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    Company profile for Catalent Pharma Solutions

    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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    LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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    Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.

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    Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.

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    Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.

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    Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

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    About

    We are a global leader in providing integrated services, superior drug delivery technologies & manufacturing solutions to help life science innovators develop & launch successful pharmaceuticals, biologics and consumer health products, enabling a better customer journey from product development to patient. With over 85 years of experience in the industry, Catalent supports partners in introducing 200 new products and manufactu...
    We are a global leader in providing integrated services, superior drug delivery technologies & manufacturing solutions to help life science innovators develop & launch successful pharmaceuticals, biologics and consumer health products, enabling a better customer journey from product development to patient. With over 85 years of experience in the industry, Catalent supports partners in introducing 200 new products and manufacturing over 70 billion doses/year. We have grown to become a vibrant community of approximately 15,000 employees, including around 2,400 scientists and technicians, supporting over 7,000 products for over 1,000 customers.

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    Catalent Pharma SolutionsUnited_States_of_America Flag
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    14 Schoolhouse Road, Somerset, NJ 08873
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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 

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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]

    ReelPharmaIngredients for Innovative FormulationsIngredients for Innovative Formulations

    Ingredients for Innovative Formulations
    Ingredients for Innovative Formulations

    reelIngredients for Innovative Formulations

    This PharmaReel highlights Kirsch Pharma’s expertise in providing premium quality raw materials, custom blends, and tailor-made solutions. With 40+ years of expertise and certified quality (GMP, ISO 9001, FSSC 22000, Halal, Kosher), Kirsch supports pharma, biotech, and nutrition industries worldwide.

    Impressions: 1289

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    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    Global API micronization market set to surge 49% by 2030, led by specialized industry pioneers

    Global API micronization market set to surge 49% by 2030, led by specialized industry pioneers

    Precise particle size control has become the cornerstone of modern pharmaceutical manufacturing. With highly potent active pharmaceutical ingredients (HPAPIs) and complex formulations driving unprecedented demand, micronization technology is no longer optional — it's critical. The market reflects this urgency. The global API micronization market will jump from US$ 2.47 billion in 2024 to US$ 3.68 billion by 2030 — a 49 percent surge driven by a robust 6.84 percent CAGR. What's powering this growth? Strategic innovation by industry leaders. Companies like Munit SA, Lonza, Catalent, Veranova, EUROAPI, AGC Pharma Chemicals, Hovione and Coral Drugs aren't just participating — they're defining the future of pharmaceutical particle engineering. The Micronization Landscape: How leading companies are advancing pharmaceutical particle engineering The API micronization space is being shaped by companies with specialized expertise. Munit’s proprietary fluid jet milling technology brings particle sizes down to the 1-micron level — critical for inhalation therapies. In addition, this technology enables precise control over particle size distribution without mechanical impact, making it ideal for heat-sensitive and high-potency APIs. With decades of hands-on experience, Munit ensures batch-to-batch consistency, scalability from R&D to commercial volumes, and full compliance with GMP standards.  Munit offers high-containment isolators — including glove boxes for R&D and half-suit isolators for larger batches — with industry-leading containment levels, limiting airborne drug exposure to as low as 0.025 micrograms per cubic meter. This makes it particularly well-suited for handling highly potent or sensitive compounds, exceeding the capabilities of other commercial-scale players like Catalent, who typically achieve containment levels of 0.05 micrograms per cubic meter or higher. EUROAPI has taken a broad particle engineering approach, offering both micronization and spray drying across multiple dosage routes — oral, inhaled, and parenteral. AGC Pharma Chemical leverages spray drying and amorphous solid dispersion technologies across small molecules, peptides, ADCs, and oligonucleotides, exemplifying the evolving intersection of particle engineering and modern drug delivery innovation. Coral Drugs delivers cutting-edge technology and customization capabilities that tailor particle sizes to specific client requirements across tablets, injectables, and topicals. This dynamic competitive landscape continues to evolve as companies expand capabilities and form strategic partnerships. This year, Dec Group announced the launch of their cutting-edge Micronization Suite, now operational in Brick, New Jersey, while Lonza joined the Centre for Continuous Manufacturing and Advanced Crystallisation, an international research hub, to develop innovative continuous processing and crystallization solutions. Selecting the right micronization partner: Key success factors In a pharmaceutical landscape increasingly defined by complexity, precision, and speed-to-market, the choice of a micronization partner can significantly influence a drug’s success. Among the players in this space, Munit SA has emerged as a trusted and strategic ally for pharmaceutical companies worldwide. But what exactly sets Munit apart in the micronization market? To begin with, Munit SA brings over 60 years of experience in particle size engineering. This legacy is not just a number; it reflects decades of accumulated knowledge, process refinement, and a deep understanding of how particle size impacts drug performance. In an industry where even minor deviations can compromise efficacy or safety, this level of experience is invaluable. It has delivered over 500 successful micronization projects to more than 150 customers globally. At its core, Munit SA is laser-focused on micronization and milling — not as ancillary services, but as its primary mission. Their facilities are designed for processing high-potency APIs, cytotoxic and cytostatic compounds, non-beta-lactam antibiotics, steroids, and controlled substances under stringent containment protocols. The company also handles inhalation products, peptides, biological drugs, generics, and R&D compounds. Whether it's micronization for ophthalmic formulations, transdermal or oral products, Munit offers a tailored approach. It stands as a world-leading provider of micronization services in inhalation powders with particle sizes of 1-5 microns and specialized oncology applications for small molecules. In an increasingly complex global landscape, Munit SA addresses supply chain challenges through its dual-site operational model, with facilities in Switzerland (Jetpharma SA) and Italy (Microchem S.r.l). This strategic setup mitigates risks from regulatory changes, geopolitical tensions, or environmental disruptions, ensuring continuous production and delivery of critical APIs. This resilience makes Munit a trusted partner for companies prioritizing business continuity. Why pharmaceutical companies choose Munit for advanced micronization and milling Munit’s proprietary MC Jet Mill is a testament to its engineering excellence. For heat-sensitive APIs, Munit’s cryogenic micronization process uses liquid nitrogen to cool materials, preventing thermal degradation and preserving the integrity of delicate molecules. This is particularly valuable for biologics and APIs with low melting points, where stability is paramount. Additionally, Munit’s under containment micronization employs advanced systems to safely handle HPAPIs, protecting both operators and the environment while meeting stringent regulatory standards.  Their co-micronization service, which processes APIs alongside excipients, further enhances formulation stability and solubility, offering innovative solutions for complex drug profiles. These capabilities, executed under Good Manufacturing Practices (GMP), make Munit a reliable choice for pharmaceutical companies seeking precision and quality. While micronization is Munit’s flagship, it offers milling services through an array of technologies, each suited to specific needs. The Pin Mill uses a grinding chamber and particle size reduction is achieved due impact against a high-speed pin rotor, producing sizes from 50 to 150 microns. It’s particularly effective for APIs needing improved flow for tableting, offering precise size control that ensures uniformity. The Quadro Co-Mill excels at soft de-lumping and homogenization, using a conical sieve and impeller to gently process powders without altering primary particle sizes. For tougher materials, the HammerMill C-10 employs hammer bars on a rotor to crush particles. State-of-the-Art Particle Engineering: Munit's strategic innovation push delivers next-gen solutions Munit’s leadership in micronization is underpinned by a deliberate and sustained investment in innovation — aimed at building the next generation of particle size engineering. In response to client challenges with condensation and product degradation, Munit developed a proprietary conditioning system that precisely controls humidity and temperature. Engineered with ergonomic design and fluid dynamics principles, their machine represents a qualitative leap in conditioning. Munit's new AIFA-approved Building C transforms the Italian hub's capacity. Equipped for high potent, toxic, cytotoxic, and cytostatic compounds, alongside hormones, it features cutting-edge safety systems and integrated technologies, enabling broader API processing with precision and compliance. Munit has merged quality assurance and regulatory affairs into one strategic unit, streamlining workflows and enhancing client responsiveness during critical validation phases. This delivers tailored regulatory support and accelerates time-to-market. These initiatives position Munit at the forefront of particle size engineering, where state-of-the-art innovation, regulatory excellence, and client-centric design converge to set new industry standards. Our view The API micronization market is projected to grow 49 percent to US$ 3.68 billion by 2030. In this evolving landscape, companies that combine deep technical expertise with operational resilience are positioned to capture the greatest value. Munit SA exemplifies this winning formula.
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    Impressions: 2758

    https://www.pharmacompass.com/radio-compass-blog/global-api-micronization-market-set-to-surge-49-by-2030-led-by-specialized-industry-pioneers

    #Phispers by PHARMACOMPASS
    10 Sep 2025
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    NEWS #PharmaBuzz

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    Science 37, Catalent Partner for Universal Clinical Research
    Science 37, Catalent Partner for Universal Clinical Research

    04 Sep 2025

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2025/09/04/3144421/0/en/Science-37-and-Catalent-Announce-Partnership-Enabling-Universal-Access-to-Clinical-Research.html

    GLOBENEWSWIRE
    04 Sep 2025
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    Catalent's Newly Acquired Novo Plant Under FDA Scrutiny
    Catalent's Newly Acquired Novo Plant Under FDA Scrutiny

    22 Aug 2025

    // FIERCE PHARMA

    https://www.fiercepharma.com/manufacturing/novo-plant-acquired-catalent-buyout-faces-renewed-fda-scrutiny-form-483-stat

    FIERCE PHARMA
    22 Aug 2025
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    Catalent Cuts 350 Jobs in Maryland
    Catalent Cuts 350 Jobs in Maryland

    20 Aug 2025

    // FIERCE PHARMA

    https://www.fiercepharma.com/manufacturing/catalent-lays-350-gene-therapy-manufacturing-facilities-maryland

    FIERCE PHARMA
    20 Aug 2025
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    GenSight Biologics Reaches Milestone in Partnership with Catalent
    GenSight Biologics Reaches Milestone in Partnership with Catalent

    26 Jun 2025

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20250625927844/en/GenSight-Biologics-Announces-Significant-Milestone-in-New-Manufacturing-Partnership-with-Catalent

    BUSINESSWIRE
    26 Jun 2025
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    Silexion Collaborates with Catalent on siRNA Development
    Silexion Collaborates with Catalent on siRNA Development

    23 Apr 2025

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2025/04/23/3066491/0/en/Silexion-Therapeutics-Announces-Collaboration-with-Global-Therapeutics-Leader-Catalent-on-Advanced-siRNA-Formulation-Development-Clinical-Manufacturing-Activities.html

    GLOBENEWSWIRE
    23 Apr 2025
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    Zelluna achieves milestone with manufacturing process for ZI-MA4-
    Zelluna achieves milestone with manufacturing process for ZI-MA4-

    22 Apr 2025

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2025/04/22/3065134/0/en/Zelluna-Reaches-Major-Milestone-with-Manufacturing-Process-Established-in-Preparation-for-Clinical-Entry-of-ZI-MA4-1-its-Novel-TCR-NK-Therapy-Targeting-Solid-Tumours.html

    GLOBENEWSWIRE
    22 Apr 2025
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    FDF Dossiers

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    Brand Name : CETIRIZINE HYDROCHLO...

    U.S.A
    Cell Therapy
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    Brand Name : CETIRIZINE HYDROCHLO...

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    Regulatory Info : OTC

    Registration Country : USA

    CETIRIZINE HYDROCHLORIDE

    Catalent Pharma Solutions

    Dosage Form : CAPSULE;ORAL

    Brand Name : CETIRIZINE HYDROCHLORIDE ...

    Dosage Strength : 10MG

    Packaging :

    Approval Date : 2020-09-21

    Application Number : 213105

    Regulatory Info : OTC

    Registration Country : USA

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    Brand Name : LORATADINE

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    Brand Name : LORATADINE

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    Regulatory Info : DISCN

    Registration Country : USA

    LORATADINE

    Catalent Pharma Solutions

    Dosage Form : CAPSULE;ORAL

    Brand Name : LORATADINE

    Dosage Strength : 10MG

    Packaging :

    Approval Date : 2025-02-28

    Application Number : 215127

    Regulatory Info : DISCN

    Registration Country : USA

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    03

    Brand Name : NAPROXEN SODIUM

    U.S.A
    Cell Therapy
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    Brand Name : NAPROXEN SODIUM

    U.S.A
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    Regulatory Info : OTC

    Registration Country : USA

    NAPROXEN SODIUM

    Catalent Pharma Solutions

    Dosage Form : CAPSULE;ORAL

    Brand Name : NAPROXEN SODIUM

    Dosage Strength : EQ 200MG BASE

    Packaging :

    Approval Date : 2019-01-04

    Application Number : 202807

    Regulatory Info : OTC

    Registration Country : USA

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    Brand Name : VALPROIC ACID

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    Brand Name : VALPROIC ACID

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    Regulatory Info : RX

    Registration Country : USA

    VALPROIC ACID

    Catalent Pharma Solutions

    Dosage Form : CAPSULE;ORAL

    Brand Name : VALPROIC ACID

    Dosage Strength : 250MG

    Packaging :

    Approval Date : 1991-10-29

    Application Number : 73229

    Regulatory Info : RX

    Registration Country : USA

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    FDA Orange Book

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    Brand Name : CETIRIZINE HYDROCHLO...

    U.S.A
    Boulder Peptide
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    Brand Name : CETIRIZINE HYDROCHLO...

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    RLD : No

    TE Code :

    CETIRIZINE HYDROCHLORIDE

    Catalent Pharma Solutions

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : CETIRIZINE HYDROCHLORIDE...

    Dosage Strength : 10MG

    Approval Date : 2020-09-21

    Application Number : 213105

    RX/OTC/DISCN : OTC

    RLD : No

    TE Code :

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    Brand Name : LORATADINE

    U.S.A
    Boulder Peptide
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    Brand Name : LORATADINE

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    Boulder Peptide
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    RLD : No

    TE Code :

    LORATADINE

    Catalent Pharma Solutions

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : LORATADINE

    Dosage Strength : 10MG

    Approval Date : 2025-02-28

    Application Number : 215127

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    Brand Name : NAPROXEN SODIUM

    U.S.A
    Boulder Peptide
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    Brand Name : NAPROXEN SODIUM

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    Boulder Peptide
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    RLD : No

    TE Code :

    NAPROXEN SODIUM

    Catalent Pharma Solutions

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : NAPROXEN SODIUM

    Dosage Strength : EQ 200MG BASE

    Approval Date : 2019-01-04

    Application Number : 202807

    RX/OTC/DISCN : OTC

    RLD : No

    TE Code :

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    Brand Name : VALPROIC ACID

    U.S.A
    Boulder Peptide
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    Brand Name : VALPROIC ACID

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    RLD : No

    TE Code : AB

    VALPROIC ACID

    Catalent Pharma Solutions

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : VALPROIC ACID

    Dosage Strength : 250MG

    Approval Date : 1991-10-29

    Application Number : 73229

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Inspections and registrations

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    FDA

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    FDA Audited

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    Boulder Peptide
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    Boulder Peptide
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    District Decision : Official Action Indicated

    Inspection End Date : 2020-09-28

    Catalent Pharma Solutions

    City : Morrisville

    State : NC

    Country/Area : U.S.A

    Zip : 27560-9570

    District : ATL

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Official Action Indicated

    Inspection End Date : 2020-09-28

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    Boulder Peptide
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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2020-02-20

    Catalent Pharma Solutions

    City : Swindon

    State :

    Country/Area : United Kingdom

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2020-02-20

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    03

    FDA Audited

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    Not Confirmed
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    USA
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    Boulder Peptide
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2020-02-14

    Catalent Pharma Solutions

    City : Schorndorf

    State :

    Country/Area : Germany

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2020-02-14

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    04

    FDA Audited

    USA
    Boulder Peptide
    Not Confirmed
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    FDA Audited

    USA
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    Boulder Peptide
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2020-01-22

    Catalent Pharma Solutions

    City : Brussels

    State :

    Country/Area : Belgium

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2020-01-22

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    05

    FDA Audited

    USA
    Boulder Peptide
    Not Confirmed
    arrow

    FDA Audited

    USA
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    Boulder Peptide
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2019-12-20

    Catalent Pharma Solutions

    City : Morrisville

    State : NC

    Country/Area : U.S.A

    Zip : 27560-9570

    District : ATL

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2019-12-20

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    06

    FDA Audited

    USA
    Boulder Peptide
    Not Confirmed
    arrow

    FDA Audited

    USA
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    Boulder Peptide
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2019-11-04

    Catalent Pharma Solutions

    City : Baltimore

    State : MD

    Country/Area : U.S.A

    Zip : 21201-1190

    District : BLT

    Center : CBER

    Project Area : Human Cellular, Tissue, and Gene...

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2019-11-04

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    07

    FDA Audited

    USA
    Boulder Peptide
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Boulder Peptide
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2019-10-18

    Catalent Pharma Solutions

    City : Bloomington

    State : IN

    Country/Area : U.S.A

    Zip : 47403-4828

    District : DET

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2019-10-18

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    08

    FDA Audited

    USA
    Boulder Peptide
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Boulder Peptide
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2019-10-11

    Catalent Pharma Solutions

    City : Nottingham

    State :

    Country/Area : United Kingdom

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2019-10-11

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    09

    FDA Audited

    USA
    Boulder Peptide
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Boulder Peptide
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2019-08-28

    Catalent Pharma Solutions

    City : Saint Petersburg

    State : FL

    Country/Area : U.S.A

    Zip : 33716-1016

    District : FLA

    Center : CDRH

    Project Area : Compliance: Devices

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2019-08-28

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    10

    FDA Audited

    USA
    Boulder Peptide
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Boulder Peptide
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2019-06-19

    Catalent Pharma Solutions

    City : Brussels

    State :

    Country/Area : Belgium

    Zip :

    District : ORA

    Center : CBER

    Project Area : Vaccines and Allergenic Products

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2019-06-19

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    EDQM

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    01

    GMP Certified

    EU
    Boulder Peptide
    Not Confirmed
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    GMP Certified

    EU
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    Boulder Peptide
    Not Confirmed

    Catalent Pharma Solutions

    Type : GMP Certificates based on a Distant Assessment

    Number : FT085/SA/00...

    EudraGMDP Key : 115702

    Country : U.S.A

    Issue Date : 2021-01-21

    Post Code : 21077

    NCA Ref : 109230161122...

    City : Harmans

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    02

    GMP Certified

    EU
    Boulder Peptide
    Not Confirmed
    arrow

    GMP Certified

    EU
    arrow
    Boulder Peptide
    Not Confirmed

    Catalent Pharma Solutions

    Type : GMP Certificates

    Number : 2021/hPF/FR...

    EudraGMDP Key : 115104

    Country : France

    Issue Date : 2021-01-15

    Post Code : 67930

    NCA Ref : 622017077000...

    City : BEINHEIM

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    03

    GMP Certified

    EU
    Boulder Peptide
    Not Confirmed
    arrow

    GMP Certified

    EU
    arrow
    Boulder Peptide
    Not Confirmed

    Catalent Pharma Solutions

    Type : GMP Certificates

    Number : 2021/HPF/FR...

    EudraGMDP Key : 115067

    Country : France

    Issue Date : 2021-01-15

    Post Code : 67930

    NCA Ref : 622017077000...

    City : BEINHEIM

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    04

    GMP Certified

    EU
    Boulder Peptide
    Not Confirmed
    arrow

    GMP Certified

    EU
    arrow
    Boulder Peptide
    Not Confirmed

    Catalent Pharma Solutions

    Type : GMP Certificates

    Number : DE_BW_01_GM...

    EudraGMDP Key : 113626

    Country : Germany

    Issue Date : 2020-12-18

    Post Code : 73614

    NCA Ref : 00015123

    City : Schorndorf

    blank

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    05

    GMP Certified

    EU
    Boulder Peptide
    Not Confirmed
    arrow

    GMP Certified

    EU
    arrow
    Boulder Peptide
    Not Confirmed

    Catalent Pharma Solutions

    Type : GMP Certificates

    Number : DE_BW_01_GM...

    EudraGMDP Key : 113624

    Country : Germany

    Issue Date : 2020-12-18

    Post Code : 73614

    NCA Ref : 00015123

    City : Schorndorf

    blank

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    06

    GMP Certified

    EU
    Boulder Peptide
    Not Confirmed
    arrow

    GMP Certified

    EU
    arrow
    Boulder Peptide
    Not Confirmed

    Catalent Pharma Solutions

    Type : GMP Certificates

    Number : IT/127/H/20...

    EudraGMDP Key : 112602

    Country : Italy

    Issue Date : 2020-12-16

    Post Code : 03012

    NCA Ref : 170415870305...

    City : ANAGNI (FR)

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    07

    GMP Certified

    EU
    Boulder Peptide
    Not Confirmed
    arrow

    GMP Certified

    EU
    arrow
    Boulder Peptide
    Not Confirmed

    Catalent Pharma Solutions

    Type : GMP Certificates

    Number : IT/127/H/20...

    EudraGMDP Key : 112603

    Country : Italy

    Issue Date : 2020-12-16

    Post Code : 03012

    NCA Ref : 170415870305...

    City : ANAGNI (FR)

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    Product
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    08

    GMP Certified

    EU
    Boulder Peptide
    Not Confirmed
    arrow

    GMP Certified

    EU
    arrow
    Boulder Peptide
    Not Confirmed

    Rheincell Therapeutics

    Type : GMP Certificates

    Number : DE_NW_03_GM...

    EudraGMDP Key : 112647

    Country : Germany

    Issue Date : 2020-12-16

    Post Code : 40764

    NCA Ref : 00051998

    City : Langenfeld

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    09

    GMP Certified

    EU
    Boulder Peptide
    Not Confirmed
    arrow

    GMP Certified

    EU
    arrow
    Boulder Peptide
    Not Confirmed

    Catalent Pharma Solutions

    Type : GMP Certificates

    Number : NBF/49/2020...

    EudraGMDP Key : 113164

    Country : Italy

    Issue Date : 2020-10-09

    Post Code : 03012

    NCA Ref : 183

    City : ANAGNI (Frosinone)

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    10

    GMP Certified

    EU
    Boulder Peptide
    Not Confirmed
    arrow

    GMP Certified

    EU
    arrow
    Boulder Peptide
    Not Confirmed

    Catalent Pharma Solutions

    Type : GMP Certificates

    Number : BE/GMP/2019...

    EudraGMDP Key : 98702

    Country : Belgium

    Issue Date : 2020-08-06

    Post Code : 6041

    NCA Ref : 228151389334...

    City : Gosselies

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