Company profile for MSN Laboratories

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About

Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Center for Contract Research And Manufacturing Services (CRAMS) located in Hyderaba...
Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Center for Contract Research And Manufacturing Services (CRAMS) located in Hyderabad. MSN has won the trust of more than 250 customers across 65 countries around the globe covering the US, Europe, Latin America, Middle-East, Asia Pacific, Africa and CIS markets. Our product basket offers 100 APIs

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CONTACT DETAILS

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Country
Country
India
Address
Address
MSN House Plot No: C-24 Industrial Estate, Sanathnagar Hyderabad - 18 Telangan...
Telephone
Telephone
+91 40 30438600
Linkedin
Linkedin
youtube
YouTube
Twitter
Twitter

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CPhI WW Frankfurt

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INTERVIEW #SpeakPharma

[Sponsored by another company]
“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 

Impressions: 3026

https://www.pharmacompass.com/speak-pharma/we-are-building-capabilities-to-stay-ahead-of-the-curve-and-align-with-future-needs-of-global-healthcare

PharmaCompass
13 Oct 2025

VLOG #PharmaReel

[Sponsored by another company]
This PharmaReel showcases Coral Drugs, a global partner in end-to-end API manufacturing with more than 27 years of expertise. Supported by vertically integrated cGMP and ISO-compliant facilities, the company is backed by USFDA and EMA certifications, patents, and advanced micronization capabilities.

Impressions: 2549

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DATA COMPILATION #PharmaFlow

[Sponsored by another company]
CDMO Activity Tracker: Veranova, ChemExpress invest in ADC facilities; Cohance to set up oligonucleotide facility in India
The contract development and manufacturing organization (CDMO) sector has emerged as a key partner in new drug development. This was evident from the strategic investments, partnerships, and expansions witnessed in the third quarter (Q3) of 2025. Several CDMOs, such as Cohance Lifesciences, Fermion Oy, Axplora, AGC Pharma Chemicals invested in new projects. Others, including Veranova, Aenova, and Biosynth, expanded capacities, while Ofichem strengthened its footprint with the acquisition of Avivia BV. CDMOs like Fareva, Evonik, and Samsung Biologics forged strategic partnerships for growth. During Q3, the sector continued to adopt artificial intelligence (AI). This prompted the US Food and Drug Administration (FDA) to issue guidance that recognizes the increasing use of AI and data analytics in drug development.  View CDMO Activity Tracker for Q3 2025 (Free Excel Available) Cohance, Veranova invest in bioconjugation suites in US; ChemExpress inks ADC deal Earlier this year, Indian drugmaker Suven Pharmaceuticals Limited merged with  leading CDMO Cohance Lifesciences Limited. The merged entity — Cohance Lifesciences — has invested US$ 10 million in a current Good Manufacturing Practice (cGMP) bioconjugation suite at its subsidiary NJ Bio in Princeton, New Jersey.  NJ Bio is executing a major program for an existing innovator client with multiple antibody-drug conjugate (ADC) candidates. Cohance also announced an INR 230 million (approximately US$ 2.58 million) investment in a cGMP oligonucleotide facility at its Hyderabad (India) site. Veranova’s Devens (Massachusetts) site successfully passed a routine FDA cGMP surveillance inspection with a “No Action Indicated” (NAI) classification. Earlier, the company had initiated a US$ 50 million investment to expand its ADC and bioconjugate capabilities at its Devens site. This includes a 9,000-square-foot facility expansion with a new process development lab, two additional cGMP suites, and state-of-the-art bioconjugation development and manufacturing capabilities. These initiatives strengthen the site’s highly potent API (HPAPI) and ADC development and manufacturing capabilities. Biosynth has expanded its Berlin facility with a new GMP bioconjugation suite. The expansion supports the company’s manufacturing capabilities in conjugate vaccines, conjugate drugs, activated polyethylene glycol (PEGs), and polymer-based drug delivery excipients. ChemExpress, Mabwell Bioscience, and Insilico Medicine have entered into a strategic partnership to jointly develop a large ADC compound library and advance next-generation ADC candidates. The collaboration combines Mabwell’s antibody and ADC technology, Insilico’s AI-powered drug design platform, and ChemExpress’s expertise in linker-payload chemistry. Together, they aim to build a complete, AI-driven ADC development model that accelerates discovery, optimization, and commercialization. This partnership is expected to enhance R&D efficiency and deliver safer, more effective cancer treatments.  View CDMO Activity Tracker for Q3 2025 (Free Excel Available) Fermion, Axplora, Aenova increase API manufacturing capacities; ICE Pharma expands India facility Finnish CDMO Fermion Oy has launched a renovation project at its Hanko (Finland) production site to modernize its API manufacturing capabilities. This expansion is part of Fermion's broader strategy to increase production, enhance flexibility in the manufacturing of both existing and future pharmaceutical products, and enable potential contract manufacturing opportunities. German CDMO Axplora has announced a €6.5 million (approximately US$ 7.5 million) investment to expand its API manufacturing capacity at its Vizag site in India. This expansion aims to strengthen both production capabilities and supply chain resilience. India-based Aarti Pharmalabs has inaugurated the first phase of its greenfield manufacturing facility in Gujarat (India). This expansion aims to bolster Aarti's CDMO and contract manufacturing organization (CMO) services, targeting a revenue goal of INR 10 billion (approximately US$ 112 million). Snapdragon Chemistry, which was acquired by Cambrex in 2023, has expanded its Massachusetts facility to better support peptide drug development and manufacturing. With this upgrade, the company can now handle peptide projects from early development through full-scale manufacturing. Italy-headquartered ICE Pharma has expanded its Raichem facility in India. The new facility will enhance the production of ursodeoxycholic acid (UDCA), an API it derives from chicken bile. This expansion increases the site’s raw UDCA output by 120 metric tons annually. Spain-headquartered AGC Pharma Chemicals inaugurated a new advanced manufacturing plant in Barcelona, with an investment of €110 million (approximately US$ 128.3 million). The plant spans 7,500 square meters and integrates cutting-edge technologies to support the entire drug development lifecycle — from R&D to commercial manufacturing. This represents a 30 percent increase in the company’s production capacity and introduces a segment dedicated to HPAPIs. Germany-headquartered Aenova has launched a new hot melt extrusion platform at its Regensburg (Germany) site. This new equipment enables the production of advanced drug formulations, while handling all testing and quality checks in-house. The move strengthens Aenova’s capabilities in developing and manufacturing complex medications. US-based Cytovance Biologics has introduced in-house formulation development services, enhancing its role as a comprehensive partner for biologic drug developers. These services utilize quality-by-design principles to ensure speed, safety, and precision in current and future client programs.  View CDMO Activity Tracker for Q3 2025 (Free Excel Available)  Ofichem acquires Avivia BV; Evonik, Samsung Biologics form strategic collaborations Europe-based CDMO Ofichem Group announced the acquisition of Avivia BV, a formulation development company in the Netherlands. This acquisition is part of Ofichem’s strategy to become a fully integrated provider of development solutions across both drug substance and drug product, with a focus on complex formulations. Ofichem has also acquired Meribel Pharma Solutions’ site in Uppsala (Sweden) to strengthen its support for biotech innovators and expand its presence in the Nordic region.  Simtra BioPharma Solutions has acquired a 65-acre property near its Bloomington, Indiana (US) facility, adding over 300,000 square feet of potential expansion space. With this site, Simtra now has the flexibility to rapidly expand in the US. German specialty chemicals company Evonik is partnering with German biotech Ethris to develop and commercialize a next-generation lipid nanoparticle (LNP) platform for delivering nucleic acid therapies. Evonik will assist in formulation using Ethris’ SNaP LNP technology. The LNP market alone is projected to grow to US$2.3 billion by 2032. Luxembourg-headquartered Fareva has partnered with Zhaoke Ophthalmology to expand its footprint in China’s pharma market. Zhaoke will act as Fareva’s go-to partner for customers seeking pharmaceutical manufacturing in China. Samsung Biologics has signed a 1.8 trillion won (US$ 1.3 billion) manufacturing agreement with an undisclosed US-based drugmaker. And UK-based eXmoor Pharma has partnered with Anthony Nolan to provide end-to-end services for cell therapy developers.  View CDMO Activity Tracker for Q3 2025 (Free Excel Available)  Our view The global CDMO market, valued at around US$ 255 billion in 2025, is projected to grow to over US$ 465 billion by 2032. Significantly, about 60 percent of new drug approvals in the US and over 65 percent in Europe now involve CDMO support. The developments outlined above underscore the increasing role CDMOs are playing today in bringing about growth and innovation in the pharmaceutical industry.  

Impressions: 271

https://www.pharmacompass.com/radio-compass-blog/cdmo-activity-tracker-veranova-chemexpress-invest-in-adc-facilities-cohance-to-set-up-oligonucleotide-facility-in-india

#PharmaFlow by PHARMACOMPASS
16 Oct 2025

NEWS #PharmaBuzz

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https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211533

FDA
05 Sep 2025

https://www.prnewswire.com/news-releases/msn-marks-major-milestone-with-us-launch-of-sacubitril-and-valsartan-tablets-following-hard-fought-legal-victory-302533161.html

PR NEWSWIRE
19 Aug 2025

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219863

FDA
24 Jul 2025

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216086

FDA
23 Jul 2025

https://www.businesswire.com/news/home/20250609455203/en/U.S.-Court-of-Appeals-for-the-Federal-Circuit-Affirms-Prior-Delaware-District-Court-Rulings-in-Favor-of-Acadia-in-NUPLAZID-pimavanserin-Composition-of-Matter-Patent

BUSINESSWIRE
09 Jun 2025

https://www.fiercepharma.com/pharma/novartis-presses-court-hasty-decision-long-running-entresto-patent-feud-msn

FIERCE PHARMA
07 Jun 2025

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Duloxetine Hydrochloride

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

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Duloxetine Hydrochloride

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Dutasteride

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

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Dutasteride

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Lacosamide

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

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Lacosamide

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Oseltamivir Phosphate

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

FNCE
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Oseltamivir Phosphate

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Voriconazole

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

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Voriconazole

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

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Alfuzosin HCl

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

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Alfuzosin HCl

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Montelukast Sodium

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

FNCE
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Montelukast Sodium

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

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Moxifloxacin Hydrochloride

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

FNCE
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Moxifloxacin Hydrochloride

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

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Pantoprazole Sodium

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

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Pantoprazole Sodium

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

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Rosuvastatin Calcium

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

FNCE
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Rosuvastatin Calcium

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USDMF

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04

Aus. Peptide Conference
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GDUFA

DMF Review : Complete

Rev. Date : 2022-05-16

Pay. Date : 2022-05-06

DMF Number : 34697

Submission : 2020-05-30

Status : Active

Type : II

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Aus. Peptide Conference
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07

Aus. Peptide Conference
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Aus. Peptide Conference
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GDUFA

DMF Review : Complete

Rev. Date : 2021-07-09

Pay. Date : 2021-05-25

DMF Number : 35558

Submission : 2021-02-01

Status : Active

Type : II

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CEP/COS

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Albendazole

CEP/COS

Aus. Peptide Conference
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02

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03

Aus. Peptide Conference
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04

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JDMF

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Aus. Peptide Conference
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MSN Laboratories

Registration Number : 304MF10113

Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...

Initial Date of Registration : 2022-08-03

Latest Date of Registration : 2024-10-10

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02

Aus. Peptide Conference
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MSN Laboratories

Registration Number : 302MF10087

Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...

Initial Date of Registration : 2020-07-22

Latest Date of Registration : 2021-05-10

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Aus. Peptide Conference
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MSN Laboratories

Registration Number : 307MF10038

Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...

Initial Date of Registration : 2025-02-26

Latest Date of Registration : 2025-02-26

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04

Aus. Peptide Conference
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MSN Laboratories

Registration Number : 306MF10106

Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...

Initial Date of Registration : 2024-07-24

Latest Date of Registration : 2024-07-24

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Aus. Peptide Conference
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MSN Laboratories

Registration Number : 229MF10088

Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...

Initial Date of Registration : 2017-04-26

Latest Date of Registration : 2022-11-16

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06

Aus. Peptide Conference
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MSN Laboratories

Registration Number : 230MF10024

Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...

Initial Date of Registration : 2018-02-14

Latest Date of Registration : 2018-02-14

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07

Ezetimibe

JDMF

Aus. Peptide Conference
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MSN Laboratories

Registration Number : 230MF10090

Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...

Initial Date of Registration : 2018-07-26

Latest Date of Registration : 2019-05-16

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Aus. Peptide Conference
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MSN Laboratories

Registration Number : 306MF10101

Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...

Initial Date of Registration : 2024-07-17

Latest Date of Registration : 2024-07-17

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09

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MSN Laboratories

Registration Number : 305MF10092

Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...

Initial Date of Registration : 2023-08-02

Latest Date of Registration : 2023-08-02

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10

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MSN Laboratories

Registration Number : 224MF10094

Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...

Initial Date of Registration : 2012-04-27

Latest Date of Registration : 2021-06-01

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EU WC

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01

Fosapripitant Dimeglumine IH

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Fosapripitant Dimeglumine IH

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MSN Laboratories

Date of Issue : 2025-07-07

Valid Till : 2028-07-14

Written Confirmation Number : WC-0021

Address of the Firm : Sy. Nos, 317,320,321,322,323,6...

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Zanubrutinb IH

Aus. Peptide Conference
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Zanubrutinb IH

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Aus. Peptide Conference
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MSN Laboratories

Date of Issue : 2024-07-01

Valid Till : 2027-06-30

Written Confirmation Number : WC-0586

Address of the Firm : Unit-III, Sy. No. 111/E & 111/...

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03

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04

Aus. Peptide Conference
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05

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06

Aus. Peptide Conference
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07

Aus. Peptide Conference
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08

Aus. Peptide Conference
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09

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10

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KDMF

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01

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MSN Laboratories

Registrant Name : Grace Farm

Registration Date : 2022-04-26

Registration Number : Su674-3-ND

Manufacturer Name : MSN Laboratories Private Limit...

Manufacturer Address : (Unit-II), Sy.No.50, Kardanur (village), Patti (Post), Patancheru (Mandal), Sangaredd...

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02

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MSN Laboratories

Registrant Name : Pharmapia Co., Ltd.

Registration Date : 2022-08-08

Registration Number : Su674-3-ND(1)

Manufacturer Name : MSN Laboratories Private Limit...

Manufacturer Address : (Unit-II), Sy.No.50, Kardanur (village), Patti (Post), Patancheru (Mandal), Sangaredd...

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03

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MSN Laboratories

Registrant Name : Aging Life Science Co., Ltd.

Registration Date : 2023-10-05

Registration Number : Su434-59-ND

Manufacturer Name : MSN Pharmachem Private Limited

Manufacturer Address : Plot. No. 182 to 186, 192-A, 193 to 197 & 212/A,B,C,D, Phase-II, IDA Pashamylaram, Pa...

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MSN Laboratories

Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

Registration Date : 2024-04-03

Registration Number : Su173-48-ND

Manufacturer Name : MSN Laboratories Private Limit...

Manufacturer Address : Sy. No. 317, 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Mandal), ...

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Aus. Peptide Conference
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MSN Laboratories

Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

Registration Date : 2025-07-24

Registration Number : Su173-62-ND

Manufacturer Name : MSN Laboratories Private Limit...

Manufacturer Address : (Unit-ll) Sy. No. 50, 53, 53/A, 54 & 54/A, Kardanur (Village), Patancheru (Mandal), S...

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Aus. Peptide Conference
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MSN Laboratories

Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

Registration Date : 2023-04-28

Registration Number : 20230428-209-J-1471

Manufacturer Name : MSN Pharmachem Private Limited

Manufacturer Address : Plot. No. 182 to 186 ,192-A, 193 to 197 & 212/A,B,C,D,Phase-II, IDA Pashamylaram, Pas...

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MSN Laboratories

Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

Registration Date : 2015-01-14

Registration Number : 20150114-132-H-269-29

Manufacturer Name : MSN Pharmachem Private Limited

Manufacturer Address : Plot. No. 182 to 186 ,192-A, 193 to 197 & 212/A,B,C,D,Phase-II, IDA Pashamylaram, Pas...

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MSN Laboratories

Registrant Name : EQ Bio Co., Ltd.

Registration Date : 2024-02-01

Registration Number : 20150114-132-H-269-29(2)

Manufacturer Name : MSN Pharmachem Private Limited

Manufacturer Address : Plot. No.212/A,B,C,D,Phase-II, IDA Pashamylaram, Pashamylaram(Village), Patancheru(Ma...

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MSN Laboratories

Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

Registration Date : 2011-12-09

Registration Number : 20111209-132-H-186-14

Manufacturer Name : MSN Pharmachem Private Limited

Manufacturer Address : Plot. No. 182 to 186 ,192-A, 193 to 197 & 212/A,B,C,D,Phase-II, IDA Pashamylaram, Pas...

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MSN Laboratories

Registrant Name : Pharmapia Co., Ltd.

Registration Date : 2015-11-17

Registration Number : 20150114-132-H-269-29(1)

Manufacturer Name : MSN Pharmachem Private Limited

Manufacturer Address : Plot. No. 182 to 186 ,192-A, 193 to 197 & 212/A,B,C,D,Phase-II, IDA Pashamylaram, Pas...

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NDC API

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01

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MSN Laboratories

NDC Package Code : 69766-080

Start Marketing Date : 2020-05-29

End Marketing Date : 2025-12-31

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

Marketing Category : BULK INGREDIENT

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02

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Aus. Peptide Conference
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MSN Laboratories

NDC Package Code : 54893-0098

Start Marketing Date : 2020-03-30

End Marketing Date : 2025-12-31

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

Marketing Category : BULK INGREDIENT

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Aus. Peptide Conference
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MSN Laboratories

NDC Package Code : 54893-0070

Start Marketing Date : 2018-02-19

End Marketing Date : 2025-12-31

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

Marketing Category : BULK INGREDIENT

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Aus. Peptide Conference
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MSN Laboratories

NDC Package Code : 54893-0019

Start Marketing Date : 2013-12-24

End Marketing Date : 2025-12-31

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

Marketing Category : BULK INGREDIENT

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Not Confirmed
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Aus. Peptide Conference
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MSN Laboratories

NDC Package Code : 54893-0108

Start Marketing Date : 2021-01-29

End Marketing Date : 2025-12-31

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

Marketing Category : BULK INGREDIENT

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Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
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MSN Laboratories

NDC Package Code : 54893-0507

Start Marketing Date : 2024-03-28

End Marketing Date : 2025-12-31

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

Marketing Category : BULK INGREDIENT

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Aus. Peptide Conference
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MSN Laboratories

NDC Package Code : 54893-0027

Start Marketing Date : 2014-03-26

End Marketing Date : 2025-12-31

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

Marketing Category : BULK INGREDIENT

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Aus. Peptide Conference
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Aus. Peptide Conference
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MSN Laboratories

NDC Package Code : 70600-047

Start Marketing Date : 2023-10-06

End Marketing Date : 2025-12-31

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

Marketing Category : BULK INGREDIENT

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Aus. Peptide Conference
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Aus. Peptide Conference
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MSN Laboratories

NDC Package Code : 54893-0054

Start Marketing Date : 2016-12-31

End Marketing Date : 2025-12-31

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

Marketing Category : BULK INGREDIENT

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Aus. Peptide Conference
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MSN Laboratories

NDC Package Code : 50370-0053

Start Marketing Date : 2016-02-01

End Marketing Date : 2025-12-31

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

Marketing Category : BULK INGREDIENT

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LISTED APIs

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Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Cen...
Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Center for Contract Research And Manufacturing Services (CRAMS) located in Hyderabad. MSN has won the trust of more than 250 customers across 65 countries around the globe covering the US, Europe, Latin America, Middle-East, Asia Pacific, Africa and CIS markets. Our product basket offers 100 APIs
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MSN Laboratories

Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Center for Contract Research And Manufacturing Services (CRAMS) located in Hyderabad. MSN has won the trust of more than 250 customers across 65 countries around the globe covering the US, Europe, Latin America, Middle-East, Asia Pacific, Africa and CIS markets. Our product basket offers 100 APIs

About the Company : Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market...

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Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Cen...
Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Center for Contract Research And Manufacturing Services (CRAMS) located in Hyderabad. MSN has won the trust of more than 250 customers across 65 countries around the globe covering the US, Europe, Latin America, Middle-East, Asia Pacific, Africa and CIS markets. Our product basket offers 100 APIs
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02

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
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MSN Laboratories

Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Center for Contract Research And Manufacturing Services (CRAMS) located in Hyderabad. MSN has won the trust of more than 250 customers across 65 countries around the globe covering the US, Europe, Latin America, Middle-East, Asia Pacific, Africa and CIS markets. Our product basket offers 100 APIs

About the Company : Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market...

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Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Cen...
Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Center for Contract Research And Manufacturing Services (CRAMS) located in Hyderabad. MSN has won the trust of more than 250 customers across 65 countries around the globe covering the US, Europe, Latin America, Middle-East, Asia Pacific, Africa and CIS markets. Our product basket offers 100 APIs
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Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
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MSN Laboratories

Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Center for Contract Research And Manufacturing Services (CRAMS) located in Hyderabad. MSN has won the trust of more than 250 customers across 65 countries around the globe covering the US, Europe, Latin America, Middle-East, Asia Pacific, Africa and CIS markets. Our product basket offers 100 APIs

About the Company : Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market...

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Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Cen...
Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Center for Contract Research And Manufacturing Services (CRAMS) located in Hyderabad. MSN has won the trust of more than 250 customers across 65 countries around the globe covering the US, Europe, Latin America, Middle-East, Asia Pacific, Africa and CIS markets. Our product basket offers 100 APIs
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Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
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MSN Laboratories

Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Center for Contract Research And Manufacturing Services (CRAMS) located in Hyderabad. MSN has won the trust of more than 250 customers across 65 countries around the globe covering the US, Europe, Latin America, Middle-East, Asia Pacific, Africa and CIS markets. Our product basket offers 100 APIs

About the Company : Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market...

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Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Cen...
Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Center for Contract Research And Manufacturing Services (CRAMS) located in Hyderabad. MSN has won the trust of more than 250 customers across 65 countries around the globe covering the US, Europe, Latin America, Middle-East, Asia Pacific, Africa and CIS markets. Our product basket offers 100 APIs
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Not Confirmed
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Aus. Peptide Conference
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MSN Laboratories

Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Center for Contract Research And Manufacturing Services (CRAMS) located in Hyderabad. MSN has won the trust of more than 250 customers across 65 countries around the globe covering the US, Europe, Latin America, Middle-East, Asia Pacific, Africa and CIS markets. Our product basket offers 100 APIs

About the Company : Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market...

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Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Cen...
Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Center for Contract Research And Manufacturing Services (CRAMS) located in Hyderabad. MSN has won the trust of more than 250 customers across 65 countries around the globe covering the US, Europe, Latin America, Middle-East, Asia Pacific, Africa and CIS markets. Our product basket offers 100 APIs
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Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
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MSN Laboratories

Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Center for Contract Research And Manufacturing Services (CRAMS) located in Hyderabad. MSN has won the trust of more than 250 customers across 65 countries around the globe covering the US, Europe, Latin America, Middle-East, Asia Pacific, Africa and CIS markets. Our product basket offers 100 APIs

About the Company : Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market...

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Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Cen...
Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Center for Contract Research And Manufacturing Services (CRAMS) located in Hyderabad. MSN has won the trust of more than 250 customers across 65 countries around the globe covering the US, Europe, Latin America, Middle-East, Asia Pacific, Africa and CIS markets. Our product basket offers 100 APIs
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Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
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MSN Laboratories

Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Center for Contract Research And Manufacturing Services (CRAMS) located in Hyderabad. MSN has won the trust of more than 250 customers across 65 countries around the globe covering the US, Europe, Latin America, Middle-East, Asia Pacific, Africa and CIS markets. Our product basket offers 100 APIs

About the Company : Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market...

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Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Cen...
Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Center for Contract Research And Manufacturing Services (CRAMS) located in Hyderabad. MSN has won the trust of more than 250 customers across 65 countries around the globe covering the US, Europe, Latin America, Middle-East, Asia Pacific, Africa and CIS markets. Our product basket offers 100 APIs
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Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
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MSN Laboratories

Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Center for Contract Research And Manufacturing Services (CRAMS) located in Hyderabad. MSN has won the trust of more than 250 customers across 65 countries around the globe covering the US, Europe, Latin America, Middle-East, Asia Pacific, Africa and CIS markets. Our product basket offers 100 APIs

About the Company : Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market...

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Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Cen...
Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Center for Contract Research And Manufacturing Services (CRAMS) located in Hyderabad. MSN has won the trust of more than 250 customers across 65 countries around the globe covering the US, Europe, Latin America, Middle-East, Asia Pacific, Africa and CIS markets. Our product basket offers 100 APIs
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Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
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MSN Laboratories

Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Center for Contract Research And Manufacturing Services (CRAMS) located in Hyderabad. MSN has won the trust of more than 250 customers across 65 countries around the globe covering the US, Europe, Latin America, Middle-East, Asia Pacific, Africa and CIS markets. Our product basket offers 100 APIs

About the Company : Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market...

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Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Cen...
Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Center for Contract Research And Manufacturing Services (CRAMS) located in Hyderabad. MSN has won the trust of more than 250 customers across 65 countries around the globe covering the US, Europe, Latin America, Middle-East, Asia Pacific, Africa and CIS markets. Our product basket offers 100 APIs
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Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
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MSN Laboratories

Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Center for Contract Research And Manufacturing Services (CRAMS) located in Hyderabad. MSN has won the trust of more than 250 customers across 65 countries around the globe covering the US, Europe, Latin America, Middle-East, Asia Pacific, Africa and CIS markets. Our product basket offers 100 APIs

About the Company : Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market...

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Drugs in Development

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Details:

Sacubitril is a neprilysin inhibitor and valsartan is an angiotensin II receptor blocker (ARB), the combination is indicated for the treatment of chronic heart failure and reduced ejection fraction.


Lead Product(s): Sacubitril Sodium,Valsartan

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Sacubitril-Valsartan-Generic

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 19, 2025

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01

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Aus. Peptide Conference
Not Confirmed

Details : Sacubitril is a neprilysin inhibitor and valsartan is an angiotensin II receptor blocker (ARB), the combination is indicated for the treatment of chronic heart failure and reduced ejection fraction.

Product Name : Sacubitril-Valsartan-Generic

Product Type : Miscellaneous

Upfront Cash : Inapplicable

August 19, 2025

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Details:

Palborest (palbociclib) is a piperazine pyridopyrimidine3, second generation cyclin-dependent kinase inhibitor. Approved in combination with hormonal therapies for hormone receptor positive, human epidermal growth factor receptor negative breast cancer.


Lead Product(s): Palbociclib,Inapplicable

Therapeutic Area: Oncology Brand Name: Palborest

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 17, 2023

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02

Aus. Peptide Conference
Not Confirmed
Aus. Peptide Conference
Not Confirmed

Details : Palborest (palbociclib) is a piperazine pyridopyrimidine3, second generation cyclin-dependent kinase inhibitor. Approved in combination with hormonal therapies for hormone receptor positive, human epidermal growth factor receptor negative breast cancer.

Product Name : Palborest

Product Type : Miscellaneous

Upfront Cash : Inapplicable

January 17, 2023

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Details:

Lacosamide Tablets, USP (generic version of Vimpat), indicated for the prevention and control of seizures, enhances the slow inactivation of voltage-gated sodium channels without affecting the fast inactivation of voltage-gated sodium channels.


Lead Product(s): Lacosamide,Inapplicable

Therapeutic Area: Neurology Brand Name: Lacosamide-Generic

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Breckenridge Pharmaceutical

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 19, 2022

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03

Aus. Peptide Conference
Not Confirmed
Aus. Peptide Conference
Not Confirmed

Details : Lacosamide Tablets, USP (generic version of Vimpat), indicated for the prevention and control of seizures, enhances the slow inactivation of voltage-gated sodium channels without affecting the fast inactivation of voltage-gated sodium channels.

Product Name : Lacosamide-Generic

Product Type : Controlled Substance

Upfront Cash : Inapplicable

April 19, 2022

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Details:

Solifenacin succinatei immediate release tablet is a muscarinic receptor antagonist and Mirabegron capsule is a potent and selective β3-adrenoceptor agonist, indicated for the treatment of overactive bladder.


Lead Product(s): Solifenacin Succinate,Mirabegron

Therapeutic Area: Urology Brand Name: Undisclosed

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 30, 2022

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04

Aus. Peptide Conference
Not Confirmed
Aus. Peptide Conference
Not Confirmed

Details : Solifenacin succinatei immediate release tablet is a muscarinic receptor antagonist and Mirabegron capsule is a potent and selective β3-adrenoceptor agonist, indicated for the treatment of overactive bladder.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

March 30, 2022

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Details:

Under the License Agreement, Vanda granted MSN and Impax a non-exclusive license to manufacture and commercialize MSN's version of HETLIOZ® in the U.S. effective March 13, 2035, unless prior to that date Vanda obtains pediatric exclusivity for HETLIOZ.


Lead Product(s): Tasimelteon,Inapplicable

Therapeutic Area: Genetic Disease Brand Name: Hetlioz

Study Phase: Approved FDFProduct Type: Miscellaneous

Recipient: Vanda Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement January 14, 2022

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05

Aus. Peptide Conference
Not Confirmed
Aus. Peptide Conference
Not Confirmed

Details : Under the License Agreement, Vanda granted MSN and Impax a non-exclusive license to manufacture and commercialize MSN's version of HETLIOZ® in the U.S. effective March 13, 2035, unless prior to that date Vanda obtains pediatric exclusivity for HETLIOZ.

Product Name : Hetlioz

Product Type : Miscellaneous

Upfront Cash : Undisclosed

January 14, 2022

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Details:

Company rolled out the first generic version of Cangrelor is an intravenous platelet P2Y12 antagonist ) used to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis.


Lead Product(s): Cangrelor,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 01, 2021

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06

Aus. Peptide Conference
Not Confirmed
Aus. Peptide Conference
Not Confirmed

Details : Company rolled out the first generic version of Cangrelor is an intravenous platelet P2Y12 antagonist ) used to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

October 01, 2021

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Details:

Molnupiravir is an experimental drug having antiviral properties and is currently under clinical-stage study for COVID treatment.


Lead Product(s): Molnupiravir,Inapplicable

Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 25, 2021

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07

Aus. Peptide Conference
Not Confirmed
Aus. Peptide Conference
Not Confirmed

Details : Molnupiravir is an experimental drug having antiviral properties and is currently under clinical-stage study for COVID treatment.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

May 25, 2021

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Details:

Posaconazole has been launched under the brand name PosaOne as 100 mg Delayed Release tablets and 300 mg injections, respectively. The drug has also been approved by the Drug Controller General of India (DGCI).


Lead Product(s): Posaconazole,Inapplicable

Therapeutic Area: Infections and Infectious Diseases Brand Name: PosaOne

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 22, 2021

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08

Aus. Peptide Conference
Not Confirmed
Aus. Peptide Conference
Not Confirmed

Details : Posaconazole has been launched under the brand name PosaOne as 100 mg Delayed Release tablets and 300 mg injections, respectively. The drug has also been approved by the Drug Controller General of India (DGCI).

Product Name : PosaOne

Product Type : Miscellaneous

Upfront Cash : Inapplicable

May 22, 2021

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FDF Dossiers

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01

Brand Name : ABIRATERONE ACETATE

Aus. Peptide Conference
Not Confirmed
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Brand Name : ABIRATERONE ACETATE

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Aus. Peptide Conference
Not Confirmed

MSN Laboratories

Dosage Form : TABLET;ORAL

Brand Name : ABIRATERONE ACETATE

Dosage Strength : 250MG

Packaging :

Approval Date : 2019-07-10

Application Number : 210686

Regulatory Info : RX

Registration Country : USA

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02

Brand Name : ABIRATERONE ACETATE

Aus. Peptide Conference
Not Confirmed
arrow

Brand Name : ABIRATERONE ACETATE

arrow
Aus. Peptide Conference
Not Confirmed

MSN Laboratories

Dosage Form : TABLET;ORAL

Brand Name : ABIRATERONE ACETATE

Dosage Strength : 500MG

Packaging :

Approval Date : 2024-04-24

Application Number : 210686

Regulatory Info : RX

Registration Country : USA

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03

Brand Name : ACALABRUTINIB

Aus. Peptide Conference
Not Confirmed
arrow

Brand Name : ACALABRUTINIB

arrow
Aus. Peptide Conference
Not Confirmed

MSN Laboratories

Dosage Form : CAPSULE

Brand Name : ACALABRUTINIB

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number : 216833

Regulatory Info :

Registration Country : USA

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04

Brand Name : ACYCLOVIR

Aus. Peptide Conference
Not Confirmed
arrow

Brand Name : ACYCLOVIR

arrow
Aus. Peptide Conference
Not Confirmed

MSN Laboratories

Dosage Form : SUSPENSION;ORAL

Brand Name : ACYCLOVIR

Dosage Strength : 200MG/5ML

Packaging :

Approval Date : 2023-03-09

Application Number : 217393

Regulatory Info : RX

Registration Country : USA

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05

Brand Name : AFATINIB

Aus. Peptide Conference
Not Confirmed
arrow

Brand Name : AFATINIB

arrow
Aus. Peptide Conference
Not Confirmed

MSN Laboratories

Dosage Form : TABLET;ORAL

Brand Name : AFATINIB

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number : 210804

Regulatory Info :

Registration Country : USA

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06

Brand Name : AFATINIB

Aus. Peptide Conference
Not Confirmed
arrow

Brand Name : AFATINIB

arrow
Aus. Peptide Conference
Not Confirmed

MSN Laboratories

Dosage Form : TABLET;ORAL

Brand Name : AFATINIB

Dosage Strength : 30MG

Packaging :

Approval Date :

Application Number : 210804

Regulatory Info :

Registration Country : USA

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07

Brand Name : AFATINIB

Aus. Peptide Conference
Not Confirmed
arrow

Brand Name : AFATINIB

arrow
Aus. Peptide Conference
Not Confirmed

MSN Laboratories

Dosage Form : TABLET;ORAL

Brand Name : AFATINIB

Dosage Strength : 40MG

Packaging :

Approval Date :

Application Number : 210804

Regulatory Info :

Registration Country : USA

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08

Brand Name : ALBENDAZOLE

Aus. Peptide Conference
Not Confirmed
arrow

Brand Name : ALBENDAZOLE

arrow
Aus. Peptide Conference
Not Confirmed

MSN Laboratories

Dosage Form : TABLET;ORAL

Brand Name : ALBENDAZOLE

Dosage Strength : 200MG

Packaging :

Approval Date : 2021-01-21

Application Number : 213435

Regulatory Info : RX

Registration Country : USA

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09

Brand Name : ALOGLIPTIN AND METFO...

Aus. Peptide Conference
Not Confirmed
arrow

Brand Name : ALOGLIPTIN AND METFO...

arrow
Aus. Peptide Conference
Not Confirmed

MSN Laboratories

Dosage Form : TABLET; ORAL

Brand Name : ALOGLIPTIN AND METFORMIN ...

Dosage Strength : 12.5MG/500MG

Packaging :

Approval Date :

Application Number : 210212

Regulatory Info :

Registration Country : USA

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10

Brand Name : ALOGLIPTIN AND METFO...

Aus. Peptide Conference
Not Confirmed
arrow

Brand Name : ALOGLIPTIN AND METFO...

arrow
Aus. Peptide Conference
Not Confirmed

MSN Laboratories

Dosage Form : TABLET; ORAL

Brand Name : ALOGLIPTIN AND METFORMIN ...

Dosage Strength : 12.5MG/1000MG

Packaging :

Approval Date :

Application Number : 210212

Regulatory Info :

Registration Country : USA

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FDA Orange Book

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01

Brand Name : ABIRATERONE ACETATE

Aus. Peptide Conference
Not Confirmed
arrow

Brand Name : ABIRATERONE ACETATE

Aus. Peptide Conference
Not Confirmed
arrow

MSN Laboratories

Dosage Form : TABLET; ORAL

Proprietary Name : ABIRATERONE ACETATE

Dosage Strength : 250MG

Approval Date : 2019-07-10

Application Number : 210686

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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02

Brand Name : ABIRATERONE ACETATE

Aus. Peptide Conference
Not Confirmed
arrow

Brand Name : ABIRATERONE ACETATE

Aus. Peptide Conference
Not Confirmed
arrow

MSN Laboratories

Dosage Form : TABLET; ORAL

Proprietary Name : ABIRATERONE ACETATE

Dosage Strength : 500MG

Approval Date : 2024-04-24

Application Number : 210686

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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03

Brand Name : ACALABRUTINIB

Aus. Peptide Conference
Not Confirmed
arrow

Brand Name : ACALABRUTINIB

Aus. Peptide Conference
Not Confirmed
arrow

MSN Laboratories

Dosage Form : CAPSULE

Proprietary Name : ACALABRUTINIB

Dosage Strength : 100MG

Approval Date :

Application Number : 216833

RX/OTC/DISCN :

RLD :

TE Code :

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04

Brand Name : ACYCLOVIR

Aus. Peptide Conference
Not Confirmed
arrow

Brand Name : ACYCLOVIR

Aus. Peptide Conference
Not Confirmed
arrow

MSN Laboratories

Dosage Form : SUSPENSION; ORAL

Proprietary Name : ACYCLOVIR

Dosage Strength : 200MG/5ML

Approval Date : 2023-03-09

Application Number : 217393

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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05

Brand Name : AFATINIB

Aus. Peptide Conference
Not Confirmed
arrow

Brand Name : AFATINIB

Aus. Peptide Conference
Not Confirmed
arrow

MSN Laboratories

Dosage Form : TABLET; ORAL

Proprietary Name : AFATINIB

Dosage Strength : 20MG

Approval Date :

Application Number : 210804

RX/OTC/DISCN :

RLD :

TE Code :

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06

Brand Name : AFATINIB

Aus. Peptide Conference
Not Confirmed
arrow

Brand Name : AFATINIB

Aus. Peptide Conference
Not Confirmed
arrow

MSN Laboratories

Dosage Form : TABLET; ORAL

Proprietary Name : AFATINIB

Dosage Strength : 30MG

Approval Date :

Application Number : 210804

RX/OTC/DISCN :

RLD :

TE Code :

blank

07

Brand Name : AFATINIB

Aus. Peptide Conference
Not Confirmed
arrow

Brand Name : AFATINIB

Aus. Peptide Conference
Not Confirmed
arrow

MSN Laboratories

Dosage Form : TABLET; ORAL

Proprietary Name : AFATINIB

Dosage Strength : 40MG

Approval Date :

Application Number : 210804

RX/OTC/DISCN :

RLD :

TE Code :

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08

Brand Name : ALBENDAZOLE

Aus. Peptide Conference
Not Confirmed
arrow

Brand Name : ALBENDAZOLE

Aus. Peptide Conference
Not Confirmed
arrow

MSN Laboratories

Dosage Form : TABLET; ORAL

Proprietary Name : ALBENDAZOLE

Dosage Strength : 200MG

Approval Date : 2021-01-21

Application Number : 213435

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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09

Brand Name : ALOGLIPTIN AND METFO...

Aus. Peptide Conference
Not Confirmed
arrow

Brand Name : ALOGLIPTIN AND METFO...

Aus. Peptide Conference
Not Confirmed
arrow

MSN Laboratories

Dosage Form : TABLET; ORAL

Proprietary Name : ALOGLIPTIN AND METFORMIN...

Dosage Strength : 12.5MG/500MG

Approval Date :

Application Number : 210212

RX/OTC/DISCN :

RLD :

TE Code :

blank

10

Brand Name : ALOGLIPTIN AND METFO...

Aus. Peptide Conference
Not Confirmed
arrow

Brand Name : ALOGLIPTIN AND METFO...

Aus. Peptide Conference
Not Confirmed
arrow

MSN Laboratories

Dosage Form : TABLET; ORAL

Proprietary Name : ALOGLIPTIN AND METFORMIN...

Dosage Strength : 12.5MG/1000MG

Approval Date :

Application Number : 210212

RX/OTC/DISCN :

RLD :

TE Code :

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Excipients

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All Excipients

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01

Calcobutrol Sodium

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

Aus. Peptide Conference
Not Confirmed
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Calcobutrol Sodium

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

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Aus. Peptide Conference
Not Confirmed
USDMF arrow-down Click Us! arrow-down
CEP/COS JDMF EU-WC NDC arrow-down KDMF VMF Others AUDIT
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Inspections and registrations

Upload your audits for free, ask us

FDA

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01

FDA Audited

USA
Aus. Peptide Conference
Not Confirmed
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FDA Audited

USA
arrow
Aus. Peptide Conference
Not Confirmed

MSN Laboratories

City : Rangareddy District

State :

Country/Area : India

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2017-07-21

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02

FDA Audited

USA
Aus. Peptide Conference
Not Confirmed
arrow

FDA Audited

USA
arrow
Aus. Peptide Conference
Not Confirmed

MSN Laboratories

City : Chandampet

State :

Country/Area : India

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-06-30

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03

FDA Audited

USA
Aus. Peptide Conference
Not Confirmed
arrow

FDA Audited

USA
arrow
Aus. Peptide Conference
Not Confirmed

MSN Laboratories

City : Patancheru, Medak Distric...

State :

Country/Area : India

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2015-06-10

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04

FDA Audited

USA
Aus. Peptide Conference
Not Confirmed
arrow

FDA Audited

USA
arrow
Aus. Peptide Conference
Not Confirmed

MSN Laboratories

City : Medak District

State :

Country/Area : India

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2015-04-03

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05

FDA Audited

USA
Aus. Peptide Conference
Not Confirmed
arrow

FDA Audited

USA
arrow
Aus. Peptide Conference
Not Confirmed

MSN Laboratories

City : Medak District

State :

Country/Area : India

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2015-02-06

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06

FDA Audited

USA
Aus. Peptide Conference
Not Confirmed
arrow

FDA Audited

USA
arrow
Aus. Peptide Conference
Not Confirmed

MSN Laboratories

City : Bollaram

State :

Country/Area : India

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2014-10-31

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07

FDA Audited

USA
Aus. Peptide Conference
Not Confirmed
arrow

FDA Audited

USA
arrow
Aus. Peptide Conference
Not Confirmed

MSN Laboratories

City : Patancheru, Medak Distric...

State :

Country/Area : India

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2014-06-13

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08

FDA Audited

USA
Aus. Peptide Conference
Not Confirmed
arrow

FDA Audited

USA
arrow
Aus. Peptide Conference
Not Confirmed

MSN Laboratories

City : Nalgonda District

State :

Country/Area : India

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2013-08-30

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09

FDA Audited

USA
Aus. Peptide Conference
Not Confirmed
arrow

FDA Audited

USA
arrow
Aus. Peptide Conference
Not Confirmed

MSN Laboratories

City : Medak District

State :

Country/Area : India

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2012-03-09

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10

FDA Audited

USA
Aus. Peptide Conference
Not Confirmed
arrow

FDA Audited

USA
arrow
Aus. Peptide Conference
Not Confirmed

MSN Laboratories

City : Patancheru, Medak Distric...

State :

Country/Area : India

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2011-08-05

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GDUFA

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01

GDUFA fees paid

USA
Aus. Peptide Conference
Not Confirmed
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GDUFA fees paid

USA
arrow
Aus. Peptide Conference
Not Confirmed

API Manufacturer : API MANUFACTURE

FDF Manufacturer :

Facility Name : MSN LABORATORIES PRIVATE LIMIT...

Business Address : Sy. No. 317, 320, 321, 322, ...

FEI Number : 3005254981

Country : India

Paid in : 2019

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02

GDUFA fees paid

USA
Aus. Peptide Conference
Not Confirmed
arrow

GDUFA fees paid

USA
arrow
Aus. Peptide Conference
Not Confirmed

API Manufacturer : API MANUFACTURE

FDF Manufacturer :

Facility Name : MSN LABORATORIES PRIVATE LIMIT...

Business Address : Unit-II, Sy. No. 50, Kardanu...

FEI Number : 3008656542

Country : India

Paid in : 2019

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03

GDUFA fees paid

USA
Aus. Peptide Conference
Not Confirmed
arrow

GDUFA fees paid

USA
arrow
Aus. Peptide Conference
Not Confirmed

API Manufacturer :

FDF Manufacturer : FDF MANUFACTURE

Facility Name : MSN Laboratories Private Limit...

Business Address : Survey No. 1277 & 1319 to 13...

FEI Number : 3011033544

Country : India

Paid in : 2019

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04

GDUFA fees paid

USA
Aus. Peptide Conference
Not Confirmed
arrow

GDUFA fees paid

USA
arrow
Aus. Peptide Conference
Not Confirmed

API Manufacturer : API MANUFACTURE

FDF Manufacturer :

Facility Name : MSN ORGANICS PRIVATE LIMITED

Business Address : Sy. No. 224/A, Bibinagar (Vi...

FEI Number : 3008822771

Country : India

Paid in : 2019

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05

GDUFA fees paid

USA
Aus. Peptide Conference
Not Confirmed
arrow

GDUFA fees paid

USA
arrow
Aus. Peptide Conference
Not Confirmed

API Manufacturer : API MANUFACTURE

FDF Manufacturer :

Facility Name : MSN PHARMACHEM PRIVATE LIMITED

Business Address : Plot No.: 212/ A,B,C,D, Phas...

FEI Number : 3006165229

Country : India

Paid in : 2019

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MSN Laboratories is a supplier offers 610 products (APIs, Excipients or Intermediates).

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