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    Drug Approvals by the Medicines Control Council in South Africa of Merck & Co. Inc. Original Data : South African Medicines Price Registry

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

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    Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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    Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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    Our goal is to lead the way to a healthier future. But we also care about how we get there together. As a company whose products touch the lives and well being of people around the world, we hold ourselves to a high standard. And we expect others to hold us to that same high standard. We believe in operating openly, honestly and with the highest degree of ethics and integrity. This includes: making sure that the compa...
    Our goal is to lead the way to a healthier future. But we also care about how we get there together. As a company whose products touch the lives and well being of people around the world, we hold ourselves to a high standard. And we expect others to hold us to that same high standard. We believe in operating openly, honestly and with the highest degree of ethics and integrity. This includes: making sure that the company complies with all applicable laws and regulations globally.

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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “We’re unlocking life-changing potential in complex molecules, without sacrificing time to market”

    “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

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    #SpeakPharma With Veranova
    10 Sep 2024
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    DATA COMPILATION #PharmaFlow

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    2024 US Elections: Harris, Trump differ on abortion rights, ACA, public health spends; agree on need to cut drug prices

    2024 US Elections: Harris, Trump differ on abortion rights, ACA, public health spends; agree on need to cut drug prices

    The US is in the midst of yet another, or perhaps the most, polarizing Presidential election. The two candidates have highly divergent personas, records, visions and views. That gets reflected in their starkly different visions for the healthcare system.Healthcare is the second most important issue for voters in the 2024 US elections, with only the economy ranking higher, according to the Pew Research Center.In this week’s PharmaFlow, we look at the past approaches of both the contenders — Democratic presidential nominee Kamala Harris and Republican contender Donald Trump — towards healthcare, and what the two presidencies could mean for the US healthcare industry.Both Harris and Trump have a rare point of agreement — that the US government should act on reducing high drug prices. But have they spelt out how they will make healthcare more accessible? Our analysis should give you some answers.Abortion remains a pivotal issue, may shape broader discussions on healthcareTrump takes pride in the fact that he played an important role in overturning Roe v. Wade, a ruling that protected the abortion rights of women across America. Trump did that by selecting Supreme Court justices who were instrumental in overturning it. Two and a half years after Roe v. Wade was overturned, Trump faces an electorate that largely seems to favor abortion rights — according to Pew Research, 63 percent respondents say abortion should be legal in all or most cases, while 36 percent say it should be illegal in all or most cases.Candidates’ stances on abortion access, including the regulation on medications like mifepristone, are being scrutinized by both supporters and opponents of abortion rights. In June this year, the US Supreme Court had unanimously rejected a case to restrict access to the abortion drug mifepristone. The demand for its ban had been raised by an anti-abortion group in Texas.Of late, there have been reports of Republicans trying to distance themselves from aggressive anti-abortion ideas coming from its party men and allies. Aiming to carve-out a political middle ground, Trump has said that abortion policy should be made by the states. Despite Trump’s softening of stance, abortion rights is likely to not only affect voter turnout, but also shape broader discussions on healthcare and women’s rights.Affordable Care Act: Harris to strengthen it, Trump has ‘concepts of a plan’ to replace itHarris has been all for expanding and strengthening the Affordable Care Act (ACA). She has promised to “make affordable healthcare a right, not a privilege.”Trump, on the other hand, had made attempts during his presidency to repeal and replace the ACA, arguing that it provided “lousy healthcare.” While those efforts ultimately failed in the Senate, Trump succeeded in weakening the ACA by eliminating the individual mandate penalty through the 2017 Tax Cuts and Jobs Act.In a potential second term, Trump might renew efforts to dismantle or significantly alter the ACA. Although he has not presented a comprehensive replacement plan, he said during the Presidential debate held on September 9 that he has “concepts of a plan.”Drug prices: Harris to accelerate Medicare price cuts; Trump to focus on genericsHarris has had an aggressive stance on reducing prescription drug costs. Her tie-breaking vote on the Inflation Reduction Act gave Medicare the power to negotiate lower drug prices with pharmaceutical companies.Harris has pledged to accelerate those negotiations, once she becomes President, to cover more drugs and further lower prices for Americans. She also intends to extend the US$ 35 cap on insulin and the US$ 2,000 cap on out-of-pocket spending for seniors to all Americans, not just those on Medicare.Harris plans to make permanent the Biden-Harris tax credit enhancements that have already lowered healthcare premiums by an average of about US$ 800 a year for millions of Americans. This move would ensure continued accessibility to health insurance for a broader segment of the population.However, her stance on insurance companies and Big Pharma, including her support for “march-in” rights, might face resistance from pharmaceutical companies concerned about maintaining incentives for innovation.On the issue of drug pricing, Trump’s record is mixed. While he took credit for some decreases in prescription drug prices during his presidency, his administration’s most significant regulatory changes often favored pharmaceutical companies.Trump did issue a rule setting up a path to import drugs from Canada and other countries, but this initiative has faced significant hurdles, including pushback from Canadian authorities.Trump’s stance on drug pricing for a potential second term appears to focus on increasing generic and biosimilar competition, importing drugs made in the US but sold overseas back to the US, and capping out-of-pocket insulin costs. While he has criticized Big Pharma for putting profits above people, his administration’s policies had often aligned with industry interests.Harris appears committed to drug control; Trump had cut public health fundsMental health and substance abuse are the other areas where Harris has shown strong commitment. Having prosecuted drug traffickers, she has demonstrated her commitment to curbing the opioid epidemic.In the White House, she helped direct more than US$ 150 billion to disrupt the flow of illicit drugs and delivered billions of dollars in investments to states to fund lifesaving programs. Under a Harris administration, we might see increased funding for addiction treatment programs and continued efforts to make overdose-reversal drugs like naloxone more accessible.During his presidency, Trump had significantly reduced funding for public health programs. His administration had suggested budget cuts to the Centers for Disease Control and Prevention (CDC) and other public health agencies, justifying them as measures for fiscal responsibility.Our viewGiven her record, a Harris presidency could lead to increased insurance coverage. However, it might also come with increased regulation and price controls. More aggressive drug price negotiations could pressure pharmaceutical companies’ profit margins, potentially affecting R&D budgets. Stricter vigilance on the pharmaceutical industry could lead to more litigation and regulatory challenges for drug companies. But in the long run, this might also improve public trust in drug companies and in the healthcare systems.Under a second Trump term, reduced public health funding could create challenges for community health providers and public health initiatives. An emphasis on generic competition could pressure brand-name drug manufacturers, but create opportunities for generic drug makers.
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    https://www.pharmacompass.com/radio-compass-blog/2024-us-elections-harris-trump-differ-on-abortion-rights-aca-public-health-spends-agree-on-need-to-cut-drug-prices

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    26 Sep 2024
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    Merck’s Keytruda Combo Fails in Phase III Colorectal Cancer Study
    Merck’s Keytruda Combo Fails in Phase III Colorectal Cancer Study

    26 Sep 2024

    // PRESS RELEASE

    https://www.merck.com/news/merck-provides-update-on-phase-3-keyform-007-trial-evaluating-investigational-fixed-dose-combination-of-favezelimab-and-pembrolizumab-for-patients-with-previously-treated-pd-l1-positive-microsatellite/

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    26 Sep 2024
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    FDA challenges broad use of PD-1 drugs in stomach cancer
    FDA challenges broad use of PD-1 drugs in stomach cancer

    24 Sep 2024

    // FIERCE PHARMA

    https://www.fiercepharma.com/pharma/ahead-adcomm-fda-challenges-pd-1-drug-classs-broad-use-stomach-cancer-patients

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    24 Sep 2024
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    Merck Receives Positive EU CHMP Opinions for KEYTRUDA
    Merck Receives Positive EU CHMP Opinions for KEYTRUDA

    20 Sep 2024

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    https://www.businesswire.com/news/home/20240919651678/en

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    20 Sep 2024
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    Merck, Daiichi's ADC Lung Cancer Trial Shows Promise Despite Deaths
    Merck, Daiichi's ADC Lung Cancer Trial Shows Promise Despite Deaths

    18 Sep 2024

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20240917471670/en/Patritumab-Deruxtecan-Demonstrated-Statistically-Significant-Improvement-in-Progression-Free-Survival-Versus-Doublet-Chemotherapy-in-Patients-with-Locally-Advanced-or-Metastatic-EGFR-Mutated-Non-Small-Cell-Lung-Cancer-in-HERTHENA-Lung02-Phase-3-Trial

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    18 Sep 2024
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    Amgen And Merck Join Academic Clinical Trial Diversity Initiative
    Amgen And Merck Join Academic Clinical Trial Diversity Initiative

    16 Sep 2024

    // FIERCE BIOTECH

    https://www.fiercebiotech.com/cro/amgen-and-merck-become-first-industry-partners-academic-clinical-trial-diversity-initiative

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    16 Sep 2024
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    Merck's KEYTRUDA Demonstrates 10-Year Survival Benefit In Melanoma
    Merck's KEYTRUDA Demonstrates 10-Year Survival Benefit In Melanoma

    15 Sep 2024

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20240915454590/en

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    15 Sep 2024
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    PRODUCT 8198 TABLETING AID T

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    Merck & Co

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 11859

    Submission : 1996-02-16

    Status : Inactive

    Type : IV

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    PRODUCT 8198 TABLETING AID T

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    Merck & Co

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 3796

    Submission : 1980-05-01

    Status : Inactive

    Type : IV

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    TITANIUM DIOXIDE

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    Merck & Co

    NDC Package Code : 14639-8020

    Start Marketing Date : 2019-05-16

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (0.8kg/kg)

    Marketing Category : DRUG FOR FURTHER PRO...

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    TITANIUM DIOXIDE

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    Merck & Co

    NDC Package Code : 14639-8030

    Start Marketing Date : 2019-05-16

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (0.785kg/kg)

    Marketing Category : DRUG FOR FURTHER PRO...

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    TITANIUM DIOXIDE

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    Merck & Co

    NDC Package Code : 14639-8040

    Start Marketing Date : 2019-05-16

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (0.78kg/kg)

    Marketing Category : DRUG FOR FURTHER PRO...

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    TITANIUM DIOXIDE

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    Merck & Co

    NDC Package Code : 14639-8000

    Start Marketing Date : 2018-12-18

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (0.8kg/kg)

    Marketing Category : DRUG FOR FURTHER PRO...

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    Merck & Co

    NDC Package Code : 14639-8432

    Start Marketing Date : 2016-06-15

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (5kg/5kg)

    Marketing Category : BULK INGREDIENT

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    Merck & Co

    NDC Package Code : 14639-8432

    Start Marketing Date : 2014-07-19

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

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    UREA

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    Merck & Co

    NDC Package Code : 14639-8432

    Start Marketing Date : 2016-02-22

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    UREA

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    Merck & Co

    NDC Package Code : 14639-8432

    Start Marketing Date : 2016-06-15

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    GMP Certified

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    Merck & Co

    Type : GMP Certificates

    Number : UK GMP 1373...

    EudraGMDP Key : 7740

    Country : U.S.A

    Issue Date :

    Post Code : VA 22827

    NCA Ref : 4246-MERCK &...

    City : ELKTON

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    Merck & Co

    Type : GMP Certificates

    Number : NL/H 09/002...

    EudraGMDP Key : 7740

    Country : U.S.A

    Issue Date :

    Post Code : VA 22827

    NCA Ref : 4246-MERCK &...

    City : ELKTON

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    Type : GMP Certificates

    Number : NL/H 09/002...

    EudraGMDP Key : 8855

    Country : U.S.A

    Issue Date :

    Post Code : 19486-0004

    NCA Ref : 4339-MERCK A...

    City : WEST POINT

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    Merck & Co

    Type : GMP Certificates

    Number : NL/H 10/007...

    EudraGMDP Key : 8855

    Country : U.S.A

    Issue Date :

    Post Code : 19486-0004

    NCA Ref : 4339-MERCK A...

    City : WEST POINT

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    GMP Certified

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    Merck & Co

    Type : GMP Certificates

    Number : NL/H 10/007...

    EudraGMDP Key : 8855

    Country : U.S.A

    Issue Date :

    Post Code : 19486-0004

    NCA Ref : 4339-MERCK A...

    City : WEST POINT

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    GMP Certified

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    Merck & Co

    Type : GMP Certificates

    Number : NL/H 10/007...

    EudraGMDP Key : 8855

    Country : U.S.A

    Issue Date :

    Post Code : 19486-0004

    NCA Ref : 4339-MERCK A...

    City : WEST POINT

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    GMP Certified

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    Merck & Co

    Type : GMP Certificates

    Number : NL/H 11/007...

    EudraGMDP Key : 10967

    Country : U.S.A

    Issue Date :

    Post Code : 19486

    NCA Ref : PIF/9267

    City : West Point, PA

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    Merck & Co

    Type : GMP Certificates

    Number : HMP/PT/23/2...

    EudraGMDP Key : 11992

    Country : Singapore

    Issue Date :

    Post Code : 638408

    NCA Ref : A015 9625 37...

    City : SINGAPORE

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    Merck & Co

    Type : GMP Certificates

    Number : NL/H 13/011...

    EudraGMDP Key : 20275

    Country : U.S.A

    Issue Date :

    Post Code : NC 27712

    NCA Ref : 2.0275138306...

    City : Durham

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    Merck & Co

    Type : GMP Certificates

    Number : NL/H 14/100...

    EudraGMDP Key : 10967

    Country : U.S.A

    Issue Date :

    Post Code : 19486

    NCA Ref : PIF/9267

    City : West Point, PA

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