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About

At GSK we have a challenging mission: to improve the quality of human life by enabling people to do more, feel better, live longer. Find out how this shapes everything we do, including our R&D, our partnerships, our work with communities and our efforts to prevent and treat disease around the world. We are a science-led global healthcare company with a mission: we want to help people to do more, feel better, live longer. The...
At GSK we have a challenging mission: to improve the quality of human life by enabling people to do more, feel better, live longer. Find out how this shapes everything we do, including our R&D, our partnerships, our work with communities and our efforts to prevent and treat disease around the world. We are a science-led global healthcare company with a mission: we want to help people to do more, feel better, live longer. The vaccines, medicines and consumer healthcare products that we research and develop can improve people’s health and well-being, ultimately helping them to live life to its fullest and contribute.

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CONTACT DETAILS

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Country
Country
United Kingdom
Address
Address
980 Great West Road, Brentford, Middlesex TW8 9GS England
Telephone
Telephone
+44 (0)20 8047 5000
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Linkedin
Twitter
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INTERVIEW #SpeakPharma

[Sponsored by another company]
“We’re unlocking life-changing potential in complex molecules, without sacrificing time to market”
This week, SpeakPharma interviews Mike Riley, CEO of Veranova, a leading contract development and manufacturing organization (CDMO) confidently mastering complex APIs as it marks its second year as an independent company. Riley discusses Veranova’s key achievements, including a US$ 30 million investment in their Devens, Massachusetts (US) site to expand capabilities in antibody-drug conjugates (ADCs) and highly potent APIs (HPAPIs), and how it is navigating the increasing complexity of molecules. 🔑 HIGHLIGHTS// Veranova’s key achievements / navigating the increasing complexity of molecules Veranova is celebrating its second year as a stand-alone company. Can you share Veranova’s key milestones and achievements in its first two years? We have achieved incredible milestones over the last two years, thanks to the dedication and hard work of our team. Our first 12 months focused on establishing ourselves as an independent CDMO by building on the 50 years of expertise that we brought with us. In addition, we expanded our capabilities and applied a more agile approach available to us as a company singularly focused on life sciences. This has allowed us to move into our second year with clear and strategic goals for generating growth in our sites, people, capabilities, and offerings. Since being appointed as CEO in May 2023, I’ve had the pleasure of witnessing some exciting growth milestones of my own. Most recently, we announced an estimated US$ 30 million investment in our Devens, Massachusetts, site. This expansion will allow us to build upon existing development and manufacturing capabilities in ADCs and HPAPIs that will address the growing demand for strong US-based capacity in these key drug modalities. We also appointed our Advisory Board, thereby bolstering Veranova’s in-house expertise. Made up of four distinguished leaders in pharma and biopharma – including Dr. Carolyn Bertozzi, the 2022 Nobel Laureate in Chemistry – the Board has provided thought-leadership, guidance and expertise as we develop and execute our strategic growth and ideas. We were also proud to be recognized as one of the Society of Chemical Manufacturers and Affiliates’ 12 companies for industry-leading safety programs in 2023 and as a part of the Medicine Maker’s Power List in 2024. 🔑 HIGHLIGHTS// US$ 30 million investment in our Devens, Massachusetts, site / appointed our Advisory Board Molecules are becoming increasingly complex. Can you elaborate on how Veranova’s current capabilities are strategically designed to address this trend in the coming years? The pharmaceutical pipeline is witnessing an increasing number of complex and highly potent molecules. This trend is driven by the demand for more targeted, patient-centric therapeutics and the focus on innovative modalities such as ADCs and other bioconjugates. At Veranova, our expertise, world-class facilities, and scientific excellence enable us to provide our customers with the clarity and solutions needed to manage this development and manufacturing complexity and ultimately deliver the required treatments to customers and patients. Our people are key to this approach. We have an expert team ready to collaborate with customers at any point, from early development through large-scale commercial production. Our services include world-leading crystallization development, process development, and specialized manufacturing expertise for complex synthetic molecules, including those requiring chromatography capabilities. In many cases, we can provide all these under one roof. Our service offering to our customers is also based on the foundational element of strong quality and compliance systems. We operate multiple facilities approved by the US FDA, UK’s MHRA and other regulatory authorities and are continually focused on ways to strengthen our global quality management system. Looking ahead, we are focused on continually investing in our facilities and team to meet growing complexity, as evidenced by our recent announcement of new investment in our Devens site. This investment signals our commitment to providing state-of-the-art capacity and capabilities to enable these next-generation therapies to reach patients. It is a key milestone as we advance Veranova’s broader growth strategy. 🔑 HIGHLIGHTS// provide our customers with clarity and solutions / world-leading crystallization development / expertise for complex synthetic molecules / strong quality and compliance systems How is Veranova approaching the challenge of designing and manufacturing effective linker molecules for ADCs? As a leader in complex linker-payload synthesis, Veranova is committed to unlocking the life-changing potential of ADCs without letting their complexities slow down the development of much-needed cancer therapies. ADCs are intricate, multi-component molecules that require extensive expertise and agile collaboration to overcome unique development challenges. With over a decade of experience in ADC linker-payload systems, we have developed the ability to anticipate challenges and avoid common pitfalls. The ADC linker-payload components are complex structures that are difficult to crystallize and require specialized high-potent handling. Veranova’s differentiated combination of world-leading crystallization development capabilities, complex synthesis experience, chromatography expertise and high-potent-handling experience put us in a unique position to solve these challenges for customers and speed their products to the clinic. We prioritize getting it right the first time, minimizing change orders and ensuring high-quality results. We have developed a robust phase-appropriate strategy that is backed by state-of-the-art analytical equipment and regulatory procedures to ensure our partners can rapidly progress their ADC projects from pre-clinical to commercialization. 🔑 HIGHLIGHTS// unlocking the life-changing potential of ADCs / ensuring our partners can rapidly progress their ADC projects Can you specify how Veranova is using artificial intelligence (AI) to optimize manufacturing processes that can reduce costs and environmental footprint as well as speed up development? In May 2024, Veranova announced a partnership with Phorum.AI to leverage AI to optimize pharmaceutical manufacturing processes. This collaboration aims to enable the rapid development of processes that can drive efficiency and reduce costs while maximizing environmental sustainability. Our goal is to combine Veranova’s extensive empirical manufacturing dataset of owned APIs and drug master files with Phorum.AI’s computational chemistry engine in order to create a more powerful process-development tool for the benefit of Veranova’s and Phorum’s customers. At Veranova, we are constantly looking to employ innovative technologies and approaches to improve efficiency, accelerate time to market and reduce environmental footprint. We have the means to work with a variety of partners who have unique project requirements, without sacrificing time to market.  🔑 HIGHLIGHTS// partnership with Phorum.AI / create a more powerful process-development tool / improve efficiency, accelerate time to market and reduce environmental footprint

Impressions: 1659

https://www.pharmacompass.com/speak-pharma/we-re-unlocking-life-changing-potential-in-complex-molecules-without-sacrificing-time-to-market

#SpeakPharma With Veranova
10 Sep 2024

VLOG #PharmaReel

[Sponsored by another company]

DATA COMPILATION #PharmaFlow

[Sponsored by another company]
Excipient Market Overview: Roquette, Seqens, Evonik make strategic moves; new guidelines deal with contamination
The pharmaceutical industry has long recognized the critical role excipients or inactive ingredients play in drug formulation and delivery. Excipients can comprise up to 90 percent of a medicine's total ingredients and serve crucial functions as binders, disintegrants, coatings, preservatives, colors, and flavorings. According to recent market research, the pharmaceutical excipients market was valued at US$ 9.27 billion in 2023. It is growing at a compound annual growth rate (CAGR) of 7.03 percent and is projected to reach US$ 18.48 billion by 2032. The main factors driving market growth is an increased demand for multifunctional excipients, coupled with the expanding use of generic medications. The development in the biologics sector and advancements in nanotechnology are also contributing significantly to market growth. Major excipient providers include BASF, Evonik, Merck KGaA owned MilliporeSigma, Gangwal Healthcare, Roquette Frères, DuPont, Croda International, Seqens, Boai NKY Pharmaceuticals, PMC Isochem, Minakem, Kewpie Corporation, Ashland Global, SPI Pharma, Pfanstiehl, Nanjing Well Pharmaceutical, ICE Pharma, Anhui Ribobay Pharmaceutical and Nippon Fine Chemical.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) WHO, India’s CDSCO tighten regulations; new GMP guidelines implemented to curb contamination Last year, the World Health Organization (WHO) issued a health alert linking at least 300 child deaths in the Gambia, Uzbekistan, and Indonesia to the ingestion of contaminated cough syrups containing unacceptable levels of diethylene glycol (DEG) and ethylene glycol (EG). In response to the tragic events, the WHO released two draft appendices to its guideline on good manufacturing practices (GMPs) for excipients this year. Manufacturers are now required to use suitable risk assessment tools to identify and mitigate potential hazards.  Since India-made cough syrups had been linked to the deaths, India’s drug regulator — Central Drugs Standard Control Organization (CDSCO) — took steps to prevent contamination, and advised drugmakers to only use pharmaceutical-grade excipients from approved sources. Furthermore, the Indian Health Ministry proposed amendments to the Drugs and Cosmetics Rules, 1945 to include details of excipients on drug labels. While listing all excipients on every strip of medicine may be challenging, the ministry suggested mentioning those causing hypersensitivity on the label. Applicants now mandatorily need to submit evidence of stability and safety of excipients. These regulatory developments have significant implications for excipient manufacturers and pharmaceutical companies worldwide. Leading pharmaceutical excipient firms like Gangwal Healthcare, Sigachi Industries, and Nitika Pharmaceuticals are well-positioned to meet these heightened quality and safety standards, given their long-standing commitment to producing high-quality, compliant excipients.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Roquette buys IFF’s pharma unit for US$ 2.85 bn; Evonik opens new spray-drying facility in Darmstadt In a significant industry move, France-based Roquette entered into an agreement to acquire IFF's pharma solutions business in a deal valued at US$ 2.85 billion. This acquisition is set to rebalance family-owned Roquette’s portfolio around health and nutrition. The deal is expected to accelerate Roquette’s growth and significantly strengthen its presence in the excipients market. Evonik has opened a new facility for drying aqueous dispersions of its Eudragit polymers at its site in Darmstadt, Germany. The facility will help Evonik meet increasing demand from drugmakers for its oral drug delivery solutions. The plant uses green energy solutions. The company has also partnered University of Mainz to commercialize a new class of polyethylene glycols (PEG) lipids for nucleic acid delivery. Evonik’s Health Care business has been growing its nucleic acid drug and vaccine delivery portfolio.  Germany’s Johannes Gutenberg University of Mainz was the first to develop randomized polyethylene glycols (rPEGs). This collaboration aims to expand Evonik’s toolbox of technologies for nucleic acid-based medicines, offering an improved immunogenicity profile for lipid nanoparticle carriers used in mRNA vaccines and therapeutics. Asahi Kasei made significant strides in addressing a pressing industry concern that emerged in 2018 when potentially carcinogenic nitrosamine impurities were detected in several pharmaceuticals. Guided by regional authorities, such as the European Medicines Agency and the US Food and Drug Administration, the pharmaceutical industry has been carrying out extensive assessments and research to identify the cause of these impurities. In response to this challenge, Asahi Kasei developed its Ceolus microcrystalline cellulose with extremely low nitrite levels. The Japanese company achieved nitrite concentrations of 0.1 micrograms per gram or less, which is equivalent to 0.1 parts per million (ppm). The company also started full commercial operation of its second manufacturing facility for Ceolus in Japan, enhancing supply capacity and stability. JRS Pharma and Gujarat Microwax opened a state-of-the-art cotton-based croscarmellose sodium plant in Mehsana, Gujarat (India). This facility aims to produce high-quality excipients that meet global standards, potentially reducing India's dependency on imports and boosting its presence in the global excipient market. The Indian excipient industry accounts for less than 1 percent of the global market share.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Seqens to advance innovative polymer; biologics, personalized medicine create demand for specialized excipients Recent industry collaborations highlight the ongoing innovation in novel excipients. France’s Seqens, with over 20 years of polymer development experience, was chosen by Pleryon Therapeutics to advance its leading osteoarthritis candidate – an innovative GMP polymer. This collaboration leverages Seqens’ newly expanded and modernized cGMP plant in Aramon, France, demonstrating the industry’s commitment to investing in advanced manufacturing capabilities for novel excipients.  The rise of biologics and personalized medicine has created a demand for specialized excipients capable of stabilizing complex molecules and enabling targeted drug delivery. Roquette’s launch of Lycagel Flex, a hydroxypropyl pemix for nutraceutical and pharmaceutical softgel capsules, exemplifies this trend. Built on Roquette’s market-first Lycagel pea starch technology, this plant-based alternative to gelatin offers manufacturers the flexibility to customize formulations for a range of production and end-user needs. The innovative pea starch foundation also underscores the industry’s move towards sustainable bio-based excipients. The trend towards patient-centric drug development has also influenced excipient innovation. Excipients that can improve palatability, ease of swallowing, or enable novel dosage forms (such as orally disintegrating tablets) are in high demand. For example, IFF brought a super disintegrant Ac-Di-Sol, that supports faster disintegration and drug dissolution in oral disintegrating tablets, improving patient experience.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Our view The heightened regulatory scrutiny on excipients due to product contamination incidents has created a high risk perception and uncertainty around the regulatory acceptance of novel excipients. That said, novel excipients are central to the development of new drug modalities and therapies. Going forward, sustainability will also become an increasingly important factor in excipient selection and development. As the industry innovates towards biologics, personalized therapies, and patient-centric formulations, the role of high-quality, multifunctional excipients will only grow more vital in ensuring drug stability, bioavailability, and patient compliance. Companies that can navigate the complex regulatory landscape, invest in R&D, and offer high-quality, multifunctional excipients will be well-positioned to succeed in this evolving market.   

Impressions: 727

https://www.pharmacompass.com/radio-compass-blog/excipient-market-overview-roquette-seqens-evonik-make-strategic-moves-new-guidelines-deal-with-contamination

#PharmaFlow by PHARMACOMPASS
12 Sep 2024

NEWS #PharmaBuzz

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https://www.pharmabiz.com/NewsDetails.aspx?aid=172507&sid=2

#N/A
18 Sep 2024

https://www.prnewswire.com/news-releases/brooke-shields-partners-with-gsk-to-educate-adults-50-and-older-about-their-shingles-risk-302249282.html

PR NEWSWIRE
16 Sep 2024

https://endpts.com/esmo24-gsk-iteos-rejuvenate-struggling-tigit-space-with-positive-phase-2-jemperli-combo-data-in-lung-cancer/

ENDPNTS
14 Sep 2024

https://www.fiercepharma.com/pharma/gsk-zejula-misses-survival-goal-first-line-ovarian-cancer-pharma-rubraca-opdivo-combo

FIERCE PHARMA
14 Sep 2024

https://www.reuters.com/business/healthcare-pharmaceuticals/gsks-mrna-flu-vaccine-programme-proceed-late-stage-trials-2024-09-12/

REUTERS
13 Sep 2024

https://www.reuters.com/business/healthcare-pharmaceuticals/antifungal-drug-developer-f2g-raises-100-mln-fight-superbugs-fund-late-stage-2024-09-12/

REUTERS
12 Sep 2024

LISTED APIs

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At GSK we have a challenging mission: to improve the quality of human life by enabling people to do more, feel better, live longer. Find out how this shapes everything we do, including our R&D, our partnerships, our work with communities and our efforts to prevent and treat disease around the world. We are a science-led global healthcare company wi...
At GSK we have a challenging mission: to improve the quality of human life by enabling people to do more, feel better, live longer. Find out how this shapes everything we do, including our R&D, our partnerships, our work with communities and our efforts to prevent and treat disease around the world. We are a science-led global healthcare company with a mission: we want to help people to do more, feel better, live longer. The vaccines, medicines and consumer healthcare products that we research and develop can improve people’s health and well-being, ultimately helping them to live life to its fullest and contribute.
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GSK

At GSK we have a challenging mission: to improve the quality of human life by enabling people to do more, feel better, live longer. Find out how this shapes everything we do, including our R&D, our partnerships, our work with communities and our efforts to prevent and treat disease around the world. We are a science-led global healthcare company with a mission: we want to help people to do more, feel better, live longer. The vaccines, medicines and consumer healthcare products that we research and develop can improve people’s health and well-being, ultimately helping them to live life to its fullest and contribute.

About the Company : At GSK we have a challenging mission: to improve the quality of human life by enabling people to do more, feel better, live longer. Find out how this shapes everything we do, including our R&D, ...

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FDF Dossiers

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Brand Name : Fluarix Tetra

Boulder Peptide 2024
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Brand Name : Fluarix Tetra

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Boulder Peptide 2024
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GSK

Dosage Form : INJ

Brand Name : Fluarix Tetra

Dosage Strength : 15ug

Packaging : 0.5X1ug

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Brand Name : Fluarix Tetra

Boulder Peptide 2024
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Brand Name : Fluarix Tetra

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Boulder Peptide 2024
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GSK

Dosage Form : INJ

Brand Name : Fluarix Tetra

Dosage Strength : 15ug

Packaging : 0.5X1ug

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Brand Name : Ziagen

Boulder Peptide 2024
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Brand Name : Ziagen

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ViiV Healthcare

Dosage Form : Drinking Solution

Brand Name : Ziagen

Dosage Strength : 20mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Brand Name : Ziagen

Boulder Peptide 2024
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Brand Name : Ziagen

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ViiV Healthcare

Dosage Form : Tabl

Brand Name : Ziagen

Dosage Strength : 300mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Brand Name : Trizivar

Boulder Peptide 2024
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Brand Name : Trizivar

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GSK

Dosage Form : TAB

Brand Name : Trizivar

Dosage Strength : 300mg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Brand Name : Kivexa

Boulder Peptide 2024
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Brand Name : Kivexa

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GSK

Dosage Form : TAB

Brand Name : Kivexa

Dosage Strength : 600mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Brand Name : Trelavue

Boulder Peptide 2024
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Brand Name : Trelavue

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GSK

Dosage Form : TAB

Brand Name : Trelavue

Dosage Strength : 600mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Brand Name : Ziagen Tablets

Boulder Peptide 2024
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Brand Name : Ziagen Tablets

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GSK

Dosage Form : TAB

Brand Name : Ziagen Tablets

Dosage Strength : 300mg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Brand Name : Ziagen Oral Solution

Boulder Peptide 2024
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Brand Name : Ziagen Oral Solution

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GSK

Dosage Form : SYR

Brand Name : Ziagen Oral Solution

Dosage Strength : 20mg/ml

Packaging : 240X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Brand Name : Ziagen

Boulder Peptide 2024
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Brand Name : Ziagen

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ViiV Healthcare

Dosage Form : Abacavir 20Mg/Ml 240Ml O...

Brand Name : Ziagen

Dosage Strength : os soluz bottle 240 ml...

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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FDA Orange Book

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Brand Name : ZIAGEN

Boulder Peptide 2024
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Brand Name : ZIAGEN

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ViiV Healthcare

Dosage Form : TABLET; ORAL

Proprietary Name : ZIAGEN

Dosage Strength : EQ 300MG BASE

Approval Date : 1998-12-17

Application Number : 20977

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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Brand Name : ZIAGEN

Boulder Peptide 2024
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Brand Name : ZIAGEN

Boulder Peptide 2024
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ViiV Healthcare

Dosage Form : SOLUTION; ORAL

Proprietary Name : ZIAGEN

Dosage Strength : EQ 20MG BASE/ML

Approval Date : 1998-12-17

Application Number : 20978

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AA

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Brand Name : TRIUMEQ

Boulder Peptide 2024
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Brand Name : TRIUMEQ

Boulder Peptide 2024
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ViiV Healthcare

Dosage Form : TABLET; ORAL

Proprietary Name : TRIUMEQ

Dosage Strength : EQ 600MG BASE;EQ 50MG BA...

Approval Date : 2014-08-22

Application Number : 205551

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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Brand Name : TRIUMEQ PD

Boulder Peptide 2024
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Brand Name : TRIUMEQ PD

Boulder Peptide 2024
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ViiV Healthcare

Dosage Form : TABLET, FOR SUSPENSION; ORAL

Proprietary Name : TRIUMEQ PD

Dosage Strength : EQ 60MG BASE;EQ 5MG BASE...

Approval Date : 2022-03-30

Application Number : 215413

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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Brand Name : EPZICOM

Boulder Peptide 2024
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Brand Name : EPZICOM

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ViiV Healthcare

Dosage Form : TABLET; ORAL

Proprietary Name : EPZICOM

Dosage Strength : EQ 600MG BASE;300MG

Approval Date : 2004-08-02

Application Number : 21652

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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Brand Name : TRIZIVIR

Boulder Peptide 2024
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Brand Name : TRIZIVIR

Boulder Peptide 2024
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ViiV Healthcare

Dosage Form : TABLET; ORAL

Proprietary Name : TRIZIVIR

Dosage Strength : EQ 300MG BASE;150MG;300M...

Approval Date : 2000-11-14

Application Number : 21205

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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Brand Name : EXCEDRIN (MIGRAINE R...

Boulder Peptide 2024
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Brand Name : EXCEDRIN (MIGRAINE R...

Boulder Peptide 2024
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Haleon

Dosage Form : TABLET; ORAL

Proprietary Name : EXCEDRIN (MIGRAINE RELIE...

Dosage Strength : 250MG;250MG;65MG

Approval Date : 1998-01-14

Application Number : 20802

RX/OTC/DISCN : OTC

RLD : Yes

TE Code :

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Brand Name : EMPRACET W/ CODEINE ...

Boulder Peptide 2024
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Brand Name : EMPRACET W/ CODEINE ...

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GSK

Dosage Form : TABLET; ORAL

Proprietary Name : EMPRACET W/ CODEINE PHOS...

Dosage Strength : 300MG;30MG

Approval Date : 1982-01-01

Application Number : 83951

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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Brand Name : EMPRACET W/ CODEINE ...

Boulder Peptide 2024
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Brand Name : EMPRACET W/ CODEINE ...

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GSK

Dosage Form : TABLET; ORAL

Proprietary Name : EMPRACET W/ CODEINE PHOS...

Dosage Strength : 300MG;60MG

Approval Date : 1982-01-01

Application Number : 83951

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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Brand Name : ADVIL DUAL ACTION WI...

Boulder Peptide 2024
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Brand Name : ADVIL DUAL ACTION WI...

Boulder Peptide 2024
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Haleon

Dosage Form : TABLET; ORAL

Proprietary Name : ADVIL DUAL ACTION WITH A...

Dosage Strength : 250MG;125MG

Approval Date : 2020-02-28

Application Number : 211733

RX/OTC/DISCN : OTC

RLD : Yes

TE Code :

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Europe

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Brand Name : Ziagen

Boulder Peptide 2024
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Brand Name : Ziagen

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ViiV Healthcare

Dosage Form : Drinking Solution

Dosage Strength : 20mg/ml

Packaging :

Brand Name : Ziagen

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Brand Name : Ziagen

Boulder Peptide 2024
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Brand Name : Ziagen

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ViiV Healthcare

Dosage Form : Tabl

Dosage Strength : 300mg

Packaging :

Brand Name : Ziagen

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Brand Name : Ziagen

Boulder Peptide 2024
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Brand Name : Ziagen

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ViiV Healthcare

Dosage Form : Abacavir 20Mg/Ml 240Ml Oral Us...

Dosage Strength : os soluz bottle 240 ml 20 m...

Packaging :

Brand Name : Ziagen

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Brand Name : Ziagen

Boulder Peptide 2024
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Brand Name : Ziagen

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ViiV Healthcare

Dosage Form : Abacavir 300Mg 60 Units Oral U...

Dosage Strength : 60 cpr riv div 300 mg

Packaging :

Brand Name : Ziagen

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Brand Name : Ziagen

Boulder Peptide 2024
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Brand Name : Ziagen

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ViiV Healthcare

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 300 mg

Packaging : Blister

Brand Name : Ziagen

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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Brand Name : Ziagen

Boulder Peptide 2024
Not Confirmed
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Brand Name : Ziagen

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Boulder Peptide 2024
Not Confirmed

ViiV Healthcare

Dosage Form : ORAL SOLUTION

Dosage Strength : 20 MG / ML

Packaging :

Brand Name : Ziagen

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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07

Brand Name : Ziagen

Boulder Peptide 2024
Not Confirmed
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Brand Name : Ziagen

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Boulder Peptide 2024
Not Confirmed

ViiV Healthcare

Dosage Form : FILM COATED PILL

Dosage Strength : 300 MG

Packaging :

Brand Name : Ziagen

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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08

Brand Name : Trizivir

Boulder Peptide 2024
Not Confirmed
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Brand Name : Trizivir

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Boulder Peptide 2024
Not Confirmed

ViiV Healthcare

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 300 mg/150 mg/300 mg

Packaging : Box

Brand Name : Trizivir

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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Brand Name : Trizivir

Boulder Peptide 2024
Not Confirmed
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Brand Name : Trizivir

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Boulder Peptide 2024
Not Confirmed

ViiV Healthcare

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 300 mg/150 mg/300 mg

Packaging : Blister

Brand Name : Trizivir

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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10

Brand Name : Kivexa

Boulder Peptide 2024
Not Confirmed
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Brand Name : Kivexa

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Boulder Peptide 2024
Not Confirmed

ViiV Healthcare

Dosage Form : Abacavir+Lamivudine 600+300Mg ...

Dosage Strength : 30 cpr riv 600 mg + 300 mg

Packaging :

Brand Name : Kivexa

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Canada

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01

Brand Name : ZIAGEN

Boulder Peptide 2024
Not Confirmed
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Brand Name : ZIAGEN

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Boulder Peptide 2024
Not Confirmed

ViiV Healthcare

Dosage Form : SOLUTION

Dosage Strength : 20MG/ML

Packaging : 240 ML

Brand Name : ZIAGEN

Approval Date :

Application Number : 2240358

Regulatory Info : Prescription

Registration Country : Canada

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02

Brand Name : KIVEXA

Boulder Peptide 2024
Not Confirmed
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Brand Name : KIVEXA

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Boulder Peptide 2024
Not Confirmed

ViiV Healthcare

Dosage Form : TABLET

Dosage Strength : 600MG

Packaging : 30

Brand Name : KIVEXA

Approval Date :

Application Number : 2269341

Regulatory Info : Prescription

Registration Country : Canada

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03

Brand Name : TRIUMEQ

Boulder Peptide 2024
Not Confirmed
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Brand Name : TRIUMEQ

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Boulder Peptide 2024
Not Confirmed

ViiV Healthcare

Dosage Form : TABLET

Dosage Strength : 600MG

Packaging : 30

Brand Name : TRIUMEQ

Approval Date :

Application Number : 2430932

Regulatory Info : Prescription

Registration Country : Canada

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04

Brand Name : NEOCITRAN ULTRA STRE...

Boulder Peptide 2024
Not Confirmed
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Brand Name : NEOCITRAN ULTRA STRE...

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Boulder Peptide 2024
Not Confirmed

Haleon

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 1000MG/SACHET

Packaging : 10

Brand Name : NEOCITRAN ULTRA STRENGTH TOTA...

Approval Date :

Application Number : 2217147

Regulatory Info : OTC

Registration Country : Canada

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05

Brand Name : ROBAXACET-8

Boulder Peptide 2024
Not Confirmed
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Brand Name : ROBAXACET-8

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Boulder Peptide 2024
Not Confirmed

GSK

Dosage Form : TABLET

Dosage Strength : 325MG

Packaging :

Brand Name : ROBAXACET-8

Approval Date :

Application Number : 1934767

Regulatory Info : Narcotic (CDSA I)

Registration Country : Canada

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06

Brand Name : BUCKLEY'S COLD & SIN...

Boulder Peptide 2024
Not Confirmed
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Brand Name : BUCKLEY'S COLD & SIN...

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Boulder Peptide 2024
Not Confirmed

Haleon

Dosage Form : KIT

Dosage Strength : 325MG

Packaging :

Brand Name : BUCKLEY'S COLD & SINUS 24 HOU...

Approval Date :

Application Number : 2493802

Regulatory Info : OTC

Registration Country : Canada

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07

Brand Name : BUCKLEY'S COMPLETE N...

Boulder Peptide 2024
Not Confirmed
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Brand Name : BUCKLEY'S COMPLETE N...

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Boulder Peptide 2024
Not Confirmed

Haleon

Dosage Form : CAPSULE

Dosage Strength : 325MG

Packaging :

Brand Name : BUCKLEY'S COMPLETE NIGHTTIME ...

Approval Date :

Application Number : 2335239

Regulatory Info : OTC

Registration Country : Canada

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08

Brand Name : BUCKLEY'S COMPLETE +...

Boulder Peptide 2024
Not Confirmed
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Brand Name : BUCKLEY'S COMPLETE +...

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Boulder Peptide 2024
Not Confirmed

Haleon

Dosage Form : CAPSULE

Dosage Strength : 250MG

Packaging :

Brand Name : BUCKLEY'S COMPLETE + MUCUS RE...

Approval Date :

Application Number : 2335948

Regulatory Info : OTC

Registration Country : Canada

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09

Brand Name : NEOCITRAN EXTRA STRE...

Boulder Peptide 2024
Not Confirmed
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Brand Name : NEOCITRAN EXTRA STRE...

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Boulder Peptide 2024
Not Confirmed

Haleon

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 650MG/SACHET

Packaging : 10

Brand Name : NEOCITRAN EXTRA STRENGTH COLD...

Approval Date :

Application Number : 2456982

Regulatory Info : OTC

Registration Country : Canada

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10

Brand Name : NEOCITRAN ULTRA STRE...

Boulder Peptide 2024
Not Confirmed
arrow

Brand Name : NEOCITRAN ULTRA STRE...

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Boulder Peptide 2024
Not Confirmed

Haleon

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 1000MG/SACHET

Packaging : 10 PCK

Brand Name : NEOCITRAN ULTRA STRENGTH TOTA...

Approval Date :

Application Number : 2404966

Regulatory Info : OTC

Registration Country : Canada

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South Africa

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01

Brand Name : Fluarix Tetra

Boulder Peptide 2024
Not Confirmed
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Brand Name : Fluarix Tetra

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Boulder Peptide 2024
Not Confirmed

GSK

Dosage Form : INJ

Dosage Strength : 15ug

Packaging : 0.5X1ug

Brand Name : Fluarix Tetra

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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02

Brand Name : Fluarix Tetra

Boulder Peptide 2024
Not Confirmed
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Brand Name : Fluarix Tetra

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Boulder Peptide 2024
Not Confirmed

GSK

Dosage Form : INJ

Dosage Strength : 15ug

Packaging : 0.5X1ug

Brand Name : Fluarix Tetra

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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03

Brand Name : Trizivar

Boulder Peptide 2024
Not Confirmed
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Brand Name : Trizivar

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Boulder Peptide 2024
Not Confirmed

GSK

Dosage Form : TAB

Dosage Strength : 300mg

Packaging : 60X1mg

Brand Name : Trizivar

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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04

Brand Name : Kivexa

Boulder Peptide 2024
Not Confirmed
arrow

Brand Name : Kivexa

arrow
Boulder Peptide 2024
Not Confirmed

GSK

Dosage Form : TAB

Dosage Strength : 600mg

Packaging : 30X1mg

Brand Name : Kivexa

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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05

Brand Name : Trelavue

Boulder Peptide 2024
Not Confirmed
arrow

Brand Name : Trelavue

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Boulder Peptide 2024
Not Confirmed

GSK

Dosage Form : TAB

Dosage Strength : 600mg

Packaging : 30X1mg

Brand Name : Trelavue

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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06

Brand Name : Ziagen Tablets

Boulder Peptide 2024
Not Confirmed
arrow

Brand Name : Ziagen Tablets

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Boulder Peptide 2024
Not Confirmed

GSK

Dosage Form : TAB

Dosage Strength : 300mg

Packaging : 60X1mg

Brand Name : Ziagen Tablets

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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07

Brand Name : Ziagen Oral Solution

Boulder Peptide 2024
Not Confirmed
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Brand Name : Ziagen Oral Solution

arrow
Boulder Peptide 2024
Not Confirmed

GSK

Dosage Form : SYR

Dosage Strength : 20mg/ml

Packaging : 240X1mg/ml

Brand Name : Ziagen Oral Solution

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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08

Brand Name : Zovirax

Boulder Peptide 2024
Not Confirmed
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Brand Name : Zovirax

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Boulder Peptide 2024
Not Confirmed

GSK

Dosage Form : OIN

Dosage Strength : 30mg/g

Packaging : 4.5X1mg/g

Brand Name : Zovirax

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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09

Brand Name : Zovirax IV

Boulder Peptide 2024
Not Confirmed
arrow

Brand Name : Zovirax IV

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Boulder Peptide 2024
Not Confirmed

GSK

Dosage Form : INJ

Dosage Strength : 250mg

Packaging : 10X5mg

Brand Name : Zovirax IV

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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10

Brand Name : Zovirax Suspension

Boulder Peptide 2024
Not Confirmed
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Brand Name : Zovirax Suspension

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Boulder Peptide 2024
Not Confirmed

GSK

Dosage Form : SUS

Dosage Strength : 200mg/5ml

Packaging : 125X1mg/5ml

Brand Name : Zovirax Suspension

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Excipients

Click here to find the perfect excipient manufacturers by their capabilities

All Excipients

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01

EMPTY HARD GELATIN CAPSULES

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

Boulder Peptide 2024
Not Confirmed
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EMPTY HARD GELATIN CAPSULES

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

arrow
Boulder Peptide 2024
Not Confirmed
USDMF Inactive-api CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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USDMF

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01

EMPTY HARD GELATIN CAPSULES

Boulder Peptide 2024
Not Confirmed
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EMPTY HARD GELATIN CAPSULES

arrow
Boulder Peptide 2024
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 5770

Submission : 1985-04-08

Status : Inactive

Type : IV

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Inspections and registrations

Upload your audits for free, ask us

EDQM

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01

GMP Certified

EU
Boulder Peptide 2024
Not Confirmed
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GMP Certified

EU
arrow
Boulder Peptide 2024
Not Confirmed

GSK

Type : GMP Certificates

Number : BE/GMP/2016...

EudraGMDP Key : 8728

Country : U.S.A

Issue Date : 2016-03-10

Post Code : PA 17547

NCA Ref : 872812683896...

City : Marietta

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02

GMP Certified

EU
Boulder Peptide 2024
Not Confirmed
arrow

GMP Certified

EU
arrow
Boulder Peptide 2024
Not Confirmed

GSK

Type : GMP Certificates

Number : 15MPP079HPT...

EudraGMDP Key : 39620

Country : Singapore

Issue Date : 2016-02-24

Post Code : 618809

NCA Ref : 396201456308...

City : Singapore

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03

GMP Certified

EU
Boulder Peptide 2024
Not Confirmed
arrow

GMP Certified

EU
arrow
Boulder Peptide 2024
Not Confirmed

GSK

Type : GMP Certificates

Number : HPF/FR/50/2...

EudraGMDP Key : 39262

Country : France

Issue Date : 2016-02-24

Post Code : 27000

NCA Ref : 410352777000...

City : EVREUX

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04

GMP Certified

EU
Boulder Peptide 2024
Not Confirmed
arrow

GMP Certified

EU
arrow
Boulder Peptide 2024
Not Confirmed

GSK

Type : GMP Certificates

Number : HPF/FR/49/2...

EudraGMDP Key : 39262

Country : France

Issue Date : 2016-02-24

Post Code : 27000

NCA Ref : 410352777000...

City : EVREUX

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05

GMP Certified

EU
Boulder Peptide 2024
Not Confirmed
arrow

GMP Certified

EU
arrow
Boulder Peptide 2024
Not Confirmed

GSK

Type : GMP Certificates

Number : BE/2013/035

EudraGMDP Key : 8728

Country : U.S.A

Issue Date : 2015-12-21

Post Code : PA 17547

NCA Ref : 872812683896...

City : Marietta

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06

GMP Certified

EU
Boulder Peptide 2024
Not Confirmed
arrow

GMP Certified

EU
arrow
Boulder Peptide 2024
Not Confirmed

GSK

Type : GMP Certificates

Number : DE_SH_01_GM...

EudraGMDP Key : 36597

Country : South Africa

Issue Date : 2015-11-05

Post Code : 7460

NCA Ref : 00023039

City : Cape Town

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07

GMP Certified

EU
Boulder Peptide 2024
Not Confirmed
arrow

GMP Certified

EU
arrow
Boulder Peptide 2024
Not Confirmed

GSK

Type : GMP Certificates

Number : UK MIA(IMP)...

EudraGMDP Key : 6674

Country : United Kingdom

Issue Date : 2015-11-03

Post Code : DL12 8DT

NCA Ref : 3848-GLAXO O...

City : BARNARD CASTLE

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08

GMP Certified

EU
Boulder Peptide 2024
Not Confirmed
arrow

GMP Certified

EU
arrow
Boulder Peptide 2024
Not Confirmed

GSK

Type : GMP Certificates

Number : UK MIA 4 In...

EudraGMDP Key : 6674

Country : United Kingdom

Issue Date : 2015-11-03

Post Code : DL12 8DT

NCA Ref : 3848-GLAXO O...

City : BARNARD CASTLE

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09

GMP Certified

EU
Boulder Peptide 2024
Not Confirmed
arrow

GMP Certified

EU
arrow
Boulder Peptide 2024
Not Confirmed

GSK

Type : GMP Certificates

Number : UK ManA 4 I...

EudraGMDP Key : 6674

Country : United Kingdom

Issue Date : 2015-11-03

Post Code : DL12 8DT

NCA Ref : 3848-GLAXO O...

City : BARNARD CASTLE

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10

GMP Certified

EU
Boulder Peptide 2024
Not Confirmed
arrow

GMP Certified

EU
arrow
Boulder Peptide 2024
Not Confirmed

GSK

Type : GMP Non-Compliance

Number : Insp GMP 28...

EudraGMDP Key : 11629

Country : China

Issue Date : 2015-10-23

Post Code : CN-300457

NCA Ref : 122298- GLAX...

City : TIANJIN

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WHO-GMP

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01

WHO GMP Certified

Switzerland
Boulder Peptide 2024
Not Confirmed
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WHO GMP Certified

Switzerland
arrow
Boulder Peptide 2024
Not Confirmed

GSK

Name and address of WHO GMP certified Manufacturer : GLAXOSMITHKLINE ASIA PRIVATE LIMITED A 10/1, ADDITIONAL M.I.D.C. AREA, AMBAD PATHARDI BLOCK NASHIK 422010

Country : United Kingdom

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02

WHO GMP Certified

Switzerland
Boulder Peptide 2024
Not Confirmed
arrow

WHO GMP Certified

Switzerland
arrow
Boulder Peptide 2024
Not Confirmed

GSK

Name and address of WHO GMP certified Manufacturer : GLAXOSMITHKLINE PHARMACEUTICALS LTD. A-10 ADDITIONAL M.I.D.C. INDUSTIRAL AREA, AMBAD-PATHARDI BLOCK NASHIK NASHIK 422010

Country : United Kingdom

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GDUFA

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01

GDUFA fees paid

USA
Boulder Peptide 2024
Not Confirmed
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GDUFA fees paid

USA
arrow
Boulder Peptide 2024
Not Confirmed

API Manufacturer : API MANUFACTURE

FDF Manufacturer :

Facility Name : Beecham Pharmaceuticals (Pte) ...

Business Address : 38 Quality Road Jurong 61880...

FEI Number : 3003469490

Country : United Kingdom

Paid in : 2019

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02

GDUFA fees paid

USA
Boulder Peptide 2024
Not Confirmed
arrow

GDUFA fees paid

USA
arrow
Boulder Peptide 2024
Not Confirmed

API Manufacturer :

FDF Manufacturer : FDF MANUFACTURE

Facility Name : GlaxoSmithKline Manufacturing ...

Business Address : Via Alessandro Fleming 2 Ver...

FEI Number : 3002807084

Country : United Kingdom

Paid in : 2019

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03

GDUFA fees paid

USA
Boulder Peptide 2024
Not Confirmed
arrow

GDUFA fees paid

USA
arrow
Boulder Peptide 2024
Not Confirmed

API Manufacturer : API MANUFACTURE

FDF Manufacturer :

Facility Name : SmithKline Beecham LTD

Business Address : Shewalton Road Irvine Aryshi...

FEI Number : 3003723174

Country : United Kingdom

Paid in : 2019

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ABOUT THIS PAGE

Contact GSK and get a quotation

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