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    Ami Lifesciences files Brivaracetam with TGA, expands

    04 Aug 2025

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    Ami Secures Key CEP Approval For Sitagliptin Phosphate Monohydrate

    17 Mar 2025

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    Ami Lifesciences at J.P. Morgan Healthcare Conference 2025

    17 Mar 2025

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    Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujarat and Karnataka feature dedicated clean rooms for APIs and adhere to international standards like EU-GMP, WHO-GMP, PMDA, and COFEPRIS. Ami serves as a reliable partner for contract development and manufacturing, offering generic APIs to global pharma companies across more than 60 countries.

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    Ami Lifesciences Private Limitedindia-flag Flag
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    India
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    701 to 710, 7th Floor, 1038 Lilleria, Gotri-Sevasi Road, New Alkapuri, Vadodar...
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    +91 2652323046
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    info@amilifesciences.com
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    INTERVIEW #SpeakPharma

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    “We are building capabilities to stay ahead of the curve, and align with future needs of global healthcare”

    mic“We are building capabilities to stay ahead of the curve, and align with future needs of global healthcare”

    This week, SpeakPharma interviews Girish Chovatia, Chairman and Managing Director of Ami Lifesciences. Since its inception in 2006, Ami Lifesciences has emerged as one of the fastest-growing API manufacturers from India, delivering high-quality active pharmaceutical ingredients (APIs) to global partners across more than 60 countries. With a portfolio of 80+ APIs and strong regulatory accreditations, including those from the US Food and Drug Administration (FDA), European Directorate for the Quality of Medicines & HealthCare (EDQM), and the Pharmaceuticals and Medical Devices Agency (PMDA), the company has built a reputation for innovation, reliability, and customer-centricity.Ami Lifesciences’ ability to combine chemistry expertise with forward-looking strategies such as backward integration, custom synthesis, and a growing focus on platform technologies for next-generation therapeutics sets it apart. The company’s state-of-the-art infrastructure, emphasis on regulatory compliance, and quality culture built from the development stage enable it to serve as a trusted partner to leading pharmaceutical companies worldwide.In this interview, Chovatia shares key milestones in Ami Lifesciences’ growth journey, its approach to sustainability and innovation, and vision for expanding into new therapeutic areas and technologies to strengthen their global presence.Ami Lifesciences has grown rapidly since it began API operations in 2006. What have been the key strategic decisions or turning points that have fueled this growth?When we started API operations in 2006, we knew we were entering a highly competitive, globalized market. The key turning points in our journey were rooted in making bold but carefully thought-out strategic decisions. The first was building a quality-first culture from day one. We invested early in strong regulatory systems, which allowed us to secure approvals from agencies like FDA, EDQM and, PMDA, opening global markets.Another major factor was our focus on complex chemistry and high-barrier molecules. Instead of competing only in crowded, generic APIs, we decided to differentiate ourselves by developing technically challenging products where our chemistry expertise could shine.We also expanded our global footprint quickly, entering over 60 countries with a diverse product portfolio. Partnerships with leading pharmaceutical companies gave us both credibility and growth momentum. Each milestone—from our first CEP approval to our first FDA clearance—strengthened our foundation.Most importantly, we built a team that believes in long-term value creation, not shortcuts. That culture of quality, innovation, and customer trust continues to fuel our growth.HIGHLIGHTS// Building quality-first culture/focus on complex chemistry/expanding global footprint/belief in long-term value creationWith 80 APIs and a presence in more than 60 countries, how does Ami Lifesciences ensure regulatory compliance and maintain quality standards across such a diverse global footprint?For us, regulatory compliance is not just a requirement—it is the backbone of our credibility. We’ve built a quality culture that starts from the development stage itself. Our dedicated DQA (Development Quality Assurance) and DRA (Development Regulatory Affairs) teams are involved right from early R&D, ensuring that every molecule is designed with regulatory expectations in mind.All our facilities operate under stringent cGMP (current good manufacturing practices) conditions and are routinely audited by leading authorities, including the FDA, EDQM, PMDA, and multiple global partners. We have built robust systems for documentation, training, and monitoring that keep compliance non-negotiable.Equally important is the mindset—we train our teams to think “compliance-first” in every activity, big or small. Whether it’s a lab scientist, a production engineer, or a QA associate, everyone knows that quality and compliance are paramount.This integration of systems, people and, culture ensures that no matter which market we serve—be it the US, Europe, Japan, or emerging economies—our partners receive products of consistently high standards.HIGHLIGHTS// Compliance backbone of credibility/stringent cGMP conditions/‘compliance-first mindset’/consistency in high standardsHow does Ami Lifesciences’ backward integration across key molecules strengthen cost competitiveness and supply chain assurance for its global clients?Backward integration has been a conscious strategy for us. In today’s environment, customers not only seek high-quality APIs but also security of supply and cost competitiveness. By investing in in-house development and manufacture of key intermediates, we reduce dependency on external vendors and volatile supply chains.This gives us multiple advantages. First, it brings down costs and improves pricing stability, making us a more competitive partner globally. Second, it gives us greater control over timelines—something our clients value tremendously, especially in regulated markets. And third, it ensures resilience; even during global disruptions. We can assure our partners of uninterrupted supply.In a market where reliability is as critical as cost, our backward integration strategy has become a cornerstone of trust and long-term partnerships.HIGHLIGHTS// Backward integration strategy/focus on in-house development/lower costs/control over timelines global footprint/resilience during disruptionsHow is Ami Lifesciences leveraging R&D capabilities and custom synthesis to drive innovation in various therapeutic areas? Our R&D strength has always been at the core of our differentiation. We have over 150 scientists dedicated to developing APIs across complex therapeutic areas such as cardiovascular, anti-diabetic, and central nervous system (CNS) disorders.What sets us apart is our ability to go beyond standard generics. We focus on process innovation—green chemistry, enzymatic applications, and continuous improvement—to make synthesis routes not only cost-effective but also environmentally responsible.Custom synthesis is another pillar. Many of our global partners approach us for tailor-made solutions—whether it’s a new intermediate, a complex chiral molecule, or a high-barrier API. Our flexible R&D infrastructure allows us to design and scale processes efficiently, from grams in the lab to multi-ton manufacturing.By marrying strong chemistry capabilities with customer collaboration, we’ve positioned ourselves as more than a manufacturer—we’re an innovation partner contributing to faster, safer, and more affordable therapies worldwide.HIGHLIGHTS// Strong R&D capabilities/complex therapeutic expertise/green chemistry/custom synthesis solutions/innovation partner for safer therapiesWhat are the next big milestones Ami Lifesciences is targeting in terms of product development and global expansion?Looking ahead, we see the future of Ami Lifesciences in both depth and diversification. On the product side, we are expanding into next-generation therapeutics—with focus areas including oncology APIs, ADC payloads and linkers, short peptides, and select biotechnology platforms. These are high-value, high-science areas where our chemistry expertise and process innovation can create significant impact.We are also investing in platform technologies that can be applied across multiple therapeutic areas, giving us a strategic edge in next-gen molecules.From a global perspective, our milestones include broadening our presence in regulated markets like the US, Europe, and Japan, while simultaneously strengthening our reach in fast-growing markets across Asia, LATAM, and Africa.Our guiding principle is to stay ahead of the curve—building a portfolio and capabilities that align with where global healthcare is heading, not just where it is today.HIGHLIGHTS// Expanding to new-gen therapeutics/investing in platform technologies/broadening presence in regulated markets/staying ahead of the curveCould you elaborate on Ami Lifesciences’ ESG initiatives and how they are integrated into your manufacturing and business strategy?Sustainability is no longer optional—it’s integral to how we do business. At Ami, we’ve made ESG a central pillar of our growth strategy.On the environmental front, we are pioneers in integrating green chemistry and enzymatic applications into our processes. By leveraging biocatalysis, we reduce reliance on harsh chemicals, improve atom economy, and minimize energy usage. Our plants are designed for solvent recovery, water recycling, and energy efficiency, with strong commitments to waste reduction and zero liquid discharge.Socially, we invest heavily in our people and communities. From training and development to ensuring a safe workplace, we believe our people are our greatest asset. Beyond our facilities, we engage in education, healthcare, and environmental initiatives that uplift surrounding communities.On governance, we run with transparency, accountability, and ethics at the forefront. Our systems ensure compliance not just with laws but with global best practices in corporate responsibility.This holistic ESG framework ensures that as we grow, we do so responsibly create value for customers, employees, communities, and the environment alike.HIGHLIGHTS// ESG central to growth strategy/energy and resource efficiency/waste reduction and zero liquid discharge/holistic responsible growthHow does Ami Lifesciences’ manufacturing infrastructure enhance scalability and quality for its clients?Our manufacturing infrastructure is built for both flexibility and scale. Our Karakhadi facility (in Gujarat) is approved by leading agencies such as FDA, EDQM, ANVISA (Brazilian Health Regulatory Agency), NMPA (National Medical Products Administration of China) and KMFDS (Korean Ministry of Food and Drug Safety). Our products are filed in many other regulatory agencies like PMDA of Japan, NMPA of China, Therapeutic Goods Administration of Australia and Health Canada; giving our partners complete confidence in compliance and quality.The facility has multi-purpose production blocks, allowing us to handle diverse chemistries and scale projects seamlessly—from grams in the lab to multi-ton commercial quantities. This scalability is a key advantage for customers looking for a partner that can support them across the product lifecycle.We further strengthen supply reliability through backward integration of intermediates, which secures both cost efficiency and supply assurance.What makes us unique is the way we integrate quality and sustainability into manufacturing. By embedding quality from the development stage and incorporating green chemistry and enzymatic processes, we ensure that our output is not only reliable and compliant but also environmentally responsible.This combination of regulatory strength, scalability, and sustainable practices makes Ami a trusted long-term partner for leading pharma companies worldwide.HIGHLIGHTS// Flexible, scalable manufacturing infrastructure/facility approved by leading regulators/multi-purpose production blocks/quality, sustainability integrated into manufacturing 

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    13 Oct 2025
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    DATA COMPILATION #PharmaFlow

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    DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

    DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

    Drug Master Files, or DMFs, are confidential documents that play a crucial role in the pharmaceutical industry. These files, submitted to the US Food and Drug Administration (FDA), contain detailed information about ingredients, manufacturing processes, and packaging of medicines. They help the FDA oversee drug quality. Of the four types, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs. The third quarter (Q3) of 2024 saw Type II DMF submissions set a new record. A total of 309 Type II DMFs were submitted to the FDA during this period, a substantial 24.6 percent increase over Q3 2023 (with 248 submissions). The second quarter of 2024 too saw a remarkable increase, with 237 Type II DMFs being submitted compared to 178 in Q2 2023. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) China witnesses steep rise in DMF submissions, beats India with maximum filings In Q3 2024, China filed 153 DMFs submissions, marking a substantial 57.7 percent increase from the 97 submissions filed in Q3 2023. India maintained its strong position but fell to the number two spot with 110 DMFs, representing a modest 3.8 percent increase from 106 in Q3 2023. The US, which came a distant third, saw a slight decline in DMF submissions, with 13 filed in Q3 2024, as compared to 18 in Q3 2023. For several years, India had a lead in Type II DMFs. Since 2020, which marked the start of the pandemic, we have noticed a gradual increase in DMFs filed by China. This year, China has surpassed India considerably in the first three quarters. During the first nine months of 2024, China submitted 372, while India filed 286 DMFs. If this lead is maintained in Q4, DMFs from China will surpass that of India in 2024.  Amongst European countries, Spain led with seven DMFs, followed by Italy at four, and Germany and the Netherlands at three each. Among other nations, Japan contributed six while Israel submitted four DMFs. In company-wise tally, China’s Jiangsu East-Mab Biomedical Technology topped the list with an impressive 14 DMFs. On its heels were Indian companies — MSN at 13 DMFs, and Vamsi Labs and Hetero Drugs at nine DMFs each. China’s Porton Pharma and Wuxi AppTec filed five, while Shanghai Keze Yongxin Biotechnology, and Qingdao Glycogene Pharmaceutical contributed four submissions each. India's Maithri Drugs also submitted four. Japanese company Santeja filed five. Overall, Asia accounted for nearly 90 percent, with China contributing a dominant 49.5 percent of all DMF submissions. India was at 35.6 percent, the US at 4.2 percent, while Europe contributed 6.5 percent.  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) Diabetes, obesity, cancer, women’s health drugs emerge as hot molecules in Q3 2024 In terms of molecules, semaglutide (used for the treatment of type 2 diabetes and weight management) and relugolix (to treat prostate cancer and uterine fibroids) saw six DMF filings each in Q3 2024, indicating significant industry interest in these compounds. Following closely behind were semaglutide’s competitor tirzepatide and overactive bladder therapy vibegron, garnering four DMFs each. Finerenone (a non-steroidal drug for chronic kidney disease associated with type 2 diabetes) and voclosporin (an immunosuppressant for lupus nephritis) saw three DMFs each.  The last quarter also witnessed the introduction of 14 molecules with first-time DMFs. Among them were acetoxy empagliflozin, cabozantinib fumarate, tivozanib hydrochloride monohydrate, diosmetin, trilaciclib, clenbuterol hydrochloride, fenoterol hydrobromide, tapinarof and fezolinetant. Fezolinetant, with a DMF from Spain’s Moehs Iberica, is the active ingredient in Astellas’ Veozah, which is the first non-hormonal treatment for menopausal symptoms approved by the FDA. Tapinarof, filed by India’s Maithri Drugs, is used in Vtama, a novel steroid-free psoriasis cream. Other compounds that made their DMF debut include berotralstat, calcium phosphoryl choline chloride, phloroglucinol dihydrate, belumosudil mesylate and trimethylphloroglucinol. During Q2 2024, there were 19 drugs that saw DMF submissions for the first time, including molecules like triptorelin, sorafenib, pralsetinib, trilaciclib dihydrochloride, resmetirom (hepatology) and teneligliptin hydrochloride hydrate (metabolic disorders).  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available)    GDUFA fee for FY 2025: The FDA’s Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry. The fiscal year 2025 fee rates were published on July 31, 2024. The FDA has revised fees under GDUFA III for all categories. While there is a slight increase in the DMF fee from US$ 94,682 in 2024 to US$ 95,084 in 2025, the ANDA fee has witnessed a significant jump — from US$ 252,453 in 2024 to US$ 321,920 in 2025. FY 2024 and FY 2025 User Fee Rates Generic drug fee category Fees rates for FY 2024 Fees rates for FY 2025 Applications: Abbreviated New Drug Application (ANDA) US$ 2,52,453   US$ 3,21,920   Drug Master File (DMF) US$ 94,682 US$ 95,084 Facilities: Active Pharmaceutical Ingredient (API)—Domestic US$ 40,464 US$ 41,580 API—Foreign US$ 55,464 US$ 56,580 Finished Dosage Form (FDF)—Domestic US$ 2,20,427   US$ 2,31,952 FDF—Foreign US$ 2,35,427   US$ 2,46,952 Contract Manufacturing Organization (CMO)—Domestic US$ 52,902 US$ 55,668 CMO—Foreign US$ 67,902 US$ 70,668 GDUFA Program: Large size operation generic drug applicant US$ 17,29,629   US$ 18,91,664 Medium size operation generic drug applicant US$ 6,91,852   US$ 7,56,666 Small business generic drug applicant US$ 1,72,963   US$ 1,89,166 Our view The highlight of the last few quarters has been the sharp rise in Type II DMF filings from China. The submission of a DMF is not required by law or any FDA regulation. FDA’s DMF guideline offers guidance on acceptable approaches to meeting regulatory requirements. Moreover, DMFs establish trust in APIs from lesser-known companies. With a growing emphasis on compliance and quality assurance, it appears that Chinese drug companies are eager to demonstrate their commitment to high standards and build trust in the US market. And that’s good news for the pharmaceutical industry.   
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    Ami Lifesciences files Brivaracetam with TGA, expands
    Ami Lifesciences files Brivaracetam with TGA, expands

    04 Aug 2025

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    Ami Secures Key CEP Approval For Sitagliptin Phosphate Monohydrate
    Ami Secures Key CEP Approval For Sitagliptin Phosphate Monohydrate

    17 Mar 2025

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    Ami Lifesciences at J.P. Morgan Healthcare Conference 2025
    Ami Lifesciences at J.P. Morgan Healthcare Conference 2025

    17 Mar 2025

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    Ami is redefining API excellence through precision manufacturing
    Ami is redefining API excellence through precision manufacturing

    17 Mar 2025

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    Ami Lifesciences Submits US DMF for Tegoprazan
    Ami Lifesciences Submits US DMF for Tegoprazan

    08 Oct 2024

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    Ami Lifesciences Gets CADIFA Approval for Vonoprazan
    Ami Lifesciences Gets CADIFA Approval for Vonoprazan

    02 Aug 2024

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    USDMF

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    Bempedoic Acid

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    GDUFA

    DMF Review : N/A

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    DMF Number : 37511

    Submission : 2022-10-03

    Status : Active

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    Benzonatate

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    DMF Review : N/A

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    DMF Number : 39002

    Submission : 2023-12-04

    Status : Active

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    Brivaracetam

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    DMF Review : N/A

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    DMF Number : 36655

    Submission : 2022-01-08

    Status : Active

    Type : II

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    Brivaracetam (process-ii)

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    DMF Review : N/A

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    DMF Number : 41918

    Submission : 2025-05-30

    Status : Active

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    Dapagliflozin Amorphous

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    DMF Review : N/A

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    DMF Number : 38009

    Submission : 2023-02-23

    Status : Active

    Type : II

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    Dapagliflozin Propanediol Monohydrat...

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    DMF Review : N/A

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    DMF Number : 38010

    Submission : 2023-02-23

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    Daprodustat

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    DMF Review : N/A

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    DMF Number : 38516

    Submission : 2023-06-30

    Status : Active

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    Desvenlafaxine Succinate

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    DMF Number : 38066

    Submission : 2023-03-03

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    Diacerein

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    DMF Review : N/A

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    DMF Number : 38766

    Submission : 2023-09-15

    Status : Active

    Type : II

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    Dicyclomine Hydrochloride

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    DMF Review : N/A

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    DMF Number : 40078

    Submission : 2024-09-21

    Status : Active

    Type : II

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    CEP/COS

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    Ambroxol hydrochloride

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    Certificate Numbers : CEP 2014-135 - Rev 03

    Status : Valid

    Issue Date : 2024-03-25

    Type : Chemical

    Substance Number : 1489

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    Ambroxol hydrochloride, Process II

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    Certificate Numbers : CEP 2023-168 - Rev 01

    Status : Valid

    Issue Date : 2025-04-28

    Type : Chemical

    Substance Number : 1489

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    Betahistine dihydrochloride

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    Ami Lifesciences Private Limited

    Certificate Numbers : CEP 2011-101 - Rev 04

    Status : Valid

    Issue Date : 2024-07-31

    Type : Chemical

    Substance Number : 1665

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    Gliclazide

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    Certificate Numbers : CEP 2021-465 - Rev 00

    Status : Valid

    Issue Date : 2024-02-15

    Type : Chemical

    Substance Number : 1524

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    Oxcarbazepine

    India
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    Ami Lifesciences Private Limited

    Certificate Numbers : CEP 2022-108 - Rev 02

    Status : Valid

    Issue Date : 2025-01-30

    Type : Chemical

    Substance Number : 2577

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    Rivaroxaban

    India
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    Ami Lifesciences Private Limited

    Certificate Numbers : CEP 2022-215 - Rev 01

    Status : Valid

    Issue Date : 2025-03-12

    Type : Chemical

    Substance Number : 2932

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    Sitagliptin phosphate monohydrate

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    Ami Lifesciences Private Limited

    Certificate Numbers : CEP 2022-340 - Rev 00

    Status : Valid

    Issue Date : 2024-05-06

    Type : Chemical

    Substance Number : 2778

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    08

    Sitagliptin phosphate monohydrate, Proce...

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    Ami Lifesciences Private Limited

    Certificate Numbers : CEP 2024-249 - Rev 00

    Status : Valid

    Issue Date : 2024-12-19

    Type : Chemical

    Substance Number : 2778

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    Tadalafil

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    Ami Lifesciences Private Limited

    Certificate Numbers : CEP 2014-339 - Rev 03

    Status : Valid

    Issue Date : 2024-02-14

    Type : Chemical

    Substance Number : 2606

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    Tapentadol hydrochloride

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    Ami Lifesciences Private Limited

    Certificate Numbers : R0-CEP 2021-290 - Rev 00

    Status : Valid

    Issue Date : 2022-11-24

    Type : Chemical

    Substance Number : 3035

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    GMP Certified

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    Ami Lifesciences Private Limited

    Type : GMP Certificates

    Number : IWSC.405.18...

    EudraGMDP Key : 54036

    Country : India

    Issue Date : 2019-05-13

    Post Code : 391450

    NCA Ref : 7

    City : Padra

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    Ami Lifesciences Private Limited

    Type : GMP Certificates

    Number : IT/E/GMP/AP...

    EudraGMDP Key : 36434

    Country : India

    Issue Date : 2016-07-20

    Post Code : 391450

    NCA Ref : 7

    City : Padra

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    Ami Lifesciences Private Limited is a supplier offers 80 products (APIs, Excipients or Intermediates).

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