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    Drug Approvals by the Medicines Control Council in South Africa of Hetero Drugs. Original Data : South African Medicines Price Registry

    EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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    Bora Pharmaceuticals- Making success more certain.

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    Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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    Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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    Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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    About

    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertica...
    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.

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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    "ICE is pioneering sustainability, innovation in bile acid research for neurodegenerative diseases”

    "ICE is pioneering sustainability, innovation in bile acid research for neurodegenerative diseases”

    This week, SpeakPharma interviews Roger Viney, Chief Commercial Officer of ICE Pharma, a world-leading manufacturer of specialty biliary acid products with a focus on innovation, environmental responsibility, and a strong company culture. Viney discusses the company’s ambitious sustainability targets, and its exciting research into bile acids’ potential in treating neurodegenerative diseases like Parkinson’s.  🔑 HIGHLIGHTS// focus on innovation, environmental responsibility, and a strong company culture ICE Pharma has set four strategic pillars to guide its sustainability efforts. Can you tell us what these four pillars are and how they contribute to the long-term resilience of the business and its supply chain? In 2022, we developed a comprehensive long-term sustainability strategy, accompanied by a short-term roadmap to guide our actions over the next three years. This outlines the strategic choices that will define our way forward and details the progress we are making against our roadmap. Our sustainability strategy is designed to bolster the long-term resilience of our business and supply chain, provide a source of fulfillment for our employees and enable our customers to continue developing and delivering treatments for hepatic and neurological diseases, as well as other conditions that respond to bile acid-based therapies. By contributing holistically to a healthier society and environment, our strategy aims to create long-term value. We aim to maximize our positive impact on health by opening our Biliary Acid Library of potential new molecules to further the development of these treatments. Additionally, we strive to reduce our environmental footprint by creating products with fewer raw materials, diversifying the animal sources we use, and exploring new plant-based bile acid derivatives. We have established clear targets along four strategic pillars, supported by robust ESG governance and leadership. Firstly, we are committed to fighting illness through product innovation. By providing innovative, safe, and high-quality pharmaceutical ingredients, we help our customers build a healthier society. Secondly, we focus on accelerating sustainable operations by monitoring and reducing our emissions, energy, and water consumption through robust ESG processes and accountability. Thirdly, we prioritize building strong relationships by managing our supply chain transparently, fostering strong supplier relationships, and adhering to responsible business practices. Lastly, we are dedicated to caring for people by cultivating a transformational and inclusive culture that ensures the well-being and development of our employees. 🔑 HIGHLIGHTS// Biliary Acid Library of potential new molecules / robust ESG governance and leadership / manage our supply chain transparently ICE Pharma has committed to an ambitious sustainability plan. Can you elaborate on specific targets it has set to reduce greenhouse gas (GHG) emissions and increase the use of renewable energy? Also, what significant investments have ICE made or plans to make to support these goals? ICE’s carbon footprint aligns with industry standards in the pharmaceutical and API sectors in terms of GHG emissions. We have set an internal target that is challenging yet achievable and aligned with our business objectives – a 20 percent reduction in Scope 1 and 2 emissions (majorly energy-related) and a 30 percent reduction in Scope 3 emissions (from solvents, reagents, and animal byproducts used as raw materials) by 2033. We plan to achieve these targets through two main approaches. For electric power, we aim to achieve 100 percent renewable energy utilization by 2030, and we are well on track to achieve this. We are heavily investing in renewable sources, either through sourcing green energy or through in-house investments in photovoltaic (PV) systems at our factories. Fortunately, the significant growth in installed renewable capacity across all geographies where we operate makes this goal both achievable and financially sustainable. However, a substantial portion of our energy consumption comes from generating heat involved in our processes. To counter this, we are focusing on energy efficiency, targeting over 90 percent of our energy consumption to be covered by ISO 50001 standards, and investing heavily in more efficient technologies. For Scope 3 emissions, our efforts are concentrated on further developing our processes to reduce the amount of chemicals used, improve our yields, and switch to animal-source raw materials with a smaller carbon footprint. 🔑 HIGHLIGHTS// internal target that is challenging yet achievable / 100 percent renewable energy utilization by 2030 ICE Pharma highlights its strong company culture as one of the secrets to its success. Can you speak on how you foster a collaborative and respectful work environment, and how these efforts contribute to the company’s overall success? At ICE Pharma, we place great emphasis on building a collaborative and respectful work environment, recognizing it as a key driver of innovation and success. Our culture is fostered by our Cultural Pillars: Unity, Evolution, and Achievement. These pillars shape our approach in several key areas. Firstly, we value diversity and inclusion. Operating across different cultural contexts and geographies, we have gathered a diverse range of ethnicities. We actively ensure that all voices are represented. This promotes a culture where everyone is respected for their unique perspectives. Secondly, recognizing employee contributions is fundamental to our approach. ICE Pharma celebrates achievements and milestones, ensuring that employees feel valued. We also support professional development and personal growth of employees through initiatives such as secondments and international mentoring programs, and financial support for excellence training courses. This creates motivation and loyalty, reinforcing a positive company atmosphere. Thirdly, we understand the importance of work-life balance. We promote policies that allow employees to maintain a healthy equilibrium between their professional and personal lives, with a special focus on parenthood. This respect for individual well-being translates into a happier, more engaged workforce. By fostering these values, we create a work environment that drives productivity, encourages innovation, and strengthens the company’s overall success. 🔑 HIGHLIGHTS// value diversity and inclusion / recognize employee contributions / understand the importance of work-life balance Considering the unique properties of bile acids, can you discuss how ICE Pharma is leveraging its technology to develop innovative drug delivery systems for emerging therapies or to address challenges with existing medications? We are thrilled about the expanding role of bile acids in medicine. ICE Pharma holds a unique position, being deeply involved in fundamental research, developing new bile acids, bringing them into clinical trials, and manufacturing generic medicines based on these compounds. Recent research has highlighted the role of bile acids as metabolic regulators, revealing their potential to treat a variety of diseases. They have emerged as an excellent class of molecules for targeting metabolic conditions such as type 2 diabetes, obesity, and non-alcoholic fatty liver disease (NAFLD). Bile acids are now known to act on several nuclear receptors, and it is becoming clear that their signaling properties are complex and extend beyond the FXR and TGR5 receptors, where most current research is focused. One particularly exciting area of interest is the potential of bile acids in treating neurodegenerative diseases. In collaboration with the Ferrier Institute, we have contributed to research on Parkinson’s disease. Mitochondrial dysfunction is a well-documented mechanism in both sporadic and familial Parkinson’s disease. Ursodeoxycholic acid (UDCA) has been identified as a bile acid that enhances mitochondrial function in multiple in vitro and in vivo models of Parkinson’s disease. Our studies indicate that modified novel bile acid molecules could lead to the development of more efficacious treatments that improve mitochondrial function and overall cellular health, presenting promising new therapeutic options for Parkinson’s disease. 🔑 HIGHLIGHTS// potential of bile acids in treating neurodegenerative diseases / contributed to research on Parkinson’s disease / present promising new therapeutic options Given ICE Pharma’s commitment to the highest quality and regulatory compliance standards, can you elaborate on how the company ensures that these standards are consistently maintained, especially when dealing with the complexities of animal-derived products? At ICE, we place great emphasis on controlling pathogens in our animal-derived products, ensuring safety and quality throughout the entire supply chain, from the collection of bile to the finished product. The bile is sourced exclusively from authorized countries, and each production batch is meticulously traced to certify that every animal has been raised and sacrificed according to specific guidelines. The initial step in bile processing involves a treatment that certifies the product as TSE/BSE Free. This is followed by at least two additional stages, based on experimental studies conducted by specialized laboratories, which are effective in inactivating viruses. Intermediates and the final product are handled in closed cycles or in contamination-controlled areas (ISO-8 cleanrooms). Beyond these fundamental aspects, ICE is deeply committed to keeping its dossiers up to date with the latest guidelines and constantly monitoring trends in analytical data to ensure consistent product quality. Where possible, we enhance this quality through a change control plan carefully managed by our Quality Assurance team. Staff training, predictive and preventive maintenance plans, equipment qualification, and process validation are crucial activities involving the entire workforce with the support of the Quality Unit. Our commitment to continuous improvement drives us to focus on digital globalization to ensure ever-greater transparency and reliability in the data that supports our work. As John Ruskin said, “quality is never an accident. It is always the result of intelligent effort.” We continue to follow this philosophy in our daily commitment. 🔑 HIGHLIGHTS// bile is sourced exclusively from authorized countries / each production batch is meticulously traced / ensure ever-greater transparency and reliability

    Impressions: 84

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    https://www.pharmacompass.com/speak-pharma/ice-is-pioneering-sustainability-innovation-in-bile-acid-research-for-neurodegenerative-diseases

    #SpeakPharma With ICE Pharma
    30 Sep 2024
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    VLOG #PharmaReel

    [Sponsored by another company]

    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    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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    Impressions: 700

    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

    #Phispers by PHARMACOMPASS
    26 Sep 2024
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    NEWS #PharmaBuzz

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    Hetero's Generic Pemetrexed Disodium Receives Approval in the U.S.
    Hetero's Generic Pemetrexed Disodium Receives Approval in the U.S.

    14 Jun 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215460

    FDA
    14 Jun 2024
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    Hetero Labs Generic Ertugliflozin Receives Tentative Approval in US
    Hetero Labs Generic Ertugliflozin Receives Tentative Approval in US

    17 Apr 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217071

    FDA
    17 Apr 2024
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    Hetero's Generic Eszopiclone Receives Approval in the U.S.
    Hetero's Generic Eszopiclone Receives Approval in the U.S.

    04 Jan 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205504

    FDA
    04 Jan 2024
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    Enforcement Report - Week of May 17, 2023
    Enforcement Report - Week of May 17, 2023

    17 May 2023

    // FDA

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-may-17-2023-88450.pdf

    FDA
    17 May 2023
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    India-based Hetero's Paxlovid generic gets WHO backing
    India-based Hetero's Paxlovid generic gets WHO backing

    28 Dec 2022

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/india-based-heteros-paxlovid-generic-gets-who-backing-2022-12-27/

    REUTERS
    28 Dec 2022
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    Hetero's Generic Linezolid Receives Approval in the U.S.
    Hetero's Generic Linezolid Receives Approval in the U.S.

    31 Oct 2022

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211813

    FDA
    31 Oct 2022
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    ALL APIs

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    01

    Atomoxetin Hydrochloride

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

    Luxepack
    Not Confirmed
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    Atomoxetin Hydrochloride

    India

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

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    Luxepack
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20246

    Submission : 2007-02-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2020-091 - Rev 01

    Issue Date : 2021-03-19

    Type : Chemical

    Substance Number : 2640

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 229MF10156

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2017-08-08

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0021

    Start Marketing Date : 2002-11-26

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Youngjin Pharmaceutical Co., Ltd.

    Registration Date : 2024-05-01

    Registration Number : No. 3838-3-ND(7)

    Manufacturer Name : Hetero Labs Limited

    Manufacturer Address : Sy.No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana, INDIA

     VMF Others AUDIT
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    02

    Bicalutamide

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

    Luxepack
    Not Confirmed
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    Bicalutamide

    India

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

    arrow
    Luxepack
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18496

    Submission : 2005-07-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2012-254 - Rev 02

    Issue Date : 2023-01-09

    Type : Chemical

    Substance Number : 2196

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 226MF10046

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2014-02-20

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0001

    Start Marketing Date : 1995-10-04

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    03

    Escitalopram Oxalate

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

    Luxepack
    Not Confirmed
    arrow

    Escitalopram Oxalate

    India

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

    arrow
    Luxepack
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-03-17

    Pay. Date : 2013-03-07

    DMF Number : 17960

    Submission : 2004-12-29

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2017-080 - Rev 06

    Issue Date : 2023-10-27

    Type : Chemical

    Substance Number : 2733

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 303MF10125

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2021-08-16

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0007

    Start Marketing Date : 2002-08-14

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Mirae Pharmchem Co., Ltd.

    Registration Date : 2021-04-21

    Registration Number : 20180604-209-J-223(8)

    Manufacturer Name : Hetero Labs Limited

    Manufacturer Address : Survey. No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana State India

     VMF Others AUDIT
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    04

    Irbesartan

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

    Luxepack
    Not Confirmed
    arrow

    Irbesartan

    India

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

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    Luxepack
    Not Confirmed
    • fda
    • EDQM
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-05-27

    Pay. Date : 2016-05-12

    DMF Number : 17507

    Submission : 2004-07-02

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2017-104 - Rev 04

    Issue Date : 2024-03-25

    Type : Chemical

    Substance Number : 2465

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 228MF10007

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2016-01-08

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0005

    Start Marketing Date : 1997-09-30

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    05

    Lamivudine

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

    Luxepack
    Not Confirmed
    arrow

    Lamivudine

    India

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

    arrow
    Luxepack
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-12-27

    Pay. Date : 2012-12-03

    DMF Number : 18252

    Submission : 2005-04-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2008-160 - Rev 02

    Issue Date : 2017-08-10

    Type : Chemical

    Substance Number : 2217

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 229MF10157

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2017-08-08

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0016

    Start Marketing Date : 1995-11-17

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    06

    Levetiracetam

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

    Luxepack
    Not Confirmed
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    Levetiracetam

    India

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-12-26

    Pay. Date : 2012-11-30

    DMF Number : 17738

    Submission : 2004-10-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2014-113 - Rev 01

    Issue Date : 2021-07-19

    Type : Chemical

    Substance Number : 2535

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 302MF10091

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2020-07-29

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0006

    Start Marketing Date : 1999-11-30

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Myungin Pharmaceutical Co., Ltd.

    Registration Date : 2017-08-03

    Registration Number : 20120210-183-I-21-19(6)

    Manufacturer Name : Hetero Labs Limited

    Manufacturer Address : Sy No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana State, India

     VMF Others AUDIT
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    07

    Lisinopril

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

    Luxepack
    Not Confirmed
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    Lisinopril

    India

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-11-11

    Pay. Date : 2012-11-29

    DMF Number : 16510

    Submission : 2003-03-21

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2016-197 - Rev 02

    Issue Date : 2024-07-03

    Type : Chemical

    Substance Number : 1120

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 222MF10145

    Registrant's Address : 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad-500 018, Telangana, INDIA

    Initial Date of Registration : 2010-04-22

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-04

    Valid Till : 2025-07-03

    Written Confirmation Number : WC-0040

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65977-0009

    Start Marketing Date : 1987-12-29

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    08

    Losartan Potassium

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

    Luxepack
    Not Confirmed
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    Losartan Potassium

    India

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-04-30

    Pay. Date : 2013-04-23

    DMF Number : 19988

    Submission : 2006-11-22

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2009-247 - Rev 08

    Issue Date : 2023-07-04

    Type : Chemical

    Substance Number : 2232

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 303MF10096

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2021-06-22

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0008

    Start Marketing Date : 1995-04-14

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    09

    Olanzapine

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

    Luxepack
    Not Confirmed
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    Olanzapine

    India

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-01-24

    Pay. Date : 2013-12-10

    DMF Number : 20591

    Submission : 2007-06-11

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2012-215 - Rev 00

    Issue Date : 2019-01-29

    Type : Chemical

    Substance Number : 2258

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 227MF10065

    Registrant's Address : 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad-500 018, Telangana, INDIA

    Initial Date of Registration : 2015-03-06

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-04

    Valid Till : 2025-07-03

    Written Confirmation Number : WC-0040

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65977-0026

    Start Marketing Date : 1996-09-30

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
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    Registrant Name : Lee Sung International Co., Ltd.

    Registration Date : 2021-05-18

    Registration Number : 20210518-209-J-928

    Manufacturer Name : Hetero Drugs Limited Unit I

    Manufacturer Address : Survey. No. 213, 214 and 255, Bonthapally Village, Gummadidala Mandal, Sangareddy District, Telangana State, India

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    10

    Quetiapine Hemifumarate

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

    Luxepack
    Not Confirmed
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    Quetiapine Hemifumarate

    India

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-07-23

    Pay. Date : 2013-07-12

    DMF Number : 20845

    Submission : 2007-09-12

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2015-153 - Rev 02

    Issue Date : 2023-06-15

    Type : Chemical

    Substance Number : 2541

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 228MF10094

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2016-04-27

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0024

    Start Marketing Date : 1997-09-26

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Mirae Pharmchem Co., Ltd.

    Registration Date : 2021-07-05

    Registration Number : 20120816-172-I-120-06(2)

    Manufacturer Name : Hetero Labs Limited

    Manufacturer Address : Sy.No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, Medak District, Telangana, INDIA

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    EU WC

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    01

    Abacavir IH

    India
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    02

    Abacavir Sulfate (USP)

    India
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    03

    Abacavir Sulphate USP

    India
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    04

    Abacavir Sulfate (USP)

    India
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    05

    Abiraterone Acetate IH/USP

    India
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    Acyclovir (USP)

    India
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    07

    Adefovir Dipivoxil (IH)

    India
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    08

    Afatinib Dimaleate IH

    India
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    Afatinib Dimaleate IH

    India
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    Alfuzosin Hydrochloride (USP...

    India
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    KDMF

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    Abiraterone Acetate

    India
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    Hetero Drugs

    Registrant Name : Hanmi Pharmaceutical Co., Ltd.

    Registration Date : 2023-03-03

    Registration Number : Wed21-22-ND(1)

    Manufacturer Name : Hetero Labs Limited Unit-I

    Manufacturer Address : Survey No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, SangaReddy District.-50231...

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    Abiraterone Acetate

    India
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    Hetero Drugs

    Registrant Name : Leesung International Co., Ltd.

    Registration Date : 2022-12-05

    Registration Number : Wed21-22-ND

    Manufacturer Name : Hetero Labs Limited Unit-I

    Manufacturer Address : Survey No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, SangaReddy District.-50231...

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    amlodipine besylate

    India
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    Hetero Drugs

    Registrant Name : Wonpoong Pharmaceutical Co., Ltd.

    Registration Date : 2012-01-20

    Registration Number : 20120120-130-H-183-36

    Manufacturer Name : Hetero Drugs Limited

    Manufacturer Address : Sy.No.213,214&255, Bonthapally Village, Gummadidala Mandal, Sangareddy District, Tela...

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    amlodipine besylate

    India
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    Hetero Drugs

    Registrant Name : Celltrion Pharmaceutical Co., Ltd.

    Registration Date : 2015-04-15

    Registration Number : 20120120-130-H-183-36(2)

    Manufacturer Name : Hetero Drugs Limited.

    Manufacturer Address : Sy.No.213,214&255, Bonthapally Village, Gummadidala Mandal, Sangareddy District, Tela...

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    amlodipine besylate

    India
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    Hetero Drugs

    Registrant Name : Novartis Korea Co., Ltd.

    Registration Date : 2022-10-18

    Registration Number : 20120120-130-H-183-36(7)

    Manufacturer Name : Hetero Drugs Limited

    Manufacturer Address : Sy.No.213,214&255, Bonthapally Village, Gummadidala Mandal, Sangareddy District, Tela...

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    amlodipine besylate

    India
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    Hetero Drugs

    Registrant Name : Foosung Bio Co., Ltd.

    Registration Date : 2023-09-08

    Registration Number : 20120120-130-H-183-36(8)

    Manufacturer Name : Hetero Drugs Limited

    Manufacturer Address : Sy.No.213,214&255, Bonthapally Village, Gummadidala Mandal, Sangareddy District, Tela...

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    amlodipine besylate

    India
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    Hetero Drugs

    Registrant Name : Inist Farm Co., Ltd.

    Registration Date : 2017-04-17

    Registration Number : 20120120-130-H-183-36(5)

    Manufacturer Name : Hetero Drugs Limited

    Manufacturer Address : Sy.No.213.214&255, Bonthapally Village, Jinnaram Mandal, Medak District, Telangana, I...

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    amlodipine besylate

    India
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    Hetero Drugs

    Registrant Name : Seongui Bio Co., Ltd.

    Registration Date : 2014-03-06

    Registration Number : 20120120-130-H-183-36(1)

    Manufacturer Name : Hetero Drugs Limited

    Manufacturer Address : Sy.No.213,214&255, Bonthapally Village, Gummadidala Mandal, Sangareddy District, Tela...

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    amlodipine besylate

    India
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    Hetero Drugs

    Registrant Name : Leesung International Co., Ltd.

    Registration Date : 2019-10-17

    Registration Number : 20120120-130-H-183-36(6)

    Manufacturer Name : Hetero Drugs Limited

    Manufacturer Address : Sy.No.213,214&255, Bonthapally Village, Gummadidala Mandal, Sangareddy District, Tela...

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    amlodipine besylate

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    Hetero Drugs

    Registrant Name : Sungwoo Chemical Co., Ltd.

    Registration Date : 2016-04-19

    Registration Number : 20120120-130-H-183-36(4)

    Manufacturer Name : Hetero Drugs Limited

    Manufacturer Address : Sy.No.213,214&255, Bonthapally Village, Gummadidala Mandal, Sangareddy District, Tela...

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    Inspections and registrations

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    FDA

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    FDA Audited

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    District Decision : No Action Indicated

    Inspection End Date : 2011-12-09

    Hetero Drugs

    City : Medak District

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2011-12-09

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    FDA Audited

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    District Decision : No Action Indicated

    Inspection End Date : 2011-12-15

    Hetero Drugs

    City : Visakhapatnam

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2011-12-15

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    FDA Audited

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    District Decision : No Action Indicated

    Inspection End Date : 2013-11-29

    Hetero Drugs

    City : Medak District

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2013-11-29

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    FDA Audited

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    District Decision : No Action Indicated

    Inspection End Date : 2017-03-14

    Hetero Drugs

    City : Sangareddy District

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2017-03-14

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    FDA Audited

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    District Decision : No Action Indicated

    Inspection End Date : 2017-02-10

    Hetero Drugs

    City : Visakhapatnam

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

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    Hetero Drugs

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    WHO-GMP

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    Name and address of WHO GMP certified Manufacturer : Hetero Labs Limited (Unit - 11) Vill. Kalyanpur, Chakkan Road, Baddi, Distt. Solan (H.P.)

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    Name and address of WHO GMP certified Manufacturer : Hetero Labs Ltd, Sy.No.10, IDA., Gaddapotharam, Medak Dist.

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    Name and address of WHO GMP certified Manufacturer : Hetero Labs Ltd, Sy.No.10, IDA., Gaddapotharam, Medak Dist.

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    Hetero Drugs

    Name and address of WHO GMP certified Manufacturer : Hetero Labs Ltd, Unit-V, Sy.No. 410&411, APIIC Formulation SEZ, Polepally Village, Jedcherla Mandal, Mahaboobnagar

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    Name and address of WHO GMP certified Manufacturer : Hetero Labs Ltd, Unit-V, Sy.No. 410&411, APIIC Formulation SEZ, Polepally Village, Jedcherla Mandal, Mahaboobnagar

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    Hetero Drugs

    Name and address of WHO GMP certified Manufacturer : Hetero Labs Ltd, Unit-VI, Sy.No. 410&411, APIIC Formulation SEZ, Polepally Village, Jedcherla Mandal, Mahaboobnagar

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    Name and address of WHO GMP certified Manufacturer : Hetero Labs Ltd, Unit-VI, Sy.No. 410&411, APIIC Formulation SEZ, Polepally Village, Jedcherla Mandal, Mahaboobnagar

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    Contact Hetero Drugs and get a quotation

    Hetero Drugs is a supplier offers 488 products (APIs, Excipients or Intermediates).

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