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    Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer

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    INTERVIEW #SpeakPharma

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    “We are working towards providing affordable, high-quality APIs”

    mic“We are working towards providing affordable, high-quality APIs”

    This week, SpeakPharma interviews Dr. N.V. Rao, Chairman and Managing Director of Hyderabad (India)-based Metrochem API, one of the fastest growing manufacturers of active pharmaceutical ingredients (APIs), pellets and intermediates. Dr. Rao talks about Metrochem API’s strong core values and how the company has put in special efforts to meet the needs of the under-cared and neglected communities, with a clear view on sustainable health for all.Can you briefly take us through Metrochem API’s journey? When we embarked on this extraordinary journey in 2004, armed with my expertise in organic chemistry, our vision was unwaveringly clear. We aimed to establish a company that would manufacture top-tier APIs of exceptional quality, all while maintaining cost-effectiveness. Our goal was to cater to the pharmaceutical industry's global needs and position Metrochem as the premier supplier of APIs to customers worldwide. Since our inception, we've strongly believed in creating value through vertical integration. This belief has driven us to continuously invest in infrastructure and manpower, ensuring an abundant supply of key starting materials (KSMs), intermediates, and essential raw materials. Our six state of the art manufacturing facilities are designed and operated in line with this risk mitigation vision. We consider ourselves a pure-play API manufacturing company with an acute awareness of the technical challenges facing the healthcare industry. Our focus has always been on expanding our product portfolio to meet the diverse demands and challenges of the global landscape. We've successfully built a robust product portfolio comprising over 190 products spanning more than 30 distinct therapeutic segments. We excel in handling a variety of niche products that require intricate chemical processes and pose significant challenges, elevating them beyond the typical niche category. Metrochem's journey, from my perspective, has been a relentless pursuit of excellence, innovation, and a commitment to serving the global pharmaceutical industry with integrity and dedication. What are some of the key reasons behind Metrochem API’s success?Our success is credited to our culture, which is founded on innovation, integrity, customer-centricity, and safety. These principles guide every Metrochem team member, and we take immense pride in consistently exceeding expectations.At Metrochem, our organization's foundation is built upon our core values, which we affectionately refer to as "LEADER." Within this framework, 'L' signifies our dedication to 'Learning aspiration,' 'E' embodies our perpetual pursuit of 'Excellence,' 'A' represents our 'Action-oriented' approach, 'D' symbolizes our commitment to 'Discipline,' 'E' underscores our steadfast dedication to 'Ethics and integrity,' and 'R' stands for 'Respect.'We maintain a strong commitment to ethical behavior and actively pursue our social responsibilities. We extend respect to every individual, and consider our stakeholders cherished members of our extended family. Building meaningful relationships with our customers, colleagues, and suppliers is an integral part of Metrochem's identity. These values are deeply ingrained within Metrochem, and guide our daily operations.This robust value system drives our passion for continual growth and self-improvement, both on an individual and at an organizational level. Our enthusiasm is channeled towards achieving operational excellence, with a primary focus on innovation and cost efficiency, all while upholding unwavering quality standards.How has your manufacturing setup grown over the years? Which regulatory authorities have recognized your efforts?Our journey began with a single API facility in Hyderabad, accredited with WHO-GMP, where we initially manufactured two APIs. By 2009, this facility had successfully met the rigorous regulatory standards set by the Pharmaceutical and Medical Devices Agency (PMDA) in Japan. In subsequent years, we not only maintained our WHO-GMP accreditation but also earned recognition from the US Food and Drug Administration (FDA) and COFEPRIS (Mexico Health Authority) in 2013. In 2014, we obtained accreditation from the Korea Food and Drug Administration (KFDA), which is now known as the MFDS (Ministry of Food and Drug Safety).We prioritize adhering to strict regulatory compliance standards. Our commitment is demonstrated through our willingness to undergo regular inspections by esteemed international and national regulatory authorities, including the USFDA, PMDA, WHO-GMP, ANVISA (Brazilian health regulator), and the European Directorate for the Quality of Medicines and Healthcare (EDQM), among other reputable bodies. These recognitions have played a pivotal role in elevating our position as a leading bulk drug manufacturer in India.We are grateful for the regulatory progress we have achieved over the years. At present, Metrochem has submitted 56 US Drug Master Files (USDMFs), 21 Certificates of Suitability (CEPs), and numerous other significant regulatory filings. Notably, we earned the global top ranking for the number of API USDMFs filed in 2022.We currently operate with six state-of-the-art manufacturing facilities located in the states of Telangana and Andhra Pradesh, boasting of a total reactor volume exceeding 3000KL. These manufacturing plants are backed by three cutting-edge, centrally located research and development laboratories, along with a pilot plant designated for testing and development purposes.What are Metrochem API’s target markets? How do you contribute towards sustainable healthcare?Currently, we are fulfilling pharmaceutical needs across over 60 countries. Unlike the typical focus on developed markets, our dedication extends to addressing healthcare inequalities not only in developed markets but also in the underserved, marginalized communities, and less developed nations. Our overarching vision centers on promoting sustainable access to healthcare for everyone.Our partners often say that “quality and affordability go hand in hand at Metrochem”. This has been possible due to our vertically integrated supply chain and our robust manufacturing process that we establish during the initial stages of product development. These processes allow us to not only match the desired specifications of our customers but also give us ample space to stay reasonable in terms of pricing, without hampering the quality standards.We have a wide-reaching market presence that covers diverse geographical regions, including India, the United States, Europe, South East Asia, the Middle East, Africa, Latin America, as well as Asian countries like Japan, Korea, China, Pakistan, Bangladesh, Nepal, and Sri Lanka. Our goal is to transform into a multinational company, from being a multi-state player, in the near future by setting up centers in crucial global locations. This strategic move will give us a substantial advantage in expanding our global presence and operations.We acknowledge our responsibility in promoting global health equity, which serves as a driving force for us to continuously enhance access to life-saving medications worldwide by aligning with varied rigorous delivery schedules.What are Metrochem API’s growth plans?Our objective is to become the foremost choice as an API supply chain partner. We plan to broaden our customer base through exceptional product quality and delivery services. At the same time, we aim to strengthen our global reputation as the most respected API partner,  while diversifying our product portfolio to include candidates among varied therapeutic segments.In addition to having a product portfolio covering 30 different therapeutic segments, we have taken steps to enter the field of oncology by establishing a dedicated facility for the production of oncology APIs. Furthermore, we plan to start manufacturing steroids and peptides soon. Our vision includes expanding into biopharmaceutical manufacturing within the next five years, all while maintaining our commitment to core small molecule API production.Our goal is to achieve sustainable growth and establish ourselves as a leader in bulk drugs, catering to various market segments. To achieve this objective, we are actively working on developing an agile operational system that is aligned with our goals. 

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    09 Oct 2023
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    CORPORATE CONTENT #SupplierSpotlight

    Product List 2023

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    Additional Product List 2023

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    APIs Under Development 2023

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    Corporate Presentation

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    India Pharma 2021 & India Medical Devices 2021

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    India Pharma Bulk Drug Company of the Year Award 2020

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    India Pharma Bulk Drug Company of the Year Award 2020

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    DATA COMPILATION #PharmaFlow

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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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    13 Nov 2025
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    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Every year, the US Food and Drug Administration (FDA) publishes the user fee amounts it will collect from manufacturers of pharmaceuticals, generic drugs, biosimilars and medical devices in the coming financial year. The fee for fiscal year 2025 under the Generic Drug User Fee Act (GDUFA) was published on July 31, 2024.The GDUFA, established in 2012, authorizes FDA to assess and collect fees from drug manufacturers to expedite the delivery of safe, high-quality, and affordable generic drugs to the American public.The FDA’s facility payments list under GDUFA reveals that as of November 14, 2024, 1,397 facilities had paid their registration fees for financial year 2025. Of these facilities, 707 or 50.6 percent are active pharmaceutical ingredients (API) facilities, 405 or 29 percent are finished dosage forms (FDF) facilities, 69 (4.9 percent) are facilities that produce both APIs and FDFs, and 216 (15.5 percent) are contract manufacturing services (CMO) sites.Teva Pharmaceuticals, with 29 facility registrations, led the list of companies, followed by Aurobindo Pharma, Sun Pharma, and Dr. Reddy's Laboratories. Fiscal year Facility Registrations 2016 1,425 2017 1,442 2018 1,269 2019 1,286 2020 1,300 2021 1,340 2022 1,385 2023 1,394 2024 1,447 2025 1,397  Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available)India continues to lead with 396 facilities, US and China follow India maintains its dominance in total facility registrations with the FDA, registering 396 facilities for FY2025. This includes 214 API facilities, 135 FDF facilities, 21 facilities engaged in both API and FDF activities, and 26 CMO facilities.The United States holds the second position with 328 facilities, while China strengthened its third position with 197 facilities.With 214 API facilities, India continues to have the largest share of API manufacturing sites, outmatching the combined total of China (128) and the US (83), which together account for 211 facilities. Among European manufacturers, Italy leads with 59 API manufacturing sites, followed by Spain (30) and Germany (25).The US has maintained its lead in FDF facilities with 143 sites, followed closely by India with 135 sites and China with 45 sites. Country API FDF Both CMO Total India 214 135 21 26 396 US 83 143 13 89 328 China 128 45 12 12 197 Italy 59 3 2 19 83 Germany 25 4 1 15 45 Spain 30 9 1 4 44 Canada 7 17   13 37 Taiwan 9 6 5 4 24 Switzerland 15 4   4 23 France 16     6 22 Japan 18   1   19 United Kingdom 12 1   2 15 Mexico 9 1   1 11 Ireland 5 5   1 11   Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) GDUFA III user fee rates increase across categories for FY25The GDUFA, which was reauthorized on September 30, 2022 (as GDUFA III), continues with provisions that will last until September 30, 2027. In July 2024, the FDA published updated user fee rates for FY2025.The facility fees have seen increases across all categories. API facility fees increased by 3 percent for domestic sites (to US$ 41,580) and 2 percent for foreign sites (to US$ 56,580). FDF facility fees rose by 5 percent for both domestic (to US$ 231,952) and foreign sites (to US$ 246,952). CMO facility fees increased by 5 percent for domestic sites (to US$ 55,668) and 4 percent for foreign sites (to US$ 70,668).Additionally, the fee for large-, medium- and small-sized drug applicants has increased by over 9 percent, compared to the 7 percent increase seen in 2023. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) China leads new facility registrations as FDA records 41 new units in FY25Out of the total 1,397 facilities registered for FY2025, 41 were new registrations (going by Facility FDA Establishment Identifier numbers). China led the way with 13 new facilities, followed closely by India with 11 new facilities, while the US secured the third position with eight new facilities.The new registrations included 15 API facilities, 13 CMO facilities, 12 FDF facilities, and one facility engaged in both API and FDF activities. Chinese companies dominated the new FDF registrations with six facilities: Chengdu Shuode Pharma, Chengdu Suncadia Medicine, Cipla (Jiangsu), GE Healthcare (Shanghai), Luoxin Aurovitas Pharma (Chengdu), and Zhejiang Xianju Pharma.India added two new FDF facilities through Eugia Steriles and Zydus Pharma. Malaysia registered two FDF facilities through Novugen Pharma and Novugen Oncology, while Turkey’s Insud Pharma subsidiary Exeltis and US’ RK Pharma registered one FDF facility each.The 13 new CMO facilities included, Acme Generics, Emcure, Esjay Pharma, Fordoz Pharma, Fourrts Laboratories, Laboratoires KABS, PharmaMax, Quality Packaging Specialists International, Ritsa Pharma, Shanghai Aucyun Pharma, Sichuan Huiyu Pharma, Taejoon Pharm, and Tubilux Pharma.In the API category, the 15 new registrations included Acharya Chemicals, Hainan Poly Pharma, CBL Patras, EUROAPI, Hybio Pharma, Medilux Laboratories, Metrochem API, Purolite, Chengdu Easton Biopharma, Sionc Pharma, Smithfield Bioscience, Xttrium Laboratories, Zhejiang Hengkang Pharma, Moehs Iberica and Shilpa Pharma. Armstrong Pharmaceuticals registered the sole facility for both APIs and FDFs.So far, 92 facilities have not renewed their registration. Among these was a facility owned by Sandoz subsidiary Eon Labs in Wilson, North Carolina (US), which is permanently closed. In fact, the geographical distribution of non-renewals shows that 30 facilities were from the US, while India and China accounted for 14 and nine non-renewals respectively. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) Our viewThe FY 2025 GDUFA facility registration data indicates a continued strong presence of Indian manufacturers in the US generic drug market, particularly in API production. However, China's leadership in new facility registrations, especially in FDF manufacturing, suggests that the global generic drug supply chain landscape may evolve considerably in the coming years. 
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    21 Nov 2024
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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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    COMPANY BIO #AboutSupplier

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    View Metrochem API's portfolio of APIs, Intermediates & Pellets (Semi-finished formulations) & explore Metrochem's R&D activities on PharmaCompass.
    View Metrochem API's portfolio of APIs, Intermediates & Pellets (Semi-finished formulations) & explore Metrochem's R&D activities on PharmaCompass.
    View Metrochem API's portfolio of APIs, Intermediates & Pellets (Semi-finished formulations) & explore Metrochem's R&D activities on PharmaCompass.Q1. What is Metrochem API and what are its product offerings?Metrochem API is one of the...
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    April, 2023
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    View Metrochem API's portfolio of APIs, Intermediates & Pellets (Semi-finished formulations) & explore Metrochem's R&D activities on PharmaCompass.

    View Metrochem API's portfolio of APIs, Intermediates & Pellets (Semi-finished formulations) & explore Metrochem's R&D activities on PharmaCompass.

    View Metrochem API's portfolio of APIs, Intermediates & Pellets (Semi-finished formulations) & explore Metrochem's R&D activities on PharmaCompass.Q1. What is Metrochem API and what are its product offerings?Metrochem API is one of the fastest-growing Indian manufacturers of active pharmaceutical ingredients (APIs), pellets (semi-finished formulations) and intermediates. It provides customized volumes and quality products to its clients all over the world.The company has six dedicated manufacturing facilities for its three core product groups - active pharmaceutical ingredients (APIs), pelletization and intermediates. These facilities, along with a well-equipped, centralized R&D laboratory, allow it to meet the high volume demands of its clients.Metrochem API focuses on innovation across people, processes, products and technology through knowledge exchange and cross-functional collaboration. Its research center in Hyderabad has three fully functional laboratories along with an analytical laboratory. It provides custom research and custom synthesis services as well.Metrochem API's six manufacturing facilities are located in Hyderabad and Visakhapatnam, India. These manufacturing facilities have received approval from several international regulatory agencies such as the USFDA, WHO GMP, Cofepris, KFDA and PMDA.Metrochem API offers the following products:APIs - Metrochem API is one of the leading active pharmaceutical ingredient (API) producers in India. It has its own R&D center and has received international FDA approval. It provides a variety of active pharmaceutical ingredients in multiple therapeutic areas, including antiulceratives, antifungals, antidepressants, antihypertensives, antithrombotic, antihistaminic, antilipemic, antiarthritic, anti-inflammatory, antidiabetic, antibacterial and gastoprokinetic.Pellets - Metrochem API also offers pellets (semi-finished formulations) in multiple therapeutic areas, such as antiulceratives, anti-inflammatory, antihypertensive, antihyperlipidemic, antipsychotic, antiemetic, antithrombotic, antispasmodics, antiasthmatic, immunosuppressant, etc. It also offers blended, combination, taste-masking pellets and micro granules for direct compression.Intermediates- Metrochem API makes various intermediates, including N-Benzylaniline, Pyridine-2-carbaldehyde, 1-bromo-4-chlorobenzene, 2-Hydroxymethyl-4-(3- methoxypropoxy)-3- methylpyridine, etc.Q2. What R&D activities does Metrochem API focus on?Metrochem API's R&D and manufacturing facilities in India have been constructed to meet the highest quality requirements. Metrochem's R&D center conducts research on APIs and intermediates that involve multi-step synthesis. The company has a proven track record of implementing and developing processes and scaling them up from the lab (kilo) to the commercial level.Metrochem can create new products and meet the demands of life science companies all over the world because of its expertise in research, analytical technique development, synthesis of impurities, organic synthesis, multi-step synthesis, custom synthesis, scale-up and technology transfer.The research center at Metrochem complies with cGLP standards and is focused on organic synthesis, custom synthesis services, analytical research, etc. The primary R&D activities of Metrochem API includes the development of active pharmaceutical ingredients (APIs), advanced intermediates and fine chemicals, with continuous process improvement for cost reduction and the long-term sustainability of its various businesses.Metrochem API offers the technical know-how and cutting-edge equipment necessary to develop analytical techniques for assessing the quality of raw materials, advanced intermediates and finished products. With the use of sophisticated instruments like GC-MS/MS, multi nuclei NMR, preparative HPLC, HPLCs with detectors like UV, RI, and PDA, and GCs, it is capable of analyzing the impurity profiles and identifying degradation products in their active compounds.The research center in Hyderabad contains three completely equipped laboratories and a well-equipped analytical laboratory spread across a 1,000 sq. meter area. Custom synthesis at Metrochem API is designed to satisfy the requirements of its customers, be they in the laboratory scale-up, commercial scale-up or post-commercialization stages. Metrochem API provides its extensive services along with a guarantee of quality and reliability. These are made available at a rate and cost that are beneficial to both parties.Q3. Where are Metrochem's manufacturing sites located and what is their regulatory inspection history?Metrochem API has emerged as one of India's fastest-growing pharmaceutical organizations. It has six cutting-edge production facilities situated in Hyderabad and Visakhapatnam, India. It has specialized manufacturing facilities for the production of APIs, pellets (semi-finished formulations) & intermediates, which are supported by a well-equipped, centralized research & development laboratory.Metrochem's manufacturing facilities have been approved by several international regulatory bodies such as ISO 9001-2015, USFDA, WHO GMP, Cofepris, as well as PMDA. The facilities have also been inspected by KFDA.The details about some of Metrochem's production units are as follows:Unit I for APIs - It is a dedicated facility located in Hyderabad, India, specializing in the production of active pharmaceutical ingredients (APIs). The facility has ISO 9001:2015, PMDA, WHO GMP and local GMP certification.The site spans across an area of 1006.25 sq. meters and comprises 10 reactors with a total volume of 30 KL. The facility also includes Class 100000 areas, consisting of 176.00 sq. meters for pharma grade manufacturing and 5.55 sq. meters for sampling and dispensing.Unit II for Pellets - The facility is located in Hyderabad, India, and is a dedicated site for the production of pellets (Semi-finished formulations). The facility has ISO 9001:2015, WHO-GMP and local GMP certification.The site spans an area of 1300.00 square meters and has a total of 13 FBC reactors with a capacity of 6,020 Kgs FBCV. Additionally, there are two Class 100000 areas within the facility., covering a manufacturing area of 634.00 sq. meters, while the sampling & dispensing area covers 8.43 sq. meters.Unit B for Intermediates - This facility is located in Sangareddy, India, and is solely devoted to the production of advanced Intermediates. The facility has received an accreditation of ISO 9001:2015.The site is spread over approximately 6.0 acres and has four reactors, including five GLRS and 35 SSRs, with a total volume capacity of 130 KL. The facility also has one class 100000 area.Unit C for Intermediates -  This facility is also situated in Sangareddy, India, and is dedicated to the production of intermediates. The facility has received accreditations from ISO 9001:2015 and USFDA.The site is spread across an area of 26,040 sq. meters and houses 58 reactors (G-14 and SSR-44), with a total volume capacity of 237.101 KL. The facility also includes Class 100000 areas, including a sampling & dispensing area covering 2.86 sq. meters.Unit IV for APIs & Intermediates - Situated in Visakhapatnam, India, this facility is dedicated to the production of APIs & intermediates. It has ISO 9001:2015 and Schedule-M GMP certifications.The site occupies a total area of 386.50 meters and has 129 reactors with a total volume capacity of 715.53 KL. The facility also includes 11 Class 100000 areas, including the manufacturing area and sampling & dispensing area.Q4. What is Metrochem API's approach to environmental sustainability, and how does the company demonstrate its commitment to environmental management?Metrochem API is a responsible manufacturer of active pharmaceutical ingredients (APIs) and advanced intermediates that recognises and values environmental management as one of its top corporate priorities. It operates all aspects of its business as a responsible steward of the environment.According to Metrochem, environmental management must incorporate the principles and practices for protecting the environment, decreasing pollution and conserving natural resources. It believes companies should comply with the relevant laws and regulations and should be committed towards continual improvement.Metrochem API is committed to environmental sustainability and has made it one of its top corporate priorities. The company adheres to relevant laws and regulations and continuously strives for improvement.Metrochem API has established a framework for setting environmental objectives and targets, which are implemented, documented and communicated to all personnel in the organization. Additionally, Metrochem makes its environmental policy available to the public.

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    HRV Pharma And Metrochem Forge Strategic CDMO Alliance
    HRV Pharma And Metrochem Forge Strategic CDMO Alliance

    21 Nov 2025

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    21 Nov 2025
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    Caplin Point Labs Acquires API Plant In Vizag From Metrochem API
    Caplin Point Labs Acquires API Plant In Vizag From Metrochem API

    22 Nov 2022

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    https://in.marketscreener.com/quote/stock/CAPLIN-POINT-LABORATORIES-46729585/news/Caplin-Point-Laboratories-Limited-acquired-API-plant-in-Vizag-from-Metrochem-API-Private-Limited-42304788/

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    22 Nov 2022
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    ERP company Focus Softnet find partners for growth in South India
    ERP company Focus Softnet find partners for growth in South India

    23 Aug 2022

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    https://mybigplunge.com/business/erp-company-focus-softnet-find-partners-for-growth-in-south-india/

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    23 Aug 2022
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    Metrochem Intermediates Brochure FY Q3, 2021
    Metrochem Intermediates Brochure FY Q3, 2021

    18 Nov 2021

    // CPHI-ONLINE

    https://www.cphi-online.com/brochure/metrochem-api-private-limited-presentation/Metrochem%20Presentation%20FY%20Q3%202021.pdf

    CPHI-ONLINE
    18 Nov 2021
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    How Keka is injecting new efficiencies in pharmaceutical companies
    How Keka is injecting new efficiencies in pharmaceutical companies

    23 Aug 2021

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    23 Aug 2021
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    Metrochem was awarded India Pharma Bulk Drug Company of the Year 2020
    Metrochem was awarded India Pharma Bulk Drug Company of the Year 2020

    01 May 2021

    // CPHI-ONLINE

    https://www.cphi-online.com/metrochem-was-awarded-india-pharma-bulk-drug-news112035.html

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    01 May 2021
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    Metrochem API Private Limited is a supplier offers 302 products (APIs, Excipients or Intermediates).

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