, ophthalmology has been witnessing a healthy growth. Several factors are contributing to this growth, such as increasing prevalence of eye diseases due to factors like diabetes, rising geriatric population the world over, and disorders linked to increased screen time. As a result, we are seeing several Big Pharma increase their focus on ophthalmology. According to various market studies, the market for ophthalmic drugs is growing at 5.6 to 6.52 percent per annum. The size of the global ophthalmology market was estimated to be US$ 55.28 billion in 2021, and is projected to grow at a compounded annual rate of 6.52 percent to reach US$ 81.05 billion by 2027. In our first ophthalmic review, we look at the major players in the market, significant deals in the recent past, various ocular diseases and conditions, generic and first-time approvals, and future projections. Access the Ophthalmology Newsmakers Dashboard Increasing focus on geographic atrophy The global ophthalmology market is dominated by players such as Novartis, Bausch & Lomb, F. Hoffmann La-Roche, Regeneron Pharmaceuticals, Allergan, Alcon and Japanese drugmaker Santen Pharmaceutical, among others. The top medical conditions in ophthalmology are age-related macular degeneration (AMD) and macular edema, dry eye syndrome, glaucoma, cataract, retinitis pigmentosa and diabetic retinopathy, presbyopia, and uveitis. Topical, local ocular (i.e., subconjunctival, intravitreal, retrobulbar, and intracameral), and systemic delivery are the most frequently used approaches to deliver ocular drugs, though a number of modern ocular delivery systems are gaining popularity. Geographic atrophy (GA), an advanced form of AMD, is a condition that affects the retina, a part of the eye that sends information to the brain to enable sight. GA is a leading cause of blindness, affecting approximately 5 million patients worldwide, with no approved treatment. A significant amount of deals in ophthalmology were triggered by GA. Take the case of Novartis. In November last year, the Swiss drugmaker decided to offload its stake in Roche for US$ 20.7 billion. And the very next month, it acquired UK-based Gyroscope Therapeutics for US$ 1.5 billion. The acquisition will add an investigational, one-time gene therapy for the treatment of GA to Novartis’ portfolio. The therapy, GT005, is currently in phase 2 clinical trials. Gyroscope also has several other retinal diseases-related assets in its pipeline. In October 2020, Novartis had acquired Vedere Bio, which gave the drug behemoth access to two pre-clinical optogenetic AAV gene therapy programs and novel delivery technology for treating inherited retinal dystrophies and GA, among other drug programs. Similarly, in May 2020, Boehringer Ingelheim had collaborated with CDR-Life to develop antibody fragment-based therapeutics for GA. Other companies developing GA products are Apellis Pharmaceuticals-Sobi and Annexon Biosciences. Access the Ophthalmology Newsmakers Dashboard Recent deals in ophthalmology Last year saw AbbVie and Regenxbio collaborate on developing and commercializing RGX-314, a potential one-time gene therapy for the treatment of wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR), and other chronic retinal diseases. RGX-314 is currently being evaluated in patients with wet AMD in a pivotal trial utilizing sub-retinal delivery, and in patients with wet AMD and DR in two separate phase 2 clinical trials utilizing in-office suprachoroidal delivery. Similarly, in December, Lineage Cell Therapeutics entered into an exclusive worldwide collaboration and license agreement with Roche and Genentech for the development and commercialization of a retinal pigment epithelium (RPE) cell therapy for the treatment of ocular disorders, including advanced dry age-related macular degeneration (dry AMD) with GA. The same month, Aerie Pharmaceuticals had announced an exclusive development and commercialization agreement with Santen for Rhopressa/Rhokiinsa (netarsudil ophthalmic solution) and Rocklatan/Roclanda (netarsudil and latanoprost ophthalmic solution). The expanded collaboration includes Europe, Commonwealth of Independent States (CIS) countries, China, India, parts of Latin America and the Oceania countries. In October 2020, Swedish Orphan Biovitrum AB or Sobi and Apellis Pharmaceuticals had announced a strategic collaboration to accelerate the advancement of systemic pegcetacoplan, a targeted C3 therapy for the treatment of multiple rare diseases with high unmet need that impact over 275,000 patients globally. Bausch Health had spun off its eye-care business in August 2020 to unlock value in its iconic brand and its integrated portfolio of eye health products. The spin-off has established two separate companies (a) a pure play eye-health company; and (b) a diversified pharmaceutical company with leading positions in gastroenterology, aesthetics/dermatology, neurology, and international pharmaceuticals. In January this year, Bausch & Lomb announced that it plans to raise US$ 100 million through an initial public offering. Last year, Akorn sold off its consumer health business to an affiliate of Prestige Consumer Healthcare for US$ 230 million. The sell-off included popular over-the-counter ophthalmology drug — TheraTears — besides several other products. Access the Ophthalmology Newsmakers Dashboard FDA approves first generic for Restasis Generic drugs offer cheaper alternatives to patients across the world. This year, ophthalmology saw the biggest generic approval when Mylan Pharmaceuticals, now Viatris, became the first company to bag the US Food and Drug Administration’s nod for Restasis (cyclosporine ophthalmic emulsion). Allergan had transferred patents for the ophthalmic form Restasis to the St. Regis tribe of the Mohawk people in the US to avoid competition. Following the deal, the American drugmaker had received heavy criticism. On February 23, 2018, the US Patent and Trademark Office deemed the Restasis patents invalid and rejected the tribe’s ability to use sovereign immunity to protect the Restasis patents. The other important generic approval was both the FDA and European Medicines Agency’s (EMA) approval of Samsung Bioepis and Biogen’s Byooviz, a biosimilar candidate referencing Lucentis (ranibizumab). While the FDA approval came in September, the EMA nod was given a few months earlier. Byooviz has been approved for the treatment of neovascular wet AMD, visual impairment due to diabetic macular edema (DME), proliferative diabetic retinopathy (PDR), visual impairment due to macular edema, secondary to retinal vein occlusion (branch RVO or central RVO), and visual impairment due to choroidal neovascularization (CNV) in the European Union (EU). Among first-time approvals, FDA approved Allergan’s Vuity (pilocarpine HCl ophthalmic solution) in October last year. This is the first and only eye drop approved by the FDA to treat presbyopia, an age-related blurry near vision. Presbyopia is a common and progressive eye condition that affects 128 million Americans, or nearly half of the adult population in the US. The other important drug that bagged FDA approval this year was Roche’s Vabysmo. The drug targets and inhibits two disease pathways that drive neovascular or wet AMD and DME. Vabysmo is the only injectable eye medicine approved simultaneously in the US for wet AMD and DME, with flexible dosing regimens based on patient needs. Access the Ophthalmology Newsmakers Dashboard Our view Over the last few years, gene therapy, stem cell therapy, and target discovery through genomic research have shown considerable promise as potential strategies to achieve tissue repair or regeneration in the treatment of ocular diseases, such as AMD. At present, a number of gene therapies are undergoing clinical investigations for AMD. Moreover, several modern ocular delivery systems have made significant advances and have proven to be safe and effective. Similarly, artificial retinas, 3D bioprinting and electronic support devices for patients with visual impairments are some promising technologies that will see more growth in the future. According to the World Health Organization (WHO), the aging population is expected to burden all areas of healthcare. Interestingly, ophthalmologists provide approximately 90 percent of their procedure-based services to seniors. Therefore, the market is bound to see healthy growth rates, with newer therapies and ocular delivery systems. Access the Ophthalmology Newsmakers Dashboard

Impressions: 4742

NEWS #PharmaBuzz

Success Factors for Pre-Filled Syringe CMO Selection

15 Jul 2024

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AbbVie Preps Global Parenteral Sites For Annex 1 Compliance Requirements

24 Jun 2024

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Translating Environmental, Social and Governance (ESG) Benefits to our Partners

10 May 2024

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AbbVie Contract Manufacturing – 12-Time CMO Leadership Award Winner

20 Mar 2024

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AbbVie Contract Manufacturing Recognized by Life Science Leader for the 11th Year

11 Mar 2024

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Four Myths About Embedded CMOs, Busted

18 Jan 2024

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ALL APIs

01

Cyclosporine

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

AusBiotech 2024

Not Confirmed

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02

Erythromycin

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

AusBiotech 2024

Not Confirmed

USDMF

CEP/COS

JDMF EU-WC NDC KDMF VMF Others AUDIT

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03

Erythromycin

U.S.A

Ritonavir

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

AusBiotech 2024

Not Confirmed

USDMF CEP/COS

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FDA

01 FDA Audited

USA

District Decision : No Action Indicated

Inspection End Date : 2020-01-10

City : Grayslake

State : IL

Country/Area : US

Zip : 60030-3910

District : CHI

Center : CDER

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2020-01-10

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02 FDA Audited

USA

District Decision : Voluntary Action Indicated

Inspection End Date : 2019-03-25

City : Barceloneta

State : PR

Country/Area : US

Zip : 00617

District : SJN

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2019-03-25

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03 FDA Audited

USA

District Decision : Voluntary Action Indicated

Inspection End Date : 2018-06-01

City : Barceloneta

State : PR

Country/Area : US

Zip : 00617

District : SJN

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2018-06-01

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04 FDA Audited

USA

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-04-28

City : Barceloneta

State : PR

Country/Area : US

Zip : 00617

District : SJN

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-04-28

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05 FDA Audited

USA

District Decision : Voluntary Action Indicated

Inspection End Date : 2016-03-24

City : Barceloneta

State : PR

Country/Area : US

Zip : 00617

District : SJN

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2016-03-24

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06 FDA Audited

USA

District Decision : Voluntary Action Indicated

Inspection End Date : 2014-07-16

City : Barceloneta

State : PR

Country/Area : US

Zip : 00617

District : SJN

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2014-07-16

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07 FDA Audited

USA

District Decision : Voluntary Action Indicated

Inspection End Date : 2012-07-12

City : Barceloneta

State : PR

Country/Area : US

Zip : 00617

District : SJN

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2012-07-12

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08 FDA Audited

USA

District Decision : Voluntary Action Indicated

Inspection End Date : 2011-04-29

City : Barceloneta

State : PR

Country/Area : US

Zip : 00617

District : SJN

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2011-04-29

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09 FDA Audited

USA

District Decision : No Action Indicated

Inspection End Date : 2009-03-04

City : Barceloneta

State : PR

Country/Area : US

Zip : 00617

District : SJN

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2009-03-04

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10 FDA Audited

USA

District Decision : No Action Indicated

Inspection End Date : 2019-11-18

City : Worcester

State : MA

Country/Area : US

Zip : 01605-4312

District : NWE

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2019-11-18

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EDQM

01

GMP Certified

Type : GMP Certificates

Number : IT/195/H/20...

EudraGMDP Key : 153940

Country : Italy

Issue Date : 2022-11-11

Post Code : 04011

NCA Ref : 000000100069

City : Campoverde Di Aprilia

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02

GMP Certified

Type : GMP Certificates

Number : IT-API/27/H...

EudraGMDP Key : 159610

Country : Italy

Issue Date : 2022-02-10

Post Code : 04011

NCA Ref : 000000100069

City : Campoverde Di Aprilia

Product
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03

GMP Certified

Type : GMP Certificates

Number : IT-API/90/H...

EudraGMDP Key : 90122

Country : Italy

Issue Date : 2020-05-27

Post Code : 04011

NCA Ref : 100069

City : APRILIA

Product
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04

GMP Certified

Type : GMP Certificates

Number : NBF/29/2021...

EudraGMDP Key : 131295

Country : Italy

Issue Date : 2021-06-09

Post Code : 04011

NCA Ref : 210

City : APRILIA (LT)

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05

GMP Certified

Type : GMP Certificates

Number : IT/94/H/202...

EudraGMDP Key : 151772

Country : Italy

Issue Date : 2022-05-16

Post Code : 04011

NCA Ref : 000000100069

City : Campoverde Di Aprilia

Product
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06

GMP Certified

Type : GMP Certificates

Number : IT-API/49/H...

EudraGMDP Key : 47272

Country : Italy

Issue Date : 2018-04-05

Post Code : 04011

NCA Ref : 100069

City : APRILIA

Product
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07

GMP Certified

Type : GMP Certificates

Number : IT-API/116/...

EudraGMDP Key : 48684

Country : Italy

Issue Date : 2018-06-25

Post Code : 04011

NCA Ref : 100069

City : APRILIA

Product
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08

GMP Certified

Type : GMP Certificates

Number : UK GMP 4219...

EudraGMDP Key : 33433

Country : U.S.A

Issue Date : 2016-01-27

Post Code : 60064-4000

NCA Ref : 13845244-ABB...

City : NORTH CHICAGO

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09

GMP Certified

Type : GMP Certificates

Number : UK GMP 4219...

EudraGMDP Key : 33989

Country : U.S.A

Issue Date : 2016-03-04

Post Code : 60064-4000

NCA Ref : 13878506-ABB...

City : NORTH CHICAGO

Product
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10

GMP Certified

Type : GMP Certificates

Number : UK GMP 4219...

EudraGMDP Key : 24458

Country : U.S.A

Issue Date : 2014-08-05

Post Code : 60064-4000

NCA Ref : 16075- ABBVI...

City : NORTH CHICAGO

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GDUFA

01 GDUFA fees paid

USA

AusBiotech 2024

Not Confirmed

Paid in : 2024

API Manufacturer :

FDF Manufacturer : FDF MANUFACTURE

Facility Name : AbbVie INC

Business Address : 1 N Waukegan Road North Chic...

FEI Number : 3009751352

Country : U.S.A

Paid in : 2024

Product
Web Link

02 GDUFA fees paid

USA

AusBiotech 2024

Not Confirmed

Paid in : 2024

API Manufacturer : API MANUFACTURE

FDF Manufacturer :

Facility Name : AbbVie INC

Business Address : 1401 Sheridan Road North Chi...

FEI Number : 1411365

Country : U.S.A

Paid in : 2024

Product
Web Link

03 GDUFA fees paid

USA

AusBiotech 2024

Not Confirmed

Paid in : 2024

Allergan Aesthetics

API Manufacturer :

FDF Manufacturer : FDF MANUFACTURE

Facility Name : Allergan Pharmaceuticals Irela...

Business Address : Castlebar Road Westport Coun...

FEI Number : 3002806285

Country : U.S.A

Paid in : 2024

Product
Web Link

04 GDUFA fees paid

USA

AusBiotech 2024

Not Confirmed

Paid in : 2024

Allergan Aesthetics

API Manufacturer :

FDF Manufacturer : FDF MANUFACTURE

Facility Name : Allergan Sales LLC

Business Address : 8301 Mars Drive Waco TX 7671...

FEI Number : 1643525

Country : U.S.A

Paid in : 2024

Product
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