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    Company profile for Patheon

    AMI Lifesciences is Driven by Chemistry. Powered by People.

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    Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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    Bhavna Laboratories is an API & Intermediate manufacturer focusing on the muscle relaxant & ophthalmic segments.

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    Zach System is committed to providing Highly Customized Solutions for all your Development Programs.

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    Quotient Sciences- Molecule to Cure. Fast.

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    pharmacompass-2-m-2025-08-25

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    About

    With a commitment to quality, scientific excellence and exceptional customer experiences, Patheon is a leading global provider of contract drug development and manufacturing services. Our integrated network consists of eight development centres of excellence and thirteen manufacturing facilities across North America and Europe.Patheon provides pharmaceutical and biotechnology companies with direct access to the expertise, qual...
    With a commitment to quality, scientific excellence and exceptional customer experiences, Patheon is a leading global provider of contract drug development and manufacturing services. Our integrated network consists of eight development centres of excellence and thirteen manufacturing facilities across North America and Europe.Patheon provides pharmaceutical and biotechnology companies with direct access to the expertise, quality and full range of solid and sterile dosage forms to bring drug candidates from preclinical stages through production, and launch products anywhere in the world.

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    PatheonUnited_States_of_America Flag
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    4815 Emperor Blvd., Suite 300
 Durham, NC 27703-8470
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    +1 919 226 3200
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    "50 Years of Innovation: Mikart

    mic"50 Years of Innovation: Mikart's legacy and what's next in CDMO excellence"

    This week, SpeakPharma interviews Michael Kallelis, CEO of Mikart, a leading contract development and manufacturing organization (CDMO) celebrating its 50th anniversary in the pharmaceutical industry. Based in the United States, Mikart has built a reputation for technical expertise, flexible business terms, and specialized capabilities in pharmaceutical development services. In this exclusive interview, Kallelis discusses how Mikart maintains its competitive edge through its Pharmaceutical Development Services team, quality control framework, and commitment to customized business solutions. Kallelis also explores the company's focus on liquid suspensions manufacturing, driven by growing demand from aging populations and pediatric patients, and explains how Mikart balances traditional family business values with modern innovation. HIGHLIGHTS// celebrating its 50th anniversary/ reputation for technical expertise/ how Mikart maintains its competitive edge Mikart is celebrating 50 years in business this year — what are some of the major milestones that have shaped the company's journey?  Over our 50-year history, we've celebrated many memorable milestones, but one of the most significant in recent years has been achieving our growth objectives. This success was driven by the strategic expansion of our Pharmaceutical Development Services team, the completion of full aggregate serialization in our packaging department, modernization of our IT systems, enhanced productivity, and our ability to attract both new and returning customers. HIGHLIGHTS// expansion of our Pharmaceutical Development Services team/ completion of full aggregate serialization/ attract both new and returning customers How has Mikart maintained its competitive edge in a constantly evolving pharmaceutical landscape? Our customers consistently tell us that what sets us apart is our technical expertise, high service level, and flexible, customized business terms. At the core of our competitiveness is our focus on Pharmaceutical Development Services (PDS). Mikart's PDS opinion leaders are actively engaged in business development and form early, collaborative relationships with our customers' technical teams. From the outset, our prospects and clients work directly with Mikart's experienced formulation chemists, analytical method developers, and process-oriented engineers to design robust, reproducible, and efficient processes. This hands-on development approach is supported by a comprehensive quality control testing framework — covering raw material testing, in-process checks, on-site microbiological testing, and in-house stability studies. Oversight is provided by our robust Quality Management System, managed by a dedicated Quality Assurance and Regulatory Affairs team. The result is disciplined problem-solving, timely FDA submissions, and a "right-first-time" philosophy that accelerates time-to-market. We operate with a strong sense of urgency and consistently deliver a high level of customer satisfaction. What truly differentiates Mikart is our commitment to customized business terms that eliminate common roadblocks seen with other CDMOs. Our secret sauce is our exceptional service and flexibility in helping our customers bring innovative medicines to patients. HIGHLIGHTS// technical expertise, high service level/ flexible, customized business terms/ comprehensive quality control testing framework/ dedicated Quality Assurance and Regulatory Affairs team/ timely FDA submissions/ accelerates time-to-market What capabilities or services does Mikart offer today that didn't exist 10 or 20 years ago? Mikart was an early leader in serialization, implementing full capabilities well ahead of the industry timeline. This proactive approach has kept our packaging team in high demand. We also upgraded our tablet compression equipment to enhance both speed and reliability. To support growing development needs, we invested in new lab-scale development equipment, unit dose cup filling, sachet packaging, low-humidity suites, and a brand-new suite dedicated to closed-system manufacturing of liquids and suspensions. Most recently, we launched a multi-million dollar expansion of our packaging lines to support higher-speed tablet filling, powder-in-bottle formats, and new liquid fill capabilities. HIGHLIGHTS// early leader in serialization/ upgraded our tablet compression equipment/ multi-million dollar expansion of our packaging lines Why are liquid suspensions becoming such a key focus, and how is Mikart positioned? Formulating suspensions is a complex process that requires specialized expertise and equipment. According to our customers, few mid-market CDMOs do it well — and Mikart is one of them. There is growing industry demand for high-quality suspension manufacturing, driven by the needs of the aging baby boomer population and pediatric patients. For both groups, swallowing tablets or capsules can be difficult, making oral liquid suspensions a more practical alternative. In addition to being easier to administer, suspensions offer pharmacological advantages and can improve dosing compliance. Enhanced flavoring techniques further improve the patient experience — especially for children and infants — by making medicines more palatable. HIGHLIGHTS// growing industry demand for high-quality suspension manufacturing/ suspensions offer pharmacological advantages/ improve dosing compliance How does Mikart balance tradition with innovation to meet modern customer demands?  At Mikart, we work hard to preserve the values of a traditional family business, even as we continue to modernize. Our goal is to make every customer feel like they are our top priority. Each customer is supported by a dedicated project manager who serves as their primary point of contact, along with direct access to key team members across departments. This structure ensures our customers are never isolated from our subject matter experts and can get timely, accurate answers to their questions. We're also mindful of the "technology trap" — the tendency to pursue every new innovation at the expense of focus and efficiency. Instead, we rely on market data and customer trends to guide our investments, enabling us to concentrate our resources and capital on technologies that meet real market needs. HIGHLIGHTS// customer is supported by a dedicated project manager/ customers are never isolated from our subject matter experts/ we rely on market data and customer trends to guide our investments/ meet real market needs Looking ahead, what's in store for Mikart in the next 5-10 years? Mikart's strategic plan is now in full motion, and with the momentum we've built, 50 percent growth is within reach. This projection is backed by a strong pipeline of annual FDA filings, a growing customer base, and a robust portfolio of active Pharmaceutical Development Services projects. As we grow, we remain committed to delivering exceptional service and continuously evolving to meet the changing needs of our customers. With renewed political emphasis on domestic manufacturing for the US market, we are ideally positioned to support the rapid, cost-effective development and production of high-quality medicines here at home. As we approach our 50th anniversary in the CDMO industry, we celebrate our legacy and look forward with optimism to the opportunities ahead in the next 5 to 10 years. HIGHLIGHTS// 50 percent growth is within reach/ strong pipeline of annual FDA filings 

    Impressions: 2623

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    https://www.pharmacompass.com/speak-pharma/50-years-of-innovation-mikart-s-legacy-and-what-s-next-in-cdmo-excellence

    PharmaCompass
    17 Jul 2025
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    VLOG #PharmaReel

    [Sponsored by another company]

    ReelPharmaVersatile Source for Prostaglandin APIsVersatile Source for Prostaglandin APIs

    Versatile Source for Prostaglandin APIs
    Versatile Source for Prostaglandin APIs

    reelVersatile Source for Prostaglandin APIs

    This PharmaReel spotlights Cayman Pharma’s expertise in Prostaglandin APIs, backed by Czech NCA (SUKL, USKVBL) and USFDA approvals. With patented technology, process excellence, and quality focus, Cayman is a trusted partner for reliable CDMO services.

    Impressions: 7765

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    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    FDA approvals drop 24% in H1 2025; GSK’s UTI med, Vertex’s non-opioid painkiller lead pack of first-in-class meds

    FDA approvals drop 24% in H1 2025; GSK’s UTI med, Vertex’s non-opioid painkiller lead pack of first-in-class meds

    It has been a turbulent year for the US Food and Drug Administration (FDA), marked by reductions in both staff and budget, shake-ups at the top and a reduction in inspections. This upheaval has clearly impacted the functioning of the agency, with reports of missed deadlines and reduced responsiveness. This disruption resulted in a slowdown in new drug approvals in the first half of 2025 (H1 2025), as opposed to the same period last year. Incidentally, drug approvals in H1 2024 were also down by 19 percent compared to H1 2023. FDA’s Center for Drug Evaluation and Research (CDER) approved 16 novel drugs in H1 2025, down from 21 in H1 2024, a decline of nearly 24 percent. Of these, nine were small molecules and seven were biologics. The period saw eight first-in-class therapies get CDER’s approval, as opposed to 17 in H1 2024. FDA’s Center for Biologics Evaluation and Research (CBER) approved seven biologics in H1 2025, compared to eight in the same period last year. In comparison, both Health Canada and the European Medicines Agency (EMA) reported a strong rebound in approvals and authorizations, respectively. Health Canada approved 20 drugs in H1 2025, as opposed to 10 in H1 2024. Similarly, EMA authorized 19 new therapies in H1 2025, compared to 15 in H1 2024. Notably, EMA’s pending decisions increased to 25 in H1 2025, from 14 in the same period last year, while conditional authorizations remained static at five. This underscores EMA’s active regulatory pipeline, suggesting that more drugs could be approved in Europe soon.   View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available) Vertex’s non-opioid painkiller, GSK’s antibiotic for UTI, Merck’s RSV antibody bag FDA nods Oncology remained the single largest category in H1 2025 with seven new drugs being approved by the FDA, followed by four rare diseases and disorders and as many infections and infective diseases.  The eight drugs that were designated first-in-class in H1 2025 are: Journavx (Suzetrigine), Imaavy (nipocalimab), Emrelis (telisotuzumab vedotin), Blujepa (gepotidacin mesylate), Qfitlia (fitusiran), Avmapki Fakzynja Co-Pack (avutometinib potassium/defactinib hydrochloride), Tryptyr (acoltremon), and Andembry (garadacimab). In January, a new class of non-opioid pain therapy made a debut — FDA approved Vertex Pharmaceuticals’ Journavx (suzetrigine). This first-in-class oral analgesic could bring in US$ 2.9 billion in sales for Vertex by 2030. The half year also saw a new oral antibiotic — GSK’s Blujepa (gepotidacin) — for treating uncomplicated urinary tract infections (uUTIs) bag FDA approval. This is the first new antibiotic for uUTIs in nearly three decades. It treats infections caused by resistant pathogens such as E. coli and K. pneumoniae. In June, Merck’s Enflonsia (clesrovimab), a long-acting monoclonal antibody, won FDA approval to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants entering their first RSV season. A single 105 mg dose provides protection for about five months, the length of a typical RSV season. Enflonsia could bring in US$844 million in annual sales by 2030.   View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available)  FDA approves four meds for rare diseases, including SpringWorks’ Gomekli, Novartis’ Vanrafia In H1 2024, rare genetic diseases had witnessed some significant approvals. The trend continued in H1 2025. In February, Gomekli (mirdametinib), developed by SpringWorks Therapeutics, became the first approved therapy for neurofibromatosis type 1 (a genetic disorder that causes tumors to grow on nerve tissues) in adult and pediatric patients who have symptomatic plexiform neurofibromas (benign, complex nerve tumors) not amenable to complete resection. Analysts expect peak sales of around US$ 0.8 billion by 2030. Post this approval, SpringWorks got acquired by Merck KGaA for approximately US$ 3.9 billion. The same month, Ono Pharma-owned Deciphera’s Romvimza (vimseltinib) became the first oral therapy approved for another rare disease known as symptomatic tenosynovial giant cell tumor. This is a benign but aggressive growth that can be painful. This new drug offers patients an option beyond surgery. In March, Sanofi’s Qfitlia (fitusiran) was approved for routine prophylaxis in hemophilia A or B, with or without inhibitors. And in April, Novartis’ Vanrafia (atrasentan) was granted accelerated approval for IgA nephropathy (a chronic autoimmune kidney disease), which is at the risk of rapid progression. Vanrafia could bring in sales of over US$ 735 million by 2030. Johnson & Johnson secured approval for Imaavy (nipocalimab-aahu) for generalized myasthenia gravis (a chronic autoimmune disease that causes muscle weakness) in adults and adolescents. Imaavy’s sales could cross US$1.17 billion by 2030. Rare diseases continue to attract regulatory attention, with the trend carrying into the current quarter. July witnessed two noteworthy rare-disease approvals — Ekterly (garadacimab), CSL’s once-monthly prophylactic treatment for hereditary angioedema (a genetic disorder that causes recurrent episodes of swellings), and Sephience (pegvaliase-abcx), BioMarin’s new therapy for phenylketonuria (a rare metabolic disorder).   View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available)  FDA greenlights new oncology therapies, including Astra’s Datroway, AbbVie’s Emrelis The field of oncology saw some notable new drug approvals. In January, Datroway (datopotamab deruxtecan), an antibody-drug conjugate (ADC) developed by AstraZeneca and Daiichi Sankyo, was granted approval for adults with unresectable or metastatic, hormone receptor-positive, HER2-negative breast cancer. Later, in June, the FDA granted accelerated approval  to AstraZeneca;s Datroway for adults with locally advanced or metastatic, EGFR-mutated non-small cell lung cancer. The drug’s peak annual sales are projected at about US$ 4.2 billion by 2030. In May, Emrelis (telisotuzumab vedotin-tllv), AbbVie’s ADC was granted FDA’s accelerated approval. Emrelis treats locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) characterized by significantly increased levels of the c-Met protein in cancer cells. FDA also approved a companion diagnostic test — Roche's Ventana — in May to determine the c-Met protein biomarker status in order to identify patients eligible for Emrelis.  The same month, FDA also granted accelerated approval to Verastem’s Avmapki Fakzynja Co-pack, a dual oral therapy for adults with KRAS‑mutated recurrent low‑grade serous ovarian cancer (LGSOC). This novel regimen combines two inhibitors — avutometinib and defactinib — to disrupt critical signaling pathways that fuel tumor growth. In ophthalmology, Alcon re-entered the prescription pharmaceutical market with Tryptry (acoltremon), a first-in-class TRPM8 agonist for dry eye disease, which stimulates corneal nerves to increase tear production.   View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available)  Our view The changes in the FDA are clearly having a far-reaching impact on the global pharmaceutical industry. There have been reports of drugmakers losing confidence in the FDA, which has been a gold standard for drug regulation. Some American biotechs are shifting early trials outside of the US. With EMA and Health Canada authorizing/approving a larger number of drugs in H1 2025, we do see some changes underway that may eventually reshape drug development.  
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    Impressions: 2053

    https://www.pharmacompass.com/radio-compass-blog/fda-approvals-drop-24-in-h1-2025-gsk-s-uti-med-vertex-s-non-opioid-painkiller-lead-pack-of-first-in-class-meds

    #PharmaFlow by PHARMACOMPASS
    28 Aug 2025
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    NEWS #PharmaBuzz

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    Nick Buschur takes over as CEO at blow-fill-seal CDMO Woodstock
    Nick Buschur takes over as CEO at blow-fill-seal CDMO Woodstock

    07 Jan 2025

    // FIERCE PHARMA

    https://www.fiercepharma.com/manufacturing/new-woodstock-ceo-buschur-plots-growth-strategy-blow-fill-seal-cdmo

    FIERCE PHARMA
    07 Jan 2025
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    FDA Issues Form 483 to Patheon Italia S.p.A
    FDA Issues Form 483 to Patheon Italia S.p.A

    27 Nov 2024

    // FDA

    https://www.fda.gov/media/183884/download

    FDA
    27 Nov 2024
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    Patheon`s Generic Ibuprofen Receives Approval in the U.S.
    Patheon`s Generic Ibuprofen Receives Approval in the U.S.

    13 Feb 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217236

    FDA
    13 Feb 2024
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    Patheon's Generic Naproxen Sodium Receives Approval in the U.S.
    Patheon's Generic Naproxen Sodium Receives Approval in the U.S.

    10 Jan 2023

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214463

    FDA
    10 Jan 2023
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    Neuvivo Begins Manufacture of ALS Treatment NP001
    Neuvivo Begins Manufacture of ALS Treatment NP001

    11 May 2022

    // CONTRACTPHARMA

    https://www.contractpharma.com/contents/view_breaking-news/2022-05-11/neuvivo-begins-manufacture-of-als-treatment-np001/?widget=listSection

    CONTRACTPHARMA
    11 May 2022
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    Oxcia contracts Patheon for manufacturing & further strengthens the organization
    Oxcia contracts Patheon for manufacturing & further strengthens the organization

    17 Jan 2022

    // CISION

    https://news.cision.com/oxcia-ab--publ-/r/oxcia-contracts-patheon-for-manufacturing-and-further-strengthens-the-organization,c3486875#:~:text=Oxcia%20contracts%20Patheon%20for%20manufacturing%20and%20further%20strengthens%20the%20organization,-Mon%2C%20Jan%2017&text=OXC%2D101%20is%20Oxcia's%20first,solid%20cancers%20or%20blood%20cancers.

    CISION
    17 Jan 2022
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    FDA Orange Book

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    01

    Brand Name : CHLOROTRIANISENE

    U.S.A
    Pharmaconex
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    Brand Name : CHLOROTRIANISENE

    U.S.A
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    RLD : No

    TE Code :

    CHLOROTRIANISENE

    Banner Pharmacap

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : CHLOROTRIANISENE

    Dosage Strength : 12MG

    Approval Date : 1982-01-01

    Application Number : 84652

    RX/OTC/DISCN : DISCN

    RLD : No

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    02

    Brand Name : CLOFIBRATE

    U.S.A
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    Brand Name : CLOFIBRATE

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    RLD : No

    TE Code :

    CLOFIBRATE

    Banner Pharmacap

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : CLOFIBRATE

    Dosage Strength : 500MG

    Approval Date : 1992-03-20

    Application Number : 73396

    RX/OTC/DISCN : DISCN

    RLD : No

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    Brand Name : ETHCHLORVYNOL

    U.S.A
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    Brand Name : ETHCHLORVYNOL

    U.S.A
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    RLD : No

    TE Code :

    ETHCHLORVYNOL

    Banner Pharmacap

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : ETHCHLORVYNOL

    Dosage Strength : 100MG

    Approval Date : 1982-01-01

    Application Number : 84463

    RX/OTC/DISCN : DISCN

    RLD : No

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    Brand Name : ETHCHLORVYNOL

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    Brand Name : ETHCHLORVYNOL

    U.S.A
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    RLD : No

    TE Code :

    ETHCHLORVYNOL

    Banner Pharmacap

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : ETHCHLORVYNOL

    Dosage Strength : 200MG

    Approval Date : 1982-01-01

    Application Number : 84463

    RX/OTC/DISCN : DISCN

    RLD : No

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    Brand Name : ETHCHLORVYNOL

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    Brand Name : ETHCHLORVYNOL

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    RLD : No

    TE Code :

    ETHCHLORVYNOL

    Banner Pharmacap

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : ETHCHLORVYNOL

    Dosage Strength : 500MG

    Approval Date : 1982-01-01

    Application Number : 84463

    RX/OTC/DISCN : DISCN

    RLD : No

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    Brand Name : ETHCHLORVYNOL

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    Brand Name : ETHCHLORVYNOL

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    RLD : No

    TE Code :

    ETHCHLORVYNOL

    Banner Pharmacap

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : ETHCHLORVYNOL

    Dosage Strength : 750MG

    Approval Date : 1982-01-01

    Application Number : 84463

    RX/OTC/DISCN : DISCN

    RLD : No

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    07

    Brand Name : IBUPROFEN

    U.S.A
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    Brand Name : IBUPROFEN

    U.S.A
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    Not Confirmed
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    RLD : No

    TE Code :

    IBUPROFEN

    Patheon

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : IBUPROFEN

    Dosage Strength : EQ 200MG FREE ACID AND P...

    Approval Date : 2024-02-13

    Application Number : 217236

    RX/OTC/DISCN : OTC

    RLD : No

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    Brand Name : NAPROXEN SODIUM

    U.S.A
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    Brand Name : NAPROXEN SODIUM

    U.S.A
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    RLD : No

    TE Code :

    NAPROXEN SODIUM

    Patheon

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : NAPROXEN SODIUM

    Dosage Strength : EQ 200MG BASE

    Approval Date : 2023-01-10

    Application Number : 214463

    RX/OTC/DISCN : OTC

    RLD : No

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    Brand Name : VITAMIN A

    U.S.A
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    Brand Name : VITAMIN A

    U.S.A
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    RLD : No

    TE Code :

    VITAMIN A

    Banner Pharmacap

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : VITAMIN A

    Dosage Strength : 50,000USP UNITS

    Approval Date : 1982-01-01

    Application Number : 83973

    RX/OTC/DISCN : DISCN

    RLD : No

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    10

    Brand Name : VITAMIN A PALMITATE

    U.S.A
    Pharmaconex
    Not Confirmed
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    Brand Name : VITAMIN A PALMITATE

    U.S.A
    Pharmaconex
    Not Confirmed
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    RLD : No

    TE Code :

    VITAMIN A PALMITATE

    Banner Pharmacap

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : VITAMIN A PALMITATE

    Dosage Strength : EQ 50,000 UNITS BASE

    Approval Date : 1982-01-01

    Application Number : 83948

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    Europe

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    Brand Name : Ibuprofen Banner Pha...

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    Brand Name : Ibuprofen Banner Pha...

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    Regulatory Info :

    Registration Country : Sweden

    ibuprofen

    Banner Pharmacap

    Dosage Form : SOFT CAPSULE

    Dosage Strength : 200 MG

    Packaging :

    Brand Name : Ibuprofen Banner Pharmacaps

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    01

    MANUFACTURING SITE, FACILITIES, PER...

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

    CPHI Shenzhen
    Not Confirmed
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    MANUFACTURING SITE, FACILITIES, PER...

    U.S.A

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

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    CPHI Shenzhen
    Not Confirmed
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 3002

    Submission : 1977-07-20

    Status : Inactive

    Type : IV

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

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    01

    MANUFACTURING SITE, FACILITI...

    Pharmaconex
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    MANUFACTURING SITE, FACILITI...

    U.S.A
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    Pharmaconex
    Not Confirmed
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    Banner Pharmacap

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 3002

    Submission : 1977-07-20

    Status : Inactive

    Type : IV

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    Inspections and registrations

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    FDA

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    01

    FDA Audited

    USA
    CPHI Shenzhen
    Not Confirmed
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    FDA Audited

    USA
    arrow
    CPHI Shenzhen
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2017-08-11

    Patheon

    City : High Point

    State : NC

    Country/Area : U.S.A

    Zip : 27265-8144

    District : ATL

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2017-08-11

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    02

    FDA Audited

    USA
    CPHI Shenzhen
    Not Confirmed
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    FDA Audited

    USA
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    CPHI Shenzhen
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2017-04-20

    Patheon

    City : Greenville

    State : NC

    Country/Area : U.S.A

    Zip : 27834-8628

    District : ATL

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2017-04-20

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    03

    FDA Audited

    USA
    CPHI Shenzhen
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    FDA Audited

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    CPHI Shenzhen
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-03-02

    Patheon

    City : Cincinnati

    State : OH

    Country/Area : U.S.A

    Zip : 45237-1625

    District : CIN

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-03-02

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    04

    FDA Audited

    USA
    CPHI Shenzhen
    Not Confirmed
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    FDA Audited

    USA
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    CPHI Shenzhen
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-09-03

    Patheon

    City : Manati

    State : PR

    Country/Area : U.S.A

    Zip : 674

    District : SJN

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-09-03

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    05

    FDA Audited

    USA
    CPHI Shenzhen
    Not Confirmed
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    FDA Audited

    USA
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    CPHI Shenzhen
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2015-02-13

    Patheon

    City : Princeton

    State : NJ

    Country/Area : U.S.A

    Zip : 8540

    District : NWJ

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2015-02-13

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    06

    FDA Audited

    USA
    CPHI Shenzhen
    Not Confirmed
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    FDA Audited

    USA
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    CPHI Shenzhen
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-01-30

    Patheon

    City : Mississauga

    State :

    Country/Area : Canada

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-01-30

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    07

    FDA Audited

    USA
    CPHI Shenzhen
    Not Confirmed
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    FDA Audited

    USA
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    CPHI Shenzhen
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2015-01-29

    Banner Pharmacap

    City : High Point

    State : NC

    Country/Area : U.S.A

    Zip : 27265-8144

    District : ATL

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2015-01-29

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    08

    FDA Audited

    USA
    CPHI Shenzhen
    Not Confirmed
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    FDA Audited

    USA
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    CPHI Shenzhen
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2015-01-28

    Patheon

    City : Capua

    State :

    Country/Area : Italy

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2015-01-28

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    09

    FDA Audited

    USA
    CPHI Shenzhen
    Not Confirmed
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    FDA Audited

    USA
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    CPHI Shenzhen
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2014-11-26

    Patheon

    City : Greenville

    State : SC

    Country/Area : U.S.A

    Zip : 29605

    District : ATL

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-11-26

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    10

    FDA Audited

    USA
    CPHI Shenzhen
    Not Confirmed
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    FDA Audited

    USA
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    CPHI Shenzhen
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2014-11-14

    Patheon

    City : Groningen

    State :

    Country/Area : Netherlands

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-11-14

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    EDQM

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    GMP Certified

    EU
    Pharmaconex
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    GMP Certified

    EU
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    Pharmaconex
    Not Confirmed

    Patheon

    Type : GMP Certificates

    Number : 6.2.2-2014-...

    EudraGMDP Key : 12295

    Country : U.S.A

    Issue Date : 2016-03-29

    Post Code : 674

    NCA Ref : 1.22951E+17

    City : Manati

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    02

    GMP Certified

    EU
    Pharmaconex
    Not Confirmed
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    GMP Certified

    EU
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    Pharmaconex
    Not Confirmed

    Patheon

    Type : GMP Certificates

    Number : NL/H 14/100...

    EudraGMDP Key : 11392

    Country : U.S.A

    Issue Date : 2016-02-05

    Post Code : MO 63134

    NCA Ref : PIF/12514

    City : St. Louis

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    03

    GMP Certified

    EU
    Pharmaconex
    Not Confirmed
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    GMP Certified

    EU
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    Pharmaconex
    Not Confirmed

    Patheon

    Type : GMP Certificates

    Number : UK MIA(IMP)...

    EudraGMDP Key : 6790

    Country : United Kingdom

    Issue Date : 2016-01-29

    Post Code : OX14 4SD

    NCA Ref : 14285-PATHEO...

    City : ABINGDON

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    04

    GMP Certified

    EU
    Pharmaconex
    Not Confirmed
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    GMP Certified

    EU
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    Pharmaconex
    Not Confirmed

    Patheon

    Type : GMP Certificates

    Number : NL/H 15/100...

    EudraGMDP Key : 14887

    Country : U.S.A

    Issue Date : 2015-12-21

    Post Code : NC 27834

    NCA Ref : PIF/14363

    City : Greenville, NC

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    05

    GMP Certified

    EU
    Pharmaconex
    Not Confirmed
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    GMP Certified

    EU
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    Pharmaconex
    Not Confirmed

    Patheon

    Type : GMP Certificates

    Number : NL/H 15/100...

    EudraGMDP Key : 10333

    Country : Netherlands

    Issue Date : 2015-11-17

    Post Code : 9744AP

    NCA Ref : FUSY/10370

    City : GRONINGEN

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    06

    GMP Certified

    EU
    Pharmaconex
    Not Confirmed
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    GMP Certified

    EU
    arrow
    Pharmaconex
    Not Confirmed

    Patheon

    Type : GMP Certificates

    Number : IT/166/H/20...

    EudraGMDP Key : 1719

    Country : Italy

    Issue Date : 2015-07-30

    Post Code : 20900

    NCA Ref : 1225

    City : MONZA

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    07

    GMP Certified

    EU
    Pharmaconex
    Not Confirmed
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    GMP Certified

    EU
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    Pharmaconex
    Not Confirmed

    Patheon

    Type : GMP Certificates

    Number : UK MIA 1785...

    EudraGMDP Key : 6592

    Country : United Kingdom

    Issue Date : 2015-07-17

    Post Code : SN3 5BZ

    NCA Ref : 10036-PATHEO...

    City : SWINDON

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    08

    GMP Certified

    EU
    Pharmaconex
    Not Confirmed
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    GMP Certified

    EU
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    Pharmaconex
    Not Confirmed

    Patheon

    Type : GMP Certificates

    Number : UK MIA(IMP)...

    EudraGMDP Key : 6592

    Country : United Kingdom

    Issue Date : 2015-07-17

    Post Code : SN3 5BZ

    NCA Ref : 10036-PATHEO...

    City : SWINDON

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    09

    GMP Certified

    EU
    Pharmaconex
    Not Confirmed
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    GMP Certified

    EU
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    Pharmaconex
    Not Confirmed

    Patheon

    Type : GMP Certificates

    Number : UK ManA 178...

    EudraGMDP Key : 6592

    Country : United Kingdom

    Issue Date : 2015-07-17

    Post Code : SN3 5BZ

    NCA Ref : 10036-PATHEO...

    City : SWINDON

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    10

    GMP Certified

    EU
    Pharmaconex
    Not Confirmed
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    GMP Certified

    EU
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    Pharmaconex
    Not Confirmed

    Patheon

    Type : GMP Certificates

    Number : NL/H 15/100...

    EudraGMDP Key : 10333

    Country : Netherlands

    Issue Date : 2015-07-09

    Post Code : 9744AP

    NCA Ref : FUSY/10370

    City : GRONINGEN

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    GDUFA

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    GDUFA fees paid

    USA
    Pharmaconex
    Not Confirmed
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    GDUFA fees paid

    USA
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    Pharmaconex
    Not Confirmed
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    Patheon

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer :

    Facility Name : Patheon API Manufacturing Inc.

    Business Address : 309 Delaware Street Greenvil...

    FEI Number : 3001451369

    Country : U.S.A

    Paid in : 2019

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    02

    GDUFA fees paid

    USA
    Pharmaconex
    Not Confirmed
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    GDUFA fees paid

    USA
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    Pharmaconex
    Not Confirmed
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    Patheon

    API Manufacturer :

    FDF Manufacturer :

    Facility Name : Patheon Inc.

    Business Address : 2100 Syntex Court Mississaug...

    FEI Number : 3000264888

    Country : U.S.A

    Paid in : 2019

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    03

    GDUFA fees paid

    USA
    Pharmaconex
    Not Confirmed
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    GDUFA fees paid

    USA
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    Pharmaconex
    Not Confirmed
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    Patheon

    API Manufacturer :

    FDF Manufacturer :

    Facility Name : Patheon Inc.

    Business Address : 111 Consumers Dr Whitby Onta...

    FEI Number : 3003516812

    Country : U.S.A

    Paid in : 2019

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    04

    GDUFA fees paid

    USA
    Pharmaconex
    Not Confirmed
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    GDUFA fees paid

    USA
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    Pharmaconex
    Not Confirmed
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    Patheon

    API Manufacturer :

    FDF Manufacturer :

    Facility Name : Patheon Italia S.p.A

    Business Address : Viale Gian Battista Stucchi ...

    FEI Number : 3003065803

    Country : U.S.A

    Paid in : 2019

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    05

    GDUFA fees paid

    USA
    Pharmaconex
    Not Confirmed
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    GDUFA fees paid

    USA
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    Pharmaconex
    Not Confirmed
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    Patheon

    API Manufacturer :

    FDF Manufacturer :

    Facility Name : Patheon Italia S.p.A

    Business Address : 2 Trav. SX Via Morolense, 5 ...

    FEI Number : 3004110157

    Country : U.S.A

    Paid in : 2019

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    06

    GDUFA fees paid

    USA
    Pharmaconex
    Not Confirmed
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    GDUFA fees paid

    USA
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    Pharmaconex
    Not Confirmed
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    Patheon

    API Manufacturer :

    FDF Manufacturer :

    Facility Name : Patheon Manufacturing Services...

    Business Address : 5900 Martin Luther King Jr H...

    FEI Number : 1018495

    Country : U.S.A

    Paid in : 2019

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    07

    GDUFA fees paid

    USA
    Pharmaconex
    Not Confirmed
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    GDUFA fees paid

    USA
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    Pharmaconex
    Not Confirmed
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    Patheon

    API Manufacturer :

    FDF Manufacturer :

    Facility Name : Patheon Pharmaceuticals Inc.

    Business Address : 2110 E. Galbraith Rd. Cincin...

    FEI Number : 1510437

    Country : U.S.A

    Paid in : 2019

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    08

    GDUFA fees paid

    USA
    Pharmaconex
    Not Confirmed
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    USA
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    Not Confirmed
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    Patheon

    API Manufacturer :

    FDF Manufacturer :

    Facility Name : Patheon Puerto Rico, Inc.

    Business Address : State Road #670 Km. 2.7 Mana...

    FEI Number : 3003113148

    Country : U.S.A

    Paid in : 2019

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    09

    GDUFA fees paid

    USA
    Pharmaconex
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    Not Confirmed
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    Paid in : 2019

    Banner Pharmacap

    API Manufacturer :

    FDF Manufacturer :

    Facility Name : Patheon Softgels Inc.

    Business Address : 4125 Premier Drive High Poin...

    FEI Number : 3001451366

    Country : U.S.A

    Paid in : 2019

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    ABOUT THIS PAGE

    Contact Patheon Pharmaceuticals Inc. and get a quotation

    Patheon Pharmaceuticals Inc. is a supplier offers 64 products (APIs, Excipients or Intermediates).

    Find a price of Pyridostigmine bulk with CEP, JDMF offered by Patheon Pharmaceuticals Inc.

    Find a price of Clodronic Acid Disodium Salt bulk with CEP offered by Patheon Pharmaceuticals Inc.

    Find a price of Fostamatinib Disodium Hexahydrate bulk with JDMF offered by Patheon Pharmaceuticals Inc.

    Find a price of Neostigmine Bromide bulk with JDMF offered by Patheon Pharmaceuticals Inc.

    Find a price of Neostigmine Methylsulfate bulk with CEP offered by Patheon Pharmaceuticals Inc.

    Find a price of Patiromer Sorbitex Calcium bulk with JDMF offered by Patheon Pharmaceuticals Inc.

    Find a price of Vitamin E bulk with JDMF offered by Patheon Pharmaceuticals Inc.

    Find a price of Latanoprost bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of MANUFACTURING SITE, FACILITIES AND PERSONNEL IN FORT ERIE, ONTARIO, CANADA bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MISSISSAUGA, ONTARIO, CANADA. bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BURLINGTON, ONTARIO, CANADA. bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Abatacept bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Acetazolamide Sodium bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Alteplase bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Aminolevulinic Acid Hexylester bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Bivalirudin bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Cangrelor bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Capecitabine bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Caplacizumab bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Carfilzomib bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Certolizumab Pegol bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Coagulation Factor Ix Recombinant bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Colesevelam Hydrochloride bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Colistimethate Sodium bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Daptomycin bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Delafloxacin Meglumine bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Elotuzumab bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Eravacycline Dihydrochloride bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Etanercept bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Ethacrynate Sodium bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Fosaprepitant bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Glycerol Phenylbutyrate bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Imetelstat bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Indocyanine Green bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Infliximab bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Luspatercept bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Melphalan Hydrochloride bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Omadacycline bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Opicapone bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Oritavancin bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Oritavancin Diphosphate bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Oseltamivir Phosphate bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Pantoprazole Sodium bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Phloroglucinol bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Remdesivir bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Remimazolam Besylate bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Rezafungin bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Risperidone bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Semaxanib bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Sodium Phenylbutyrate bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Sotatercept bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Tedizolid bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Thrombin bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Ticagrelor bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Tigecycline bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Tobramycin Sulfate bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Trastuzumab bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Triamcinolone Acetonide bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Trimethyl Phloroglucinol bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Vedolizumab bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Vigabatrin bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of EFMOROCTOCOG ALFA bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of Ojanimode bulk offered by Patheon Pharmaceuticals Inc.

    Find a price of BASILIXIMAB bulk offered by Patheon Pharmaceuticals Inc.

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