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    Company profile for Ami Lifesciences Private Limited

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    Ami Lifesciences announce offering of Lumateperone Tosylate

    25 Aug 2025

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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, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The company offers a diverse portfolio of APIs, intermediates, key starting materials, and contract bulk manufacturing services. Its advanced manufacturing facilities in Gujarat and Karnataka feature dedicated clean rooms and comply with EU-GMP, WHO-GMP, PMDA, and COFEPRIS standards. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

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    701 to 710, 7th Floor, 1038 Lilleria, Gotri-Sevasi Road, New Alkapuri, Vadodar...
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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, Mr. Girish 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, NMPA, Therapeutic Goods Administration 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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    CEP Q1 2026 Update: CEP 2.0, EDQM’s new guidelines strengthen ecosystem; Indian firms top list of CEPs issued

    CEP Q1 2026 Update: CEP 2.0, EDQM’s new guidelines strengthen ecosystem; Indian firms top list of CEPs issued

    PharmaCompass is introducing a new regulatory update that tracks developments in Certificates of Suitability to the Monographs of the European Pharmacopoeia, referred to as CEPs. These certificates are a critical regulatory instrument in the global pharmaceutical supply chain.Also known as a Certification of Suitability (COS), CEPs are issued by the European Directorate for the Quality of Medicines and HealthCare (EDQM), with or without inspection of the manufacturing site. A CEP must be renewed every five years from its original issue date to remain valid, regardless of any revisions made during the interim period. However, a CEP does not replace Good Manufacturing Practice certification.CEPs are recognized as a trusted reference for API quality, thereby simplifying global registration strategies. Apart from Europe, the CEP system is widely used by many regulatory authorities, including those in Canada, Australia, Brazil, Singapore and South Africa. View CEPs Issued in Q1 2026 (Power BI Dashboard, Free Excel Available)CEP 2.0 enhances regulatory clarity, brings efficiency, global interoperability There are several types of CEPs, depending on the nature of the substance and evaluation. The most common type is the Chemical CEP, which confirms that a chemically synthesized API meets standards for purity and impurity control. Then there are Herbal CEPs for herbal substances and preparations.Another key category is the TSE CEP, which addresses risks associated with transmissible spongiform encephalopathies in animal-derived materials. In addition, there are Combined CEPs that may cover multiple aspects, such as chemical quality, TSE risk, and sterility. However, biological products such as vaccines and blood products fall outside the scope of the CEP framework.In 2023, the CEP system underwent a major transformation with the introduction of CEP 2.0, which marks a shift from a largely document-based system to a more structured, transparent, and digitally aligned model. This makes it easier for companies to manage compliance while improving trust among global regulators.While increasing data and compliance requirements for API manufacturers, CEP 2.0 enables better regulatory clarity, streamlined dossier integration, and stronger global acceptance. Overall, CEP 2.0 is designed to enhance regulatory clarity while making the system more efficient and globally interoperable. View CEPs Issued in Q1 2026 (Power BI Dashboard, Free Excel Available)Indian firms issued maximum CEPs; Sun Pharma and its subsidiaries, Jubilant Biosys top listIndia topped the charts for CEPs issued, both in terms of new CEPs and revisions in the first quarter (Q1) of 2026. Indian companies were issued 81 new CEPs in Q1 2026 (as against 40 in Q1 2025) and 203 revisions (as against 129 in Q1 2025). In comparison, Chinese companies were issued 42 new CEPs in Q1 2026 (against 25 in Q1 2025) and 53 revisions (against 67 in Q1 2025). Italy came a distant third, followed by Germany and Spain.India’s Sun Pharmaceuticals and its subsidiaries topped the list of companies with the maximum number of CEPs issued— while no new CEP was issued, 27 CEPs were revised in Q1 2026. At second place was Jubilant Biosys — 21 CEPs were revised in Q1 2026.In terms of products, the maximum CEPs were issued for amlodipine besylate (a calcium channel blocker used for treating hypertension), followed by sitagliptin phosphate (a type 2 diabetes medicine) and pregabalin (a drug used to treat neuropathic pain, fibromyalgia, seizures, and generalized anxiety disorder). Both amlodipine besylate and sitagliptin phosphate had not been issued new CEPs or revisions in Q1 2025. View CEPs Issued in Q1 2026 (Power BI Dashboard, Free Excel Available)EDQM introduces new guidelines to accelerate CEP assessments The EDQM charges fees for various services related to CEPs that depend on the type of request or regulatory activity involved. In general, fees apply to handling CEP applications, revisions or renewals and for offering technical advice (where applicants seek scientific or regulatory guidance).In March 2026, the EDQM introduced two new guidelines aimed at accelerating CEP assessments. The first is a reliance-based assessment pathway, which allows regulators to leverage prior approvals from trusted authorities, such as those in the EU, UK, Australia, Canada, and the WHO pre-qualification program. The second is a fast-track assessment route designed to expedite reviews in situations such as medicine shortages and to support initiatives like the EU Critical Medicines Act.Timelines have been significantly compressed under these new pathways. Initial evaluations are completed within 46 working days, compared to up to 115 days under the standard procedure. Applicants are given 30 calendar days to respond to queries, after which regulators complete the final assessment within 23 working days.Another important regulatory update relates to electronic submissions. From April 1, 2026, the EDQM will reject non-compliant CEP applications at the point of submission. All applications must include a validated electronic Common Technical Document (eCTD) dossier along with a proper validation report, submitted in line with the updated Common European Submission Portal (CESP) guidelines. Taken together, these developments signal a more rigorous yet efficient CEP ecosystem. View CEPs Issued in Q1 2026 (Power BI Dashboard, Free Excel Available)Our viewThe shift to CEP 2.0 signals a move toward greater transparency, digitalization, and global regulatory alignment. Though enhanced disclosure and stricter e-submission requirements may increase the compliance burden, especially for smaller manufacturers, the long-term gains are expected to be significant. Going forward, companies that invest in data quality and regulatory readiness stand to gain from these changes.
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    DMF filings rise 4.5% in Q3 2025; China holds lead, India records 20% growth in submissions

    DMF filings rise 4.5% in Q3 2025; China holds lead, India records 20% growth in submissions

    The third quarter (Q3) of 2025 witnessed a steady rise in Drug Master File (DMF) submissions to the US Food and Drug Administration (FDA). DMFs are used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug productsA total of 323 Type II DMFs were submitted during this period, as opposed to 309 submissions in Q3 2024, marking an increase of 4.53 percent. This is the second highest number since 2018. In Q1 2025, 339 Type II filings were recorded.Across all DMF types (II, III, IV, and V), 479 DMFs were filed in Q3 2025, compared to 394 in Q3 2024, representing a 21.57 percent increase. Out of the 323 Type II DMFs submitted in Q3 2025, 40 had completed their review by the end of Q3, reflecting a processing lag between submission and review completion. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available)China maintains its lead while India posts double-digit growth in DMF submissions China and India continued to dominate DMF submissions in Q3 2025. China retained the top spot with 153 Type II DMFs, matching its submission count from Q3 2024. India recorded 131 DMFs, marking a 20.18 percent increase over 109 filings during the corresponding period last year.The United States stood a distant third with 17 filings, compared to 13 in Q3 2024. Among European nations, Italy recorded eight DMFs, doubling its 2024 tally. The Netherlands filed four, up from three. Spain submitted only one DMF, as against seven submitted in Q3 2024. Taiwan made three filings, up from one submitted in Q3 2024. Together, India, China and Taiwan accounted for about 88.9 percent of all Type II DMFs filed during the quarter. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) China’s Suzhou Ryway Biotech tops corporate tally; India’s Hetero, Biophore followChina’s Suzhou Ryway Biotech led the company-wise tally with 12 DMF submissions in Q3 2025. The company had not filed any DMFs in Q3 2024.India’s Hetero Group followed with nine DMFs, maintaining the same number of filings as Q3 2024. Biophore India Pharmaceuticals ranked third with six DMFs, doubling its count from three last year.Other notable contributors include Sai Sreyas Pharmaceuticals (India) and Shanghai Haoyuan Chemexpress (China), with five DMFs each. Companies such as SNJ Group, Lunan Pharmaceutical, Allsino Pharmaceutical, Shankus Pharma, Jiangxi Xinganjiang Pharmaceutical, Sunpure Extracts, Lee Pharma, Umedica Laboratories, Linhai Tianyu Pharmaceutical and Maithri Drugs filed four DMFs each. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) Olaparib, semaglutide lead molecular filings; Dr. Reddy’s files DMF for edoxaban & tucatinibDr. Reddy’s Laboratories also featured among key DMF filers in Q3 2025, submitting two DMFs — for edoxaban tosylate monohydrate and tucatinib copovidone. Edoxaban tosylate monohydrate (marketed as Savaysa by Daiichi Sankyo) is a prescription anticoagulant used to reduce the risk of stroke and to treat deep vein thrombosis and pulmonary embolism. Patent exclusivity for Savaysa extends until October 2026 in the United States, with no generic currently available.In terms of molecules, the highest number of DMFs were filed for olaparib, semaglutide, ruxolitinib phosphate, ferric carboxymaltose, and vismodegib, with three DMFs each in Q3 2025.Olaparib, sold by AstraZeneca under the brand name Lynparza, saw DMFs being filed by BDR Lifesciences and Intas Pharmaceuticals from India, and by ScinoPharm Taiwan during the quarter.Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist developed by Novo Nordisk, continued to draw strong interest from API manufacturers. DMFs for semaglutide were filed by three Chinese companies: Yangzhou Aurisco Pharmaceutical, Zhejiang Peptites Biotech, and Fujian Genohope Biotech.Ruxolitinib phosphate, marketed by Incyte as Jakafi, saw three DMFs. Three Indian companies — Alembic Pharmaceuticals, Valary Labs, and Devi Pharmatech — filed DMFs for this API in Q3 2025. Other molecules that received multiple DMF submissions include ferric carboxymaltose (used to treat iron-deficiency anemia) and vismodegib (an oral therapy for basal-cell carcinoma). View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) First-time DMF filings span 17 companies; India leads with nine first-time DMFs The quarter saw first-time DMF filings from 17 companies. India took a lead here with nine first-time DMF filings, followed by China (six), and the US (two).The DMF filings in this quarter included inclisiran sodium (filed by Aurisco Pharmaceutical of China), pacritinib citrate (by TAPI Nl B.V. of the Netherlands), and vosoritide (by Apicore LLC of the US).Out of the 19 first-time DMFs filed in Q3 2025, four completed their Generic Drug User Fee Amendments (GDUFA) review process during the quarter. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) GDUFA fee for FY 2026: The FDA 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.Fee rates for fiscal year 2026 were published on July 30, 2025. FDA has revised fees under GDUFA III across all categories. While there is a slight increase in the DMF fee from US$ 95,084 in 2025 to US$ 102,584 in 2026, the ANDA fee has seen a sharp rise: from US$ 321,920 in 2025 to US$ 358,247 in 2026.FY 2025 and FY 2026 User Fee Rates Generic drug fee category Fees rates for FY 2025 Fees rates for FY 2026 Applications:     Abbreviated New Drug Application (ANDA) US$ 3,21,920 US$ 3,58,247 Drug Master File (DMF) US$ 95,084 US$ 1,02,584 Facilities:     Active Pharmaceutical Ingredient (API)—Domestic US$ 41,580 US$ 43,549 API—Foreign US$ 56,580 US$ 58,549 Finished Dosage Form (FDF)—Domestic US$ 2,31,952 US$ 2,38,943 FDF—Foreign US$ 2,46,952 US$ 2,53,943 Contract Manufacturing Organization (CMO)—Domestic US$ 55,668 US$ 57,346 CMO—Foreign US$ 70,668 US$ 72,346 GDUFA Program:     Large size operation generic drug applicant US$ 18,91,664 US$ 19,18,377 Medium size operation generic drug applicant US$ 7,56,666 US$ 7,67,351 Small business generic drug applicant US$ 1,89,166 US$ 1,91,838 Our viewFor several years prior to the pandemic, India had a lead in Type II DMF submissions. In recent years, China has surpassed India in DMF filings. But Q3 2025 numbers indicate that Indian drugmakers are fast catching up. Since DMFs establish trust in APIs from across the world, we feel this healthy competition between drugmakers from the two countries is good for the global pharmaceutical industry. 
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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 announce offering of Lumateperone Tosylate
    Ami Lifesciences announce offering of Lumateperone Tosylate

    25 Aug 2025

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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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    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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    ALL APIs

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    01

    Ambroxol Hydrochloride

    India

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

    arrow
    Arvo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.
    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2023-168 - Rev 01

    Issue Date : 2025-04-28

    Type : Chemical

    Substance Number : 1489

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 305MF10118

    Registrant's Address : 2nd Floor, Prestige Plaza-40, Urmi Society, Near Urmi Cross Road, BPC Road, Akota, Vadodara-390 020, Gujarat, India

    Initial Date of Registration : 2023-11-01

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-05

    Valid Till : 2028-06-25

    Written Confirmation Number : WC-0054

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Hanmi Pharmaceutical Co., Ltd.

    Registration Date : 2023-02-27

    Registration Number : 20221028-45-B-470-06(1)

    Manufacturer Name : Ami Lifesciences Private Limited

    Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Dist : Vadodara, Gujarat State India

     VMF CN, MX arrow-down
    ✖
    Available Reg. Filing : CN, MX
    AUDIT arrow-down
    AMI Lifesciences

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    02

    Tadalafil

    India

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

    arrow
    Arvo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37995

    Submission : 2023-02-10

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2014-339 - Rev 03

    Issue Date : 2024-02-14

    Type : Chemical

    Substance Number : 2606

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-05

    Valid Till : 2028-06-25

    Written Confirmation Number : WC-0054

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 59680-018

    Start Marketing Date : 2024-11-30

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Taewang Mulsan Co., Ltd.

    Registration Date : 2025-10-29

    Registration Number : 20191014-203-I-583-16(B)

    Manufacturer Name : Ami Lifesciences Pvt. Ltd.

    Manufacturer Address : Block No. 82/B, ECP Road, At & Post. Karakhadi, Tal. - Padra, City – Karakhadi - 391 450, Dist. - Vadodara, Gujarat State, India

     VMF BR, CN, ... arrow-down
    ✖
    Available Reg. Filing : BR, CN, MX
    AUDIT arrow-down
    AMI Lifesciences

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    03

    Tranexamic Acid

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2023-11-13

    Pay. Date : 2023-11-01

    DMF Number : 36336

    Submission : 2021-10-07

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 307MF10056

    Registrant's Address : 2nd Floor, Prestige Plaza-40, Urmi Society, Near Urmi Cross Road, BPC Road, Akota, Vadodara-390 020, Gujarat, India

    Initial Date of Registration : 2025-04-23

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-05

    Valid Till : 2028-06-25

    Written Confirmation Number : WC-0054

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 59680-012

    Start Marketing Date : 2023-07-14

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Aging Life Science Co., Ltd.

    Registration Date : 2024-10-23

    Registration Number : 20241023-210-J-1706

    Manufacturer Name : Ami Lifesciences Private Limited

    Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Dist : Vadodara, Gujarat State, India

     VMF BR, CN, ... arrow-down
    ✖
    Available Reg. Filing : BR, CN, MX
    AUDIT arrow-down
    AMI Lifesciences

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    04

    Brivaracetam

    India

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 36655

    Submission : 2022-01-08

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-05

    Valid Till : 2028-06-25

    Written Confirmation Number : WC-0054

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Aging Life Science Co., Ltd.

    Registration Date : 2023-10-05

    Registration Number : Su434-60-ND

    Manufacturer Name : Ami Lifesciences Private Limited

    Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Dist : Vadodara, Gujarat State, India

     VMF ASMF arrow-down
    ✖
    Available Reg. Filing : ASMF
    AUDIT arrow-down
    AMI Lifesciences

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    05

    Febuxostat

    India

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37996

    Submission : 2023-02-03

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-05

    Valid Till : 2028-06-25

    Written Confirmation Number : WC-0054

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 59680-016

    Start Marketing Date : 2024-09-14

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Aging Life Science Co., Ltd.

    Registration Date : 2022-08-09

    Registration Number : Su434-46-ND

    Manufacturer Name : Ami Lifesciences Private Limited

    Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Dist : Vadodara, Gujarat State India

     VMF MX arrow-down
    ✖
    Available Reg. Filing : MX
    AUDIT arrow-down
    AMI Lifesciences

    Product
    Web Link

    Stock Recap
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    Market
    Place

    06

    Oxcarbazepine

    India

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

    arrow
    Arvo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2025-03-04

    Pay. Date : 2025-01-30

    DMF Number : 38017

    Submission : 2023-03-15

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-108 - Rev 02

    Issue Date : 2025-01-30

    Type : Chemical

    Substance Number : 2577

    Status : Valid

     JDMF EU-WC NDC KDMF VMF CN arrow-down
    ✖
    Available Reg. Filing : CN
    AUDIT arrow-down
    AMI Lifesciences

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    07

    Sacubitril-Valsartan

    India

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

    arrow
    Arvo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37994

    Submission : 2023-03-09

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-05

    Valid Till : 2028-06-25

    Written Confirmation Number : WC-0054

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Hwail Pharmaceutical Co., Ltd.

    Registration Date : 2026-01-26

    Registration Number : Su434-48-ND(1)

    Manufacturer Name : Ami Lifesciences Private Limited@Smilax Laboratories Limited

    Manufacturer Address : Block No.82/B, ECP Road, At & Post, Karakhadi, TAL-Padra City : Karakhadi-391 450, Dist : Vadodara, Gujarat State, India@Plot No. 70&71, JNPharmacity, Parawada(M), Visakhapatnam - 531021, Andhra Pradesh, India

     VMF Others AUDIT arrow-down
    AMI Lifesciences

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    Market
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    08

    Sevelamer Carbonate

    India

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

    arrow
    Arvo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37981

    Submission : 2023-01-25

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-05

    Valid Till : 2028-06-25

    Written Confirmation Number : WC-0054

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Leaders Bio Co., Ltd.

    Registration Date : 2024-10-25

    Registration Number : 20241025-209-J-1648

    Manufacturer Name : Ami Lifesciences Private Limited

    Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Dist : Vadodara, Gujarat State India

     VMF CN arrow-down
    ✖
    Available Reg. Filing : CN
    AUDIT arrow-down
    AMI Lifesciences

    Product
    Web Link

    Stock Recap
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    Market
    Place

    09

    Sevelamer Hydrochloride

    India

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

    arrow
    Arvo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38016

    Submission : 2023-03-01

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-05

    Valid Till : 2028-06-25

    Written Confirmation Number : WC-0054

    Address of the Firm :

    NDC KDMF VMF Others AUDIT arrow-down
    AMI Lifesciences

    Product
    Web Link

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    Market
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    10

    Sitagliptin Phosphate

    India

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

    arrow
    Arvo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37030

    Submission : 2022-05-02

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2024-249 - Rev 00

    Issue Date : 2024-12-19

    Type : Chemical

    Substance Number : 2778

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
    AMI Lifesciences

    Product
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    USDMF

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    01

    Bempedoic Acid

    India
    arrow
    AOCS Annual Meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Ami Lifesciences Private Limited

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37511

    Submission : 2022-10-03

    Status : Active

    Type : II

    AMI Lifesciences

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    Web Link

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    Market
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    02

    Benzonatate

    India
    arrow
    AOCS Annual Meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Ami Lifesciences Private Limited

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39002

    Submission : 2023-12-04

    Status : Active

    Type : II

    AMI Lifesciences

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    03

    Brivaracetam

    India
    arrow
    AOCS Annual Meeting
    Not Confirmed
    • fda
    • EDQM
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    Ami Lifesciences Private Limited

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 36655

    Submission : 2022-01-08

    Status : Active

    Type : II

    AMI Lifesciences

    Product
    Web Link

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    Market
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    04

    Brivaracetam (process-ii)

    India
    arrow
    AOCS Annual Meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Ami Lifesciences Private Limited

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 41918

    Submission : 2025-05-30

    Status : Active

    Type : II

    AMI Lifesciences

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    Market
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    05

    Dapagliflozin Amorphous

    India
    arrow
    AOCS Annual Meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Ami Lifesciences Private Limited

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38009

    Submission : 2023-02-23

    Status : Active

    Type : II

    AMI Lifesciences

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    06

    Dapagliflozin Propanediol Monohydrat...

    India
    arrow
    AOCS Annual Meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Ami Lifesciences Private Limited

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38010

    Submission : 2023-02-23

    Status : Active

    Type : II

    AMI Lifesciences

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    07

    Daprodustat

    India
    arrow
    AOCS Annual Meeting
    Not Confirmed
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    Ami Lifesciences Private Limited

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38516

    Submission : 2023-06-30

    Status : Active

    Type : II

    AMI Lifesciences

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    08

    Desvenlafaxine

    India
    arrow
    AOCS Annual Meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Ami Lifesciences Private Limited

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 43978

    Submission : 2026-03-31

    Status : Active

    Type : II

    AMI Lifesciences

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    09

    Desvenlafaxine Succinate

    India
    arrow
    AOCS Annual Meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Ami Lifesciences Private Limited

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38066

    Submission : 2023-03-03

    Status : Active

    Type : II

    AMI Lifesciences

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    10

    Diacerein

    India
    arrow
    AOCS Annual Meeting
    Not Confirmed
    • fda
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    Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.

    Ami Lifesciences Private Limited

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38766

    Submission : 2023-09-15

    Status : Active

    Type : II

    AMI Lifesciences

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    01

    Ambroxol hydrochloride

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    Ami Lifesciences Private Limited

    Certificate Numbers : CEP 2014-135 - Rev 03

    Status : Valid

    Issue Date : 2024-03-25

    Type : Chemical

    Substance Number : 1489

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    02

    Ambroxol hydrochloride, Process II

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    Ami Lifesciences Private Limited

    Certificate Numbers : CEP 2023-168 - Rev 01

    Status : Valid

    Issue Date : 2025-04-28

    Type : Chemical

    Substance Number : 1489

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    03

    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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    04

    Gliclazide

    India
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    Ami Lifesciences Private Limited

    Certificate Numbers : CEP 2021-465 - Rev 00

    Status : Valid

    Issue Date : 2024-02-15

    Type : Chemical

    Substance Number : 1524

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    Oxcarbazepine

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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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    06

    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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    07

    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

    AMI Lifesciences

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    08

    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

    AMI Lifesciences

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    JDMF

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    01

    Ambroxol Hydrochloride

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    Ami Lifesciences Private Limited

    Registration Number : 305MF10118

    Registrant's Address : 2nd Floor, Prestige Plaza-40, Urmi Society, Near Urmi Cross Road, BPC Road, Akota, Va...

    Initial Date of Registration : 2023-11-01

    Latest Date of Registration : 2023-11-01

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    02

    Tranexamic Acid

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    Ami Lifesciences Private Limited

    Registration Number : 307MF10056

    Registrant's Address : 2nd Floor, Prestige Plaza-40, Urmi Society, Near Urmi Cross Road, BPC Road, Akota, Va...

    Initial Date of Registration : 2025-04-23

    Latest Date of Registration : 2025-04-23

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    03

    Vildagliptin

    India
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    Ami Lifesciences Private Limited

    Registration Number : 307MF10130

    Registrant's Address : 2nd Floor, Prestige Plaza-40, Urmi Society, Near Urmi Cross Road, BPC Road, Akota, Va...

    Initial Date of Registration : 2025-10-29

    Latest Date of Registration : 2025-10-29

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    LISTED APIs

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    Acebrophylline

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    Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The company offers a diverse portfolio of APIs, intermediates, key starting materials, and contract bulk manufacturing services. Its advanced manufacturing faciliti...
    Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The company offers a diverse portfolio of APIs, intermediates, key starting materials, and contract bulk manufacturing services. Its advanced manufacturing facilities in Gujarat and Karnataka feature dedicated clean rooms and comply with EU-GMP, WHO-GMP, PMDA, and COFEPRIS standards. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    01

    Acebrophylline

    India
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    Ami Lifesciences Private Limited

    Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The company offers a diverse portfolio of APIs, intermediates, key starting materials, and contract bulk manufacturing services. Its advanced manufacturing facilities in Gujarat and Karnataka feature dedicated clean rooms and comply with EU-GMP, WHO-GMP, PMDA, and COFEPRIS standards. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

    About the Company : Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The comp...

    AMI Lifesciences

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    Alpha Lipoic Acid

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    Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The company offers a diverse portfolio of APIs, intermediates, key starting materials, and contract bulk manufacturing services. Its advanced manufacturing faciliti...
    Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The company offers a diverse portfolio of APIs, intermediates, key starting materials, and contract bulk manufacturing services. Its advanced manufacturing facilities in Gujarat and Karnataka feature dedicated clean rooms and comply with EU-GMP, WHO-GMP, PMDA, and COFEPRIS standards. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    02

    Alpha Lipoic Acid

    India
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    Ami Lifesciences Private Limited

    Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The company offers a diverse portfolio of APIs, intermediates, key starting materials, and contract bulk manufacturing services. Its advanced manufacturing facilities in Gujarat and Karnataka feature dedicated clean rooms and comply with EU-GMP, WHO-GMP, PMDA, and COFEPRIS standards. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

    About the Company : Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The comp...

    AMI Lifesciences

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    Ambroxol Hydrochloride

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    Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The company offers a diverse portfolio of APIs, intermediates, key starting materials, and contract bulk manufacturing services. Its advanced manufacturing faciliti...
    Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The company offers a diverse portfolio of APIs, intermediates, key starting materials, and contract bulk manufacturing services. Its advanced manufacturing facilities in Gujarat and Karnataka feature dedicated clean rooms and comply with EU-GMP, WHO-GMP, PMDA, and COFEPRIS standards. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    AMI Lifesciences

    03

    Ambroxol Hydrochloride

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    Ami Lifesciences Private Limited

    Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The company offers a diverse portfolio of APIs, intermediates, key starting materials, and contract bulk manufacturing services. Its advanced manufacturing facilities in Gujarat and Karnataka feature dedicated clean rooms and comply with EU-GMP, WHO-GMP, PMDA, and COFEPRIS standards. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

    About the Company : Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The comp...

    AMI Lifesciences

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    Azilsartan Medoxomil Potassium

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    Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The company offers a diverse portfolio of APIs, intermediates, key starting materials, and contract bulk manufacturing services. Its advanced manufacturing faciliti...
    Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The company offers a diverse portfolio of APIs, intermediates, key starting materials, and contract bulk manufacturing services. Its advanced manufacturing facilities in Gujarat and Karnataka feature dedicated clean rooms and comply with EU-GMP, WHO-GMP, PMDA, and COFEPRIS standards. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    AMI Lifesciences

    04

    Azilsartan Medoxomil Potassium

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    Ami Lifesciences Private Limited

    Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The company offers a diverse portfolio of APIs, intermediates, key starting materials, and contract bulk manufacturing services. Its advanced manufacturing facilities in Gujarat and Karnataka feature dedicated clean rooms and comply with EU-GMP, WHO-GMP, PMDA, and COFEPRIS standards. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

    About the Company : Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The comp...

    AMI Lifesciences

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    Bempedoic Acid

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    Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The company offers a diverse portfolio of APIs, intermediates, key starting materials, and contract bulk manufacturing services. Its advanced manufacturing faciliti...
    Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The company offers a diverse portfolio of APIs, intermediates, key starting materials, and contract bulk manufacturing services. Its advanced manufacturing facilities in Gujarat and Karnataka feature dedicated clean rooms and comply with EU-GMP, WHO-GMP, PMDA, and COFEPRIS standards. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    AMI Lifesciences

    05

    Bempedoic Acid

    India
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    Ami Lifesciences Private Limited

    Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The company offers a diverse portfolio of APIs, intermediates, key starting materials, and contract bulk manufacturing services. Its advanced manufacturing facilities in Gujarat and Karnataka feature dedicated clean rooms and comply with EU-GMP, WHO-GMP, PMDA, and COFEPRIS standards. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

    About the Company : Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The comp...

    AMI Lifesciences

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    Benfotiamine

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    Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The company offers a diverse portfolio of APIs, intermediates, key starting materials, and contract bulk manufacturing services. Its advanced manufacturing faciliti...
    Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The company offers a diverse portfolio of APIs, intermediates, key starting materials, and contract bulk manufacturing services. Its advanced manufacturing facilities in Gujarat and Karnataka feature dedicated clean rooms and comply with EU-GMP, WHO-GMP, PMDA, and COFEPRIS standards. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    06

    Benfotiamine

    India
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    Ami Lifesciences Private Limited

    Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The company offers a diverse portfolio of APIs, intermediates, key starting materials, and contract bulk manufacturing services. Its advanced manufacturing facilities in Gujarat and Karnataka feature dedicated clean rooms and comply with EU-GMP, WHO-GMP, PMDA, and COFEPRIS standards. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

    About the Company : Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The comp...

    AMI Lifesciences

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    Benserazide Hydrochloride

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    Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The company offers a diverse portfolio of APIs, intermediates, key starting materials, and contract bulk manufacturing services. Its advanced manufacturing faciliti...
    Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The company offers a diverse portfolio of APIs, intermediates, key starting materials, and contract bulk manufacturing services. Its advanced manufacturing facilities in Gujarat and Karnataka feature dedicated clean rooms and comply with EU-GMP, WHO-GMP, PMDA, and COFEPRIS standards. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    AMI Lifesciences

    07

    Benserazide Hydrochloride

    India
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    Ami Lifesciences Private Limited

    Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The company offers a diverse portfolio of APIs, intermediates, key starting materials, and contract bulk manufacturing services. Its advanced manufacturing facilities in Gujarat and Karnataka feature dedicated clean rooms and comply with EU-GMP, WHO-GMP, PMDA, and COFEPRIS standards. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

    About the Company : Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The comp...

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    Benzonatate

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    Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The company offers a diverse portfolio of APIs, intermediates, key starting materials, and contract bulk manufacturing services. Its advanced manufacturing faciliti...
    Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The company offers a diverse portfolio of APIs, intermediates, key starting materials, and contract bulk manufacturing services. Its advanced manufacturing facilities in Gujarat and Karnataka feature dedicated clean rooms and comply with EU-GMP, WHO-GMP, PMDA, and COFEPRIS standards. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    AMI Lifesciences

    08

    Benzonatate

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    Ami Lifesciences Private Limited

    Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The company offers a diverse portfolio of APIs, intermediates, key starting materials, and contract bulk manufacturing services. Its advanced manufacturing facilities in Gujarat and Karnataka feature dedicated clean rooms and comply with EU-GMP, WHO-GMP, PMDA, and COFEPRIS standards. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

    About the Company : Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The comp...

    AMI Lifesciences

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    Betahistine Dihydrochloride

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    Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The company offers a diverse portfolio of APIs, intermediates, key starting materials, and contract bulk manufacturing services. Its advanced manufacturing faciliti...
    Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The company offers a diverse portfolio of APIs, intermediates, key starting materials, and contract bulk manufacturing services. Its advanced manufacturing facilities in Gujarat and Karnataka feature dedicated clean rooms and comply with EU-GMP, WHO-GMP, PMDA, and COFEPRIS standards. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    AMI Lifesciences

    09

    Betahistine Dihydrochloride

    India
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    Ami Lifesciences Private Limited

    Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The company offers a diverse portfolio of APIs, intermediates, key starting materials, and contract bulk manufacturing services. Its advanced manufacturing facilities in Gujarat and Karnataka feature dedicated clean rooms and comply with EU-GMP, WHO-GMP, PMDA, and COFEPRIS standards. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

    About the Company : Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The comp...

    AMI Lifesciences

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    Bilastine

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    Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The company offers a diverse portfolio of APIs, intermediates, key starting materials, and contract bulk manufacturing services. Its advanced manufacturing faciliti...
    Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The company offers a diverse portfolio of APIs, intermediates, key starting materials, and contract bulk manufacturing services. Its advanced manufacturing facilities in Gujarat and Karnataka feature dedicated clean rooms and comply with EU-GMP, WHO-GMP, PMDA, and COFEPRIS standards. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    10

    Bilastine

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    Ami Lifesciences Private Limited

    Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The company offers a diverse portfolio of APIs, intermediates, key starting materials, and contract bulk manufacturing services. Its advanced manufacturing facilities in Gujarat and Karnataka feature dedicated clean rooms and comply with EU-GMP, WHO-GMP, PMDA, and COFEPRIS standards. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

    About the Company : Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The comp...

    AMI Lifesciences

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    KEY PRODUCTS

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    Services

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    API Manufacturing

    Discover their expertise for : API Manufacturing

    API & Drug Product Development

    Discover their expertise for : API & Drug Product Development

    API Development

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    01

    COMPLEX API DEVELOPMENT

    India
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    Pharma Service : API & Drug Product Development

    Ami Lifesciences Private Limited

    Ami Lifesciences is a contract development and manufacturing organization (CDMO) that offers complex API development services. It has a new R&D center equipped with 60 fume hoods for the development of complex active pharmaceutical ingredients.

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    Category : API Development

    Sub Category : Complex APIs

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    Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.

    Pharma Service : API & Drug Product Development

    COMPLEX API DEVELOPMENT

    Ami Lifesciences is a contract development and manufacturing organization (CDMO) that offers complex API development services. It has a new R&D center equipped with 60 fume hoods for the development of complex active pharmaceutical ingredients.

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    Complex API Development

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    02

    CDMO FOR SMALL MOLECULE APIs

    India
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    Pharma Service : API & Drug Product Development

    Ami Lifesciences Private Limited

    As a contract development and manufacturing organization partner, Ami Lifesciences offers services for small molecule API development and commercial manufacturing. It has the capabilities to scale up the API development process from gm to multi-kg scales.

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    Category : API Development

    Sub Category : Small Molecules

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    Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.

    Pharma Service : API & Drug Product Development

    CDMO FOR SMALL MOLECULE APIs

    As a contract development and manufacturing organization partner, Ami Lifesciences offers services for small molecule API development and commercial manufacturing. It has the capabilities to scale up the API development process from gm to multi-kg scales.

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    CDMO for Small Molecule APIs

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    03

    HPAPI DEVELOPMENT SERVICES

    India
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    Pharma Service : API & Drug Product Development

    Ami Lifesciences Private Limited

    Ami Lifesciences is a CDMO that offers development and manufacturing services for the exclusive synthesis of HPAPIs (highly potent active pharmaceutical ingredients), small molecule APIs, and large molecule APIs.

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    Category : API Development

    Sub Category : High Potency APIs (HPAPIs)

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    Pharma Service : API & Drug Product Development

    HPAPI DEVELOPMENT SERVICES

    Ami Lifesciences is a CDMO that offers development and manufacturing services for the exclusive synthesis of HPAPIs (highly potent active pharmaceutical ingredients), small molecule APIs, and large molecule APIs.

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    04

    API CUSTOM SYNTHESIS

    India
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    Pharma Service : API & Drug Product Development

    Ami Lifesciences Private Limited

    Ami Lifesciences is a CMO and CDMO for exclusive synthesis. It has the expertise, capacity, and capabilities to rapidly meet custom synthesis needs for active pharmaceutical ingredients (APIs) regardless of scale and complexity.

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    Category : API Development

    Sub Category : Custom Synthesis

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    Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.

    Pharma Service : API & Drug Product Development

    API CUSTOM SYNTHESIS

    Ami Lifesciences is a CMO and CDMO for exclusive synthesis. It has the expertise, capacity, and capabilities to rapidly meet custom synthesis needs for active pharmaceutical ingredients (APIs) regardless of scale and complexity.

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    Excipients

    Discover the DDS // excipients from this company

    All Excipients

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    01

    Salcaprozate Sodium Excipient

    India

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

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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 40707

    Submission : 2024-11-26

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    AMI Lifesciences

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    Inspections and registrations

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    FDA

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    01

    FDA Audited

    USA
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    AOCS Annual Meeting
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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2024-09-20

    Ami Lifesciences Private Limited

    City : Vadodara

    State :

    Country/Area : India

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2024-09-20

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    FDA Audited

    USA
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    AOCS Annual Meeting
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2024-09-20

    Ami Lifesciences Private Limited

    City : Vadodara

    State :

    Country/Area : India

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2024-09-20

    AMI Lifesciences

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    EDQM

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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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    GMP Certified

    EU
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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

    AMI Lifesciences

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    WHO-GMP

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    WHO GMP Certified

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    Ami Lifesciences Private Limited

    Name and address of WHO GMP certified Manufacturer : AMI LIFESCIENCES PVT. LTD. KARAKHADI - 391 450

    Country : India

    AMI Lifesciences

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    WHO GMP Certified

    Switzerland
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    Ami Lifesciences Private Limited

    Name and address of WHO GMP certified Manufacturer : AMI LIFESCIENCES PVT. LTD. KARAKHADI - 391 450

    Country : India

    AMI Lifesciences

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    ABOUT THIS PAGE

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