Company profile for MSN Laboratories

PharmaCompass

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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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Events

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CPhI North America

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Meeting

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INTERVIEW #SpeakPharma

[Sponsored by another company]
Alchem NicSelect™ grants customers royalty-free access to T-MAX™ tech for 3-in-1 vape satisfaction in flavour-restricted markets
With increasing flavour bans in key markets, vaping brands are facing significant challenges in providing satisfying alternatives to vapers and smokers looking to transition. Recognising this need, Alchem NicSelect™ is making a bold move by offering its key customers royalty-free and unrestricted geographical access to its revolutionary T-MAX™ technology.“At Alchem NicSelect™, we understand the urgency for vaping brands to adapt to new regulations without compromising on satisfaction. By offering royalty-free access to T-MAX™ technology, we empower our customers to provide the closest cigarette-like experience possible, even in markets with strict flavour restrictions,” said Riccardo Santambrogio, Europe Sales Manager.HIGHLIGHTS// offering royalty-free access to T-MAX™ technology/ unrestricted geographical access/ closest cigarette-like experience Addressing the biggest barrier: Nicotine satisfactionOne of the primary reasons many vapers are dissatisfied and smokers struggle to switch to vaping is that traditional nicotine solutions fail to replicate the rapid satisfaction provided by cigarettes. Nicotine replacement therapies (NRTs) and even conventional vaping products often lack the immediate nicotine hit, throat feel, and overall experience that smokers are accustomed to. T-MAX™ solves this problem by engineering a nicotine experience that closely mimics cigarette consumption without relying on flavours.T-MAX™ provides a unique 3-in-1 approach:1. The Speed of a Cigarette – Rapid nicotine delivery and rush within seconds for immediate satisfaction.2. The Power of Nicotine Salts – A stronger perceived nicotine effect without exceeding legal limits (20 mg/ml nicotine limit under the European Tobacco Products Directive). With T-MAX™, 8 mg/ml feels like 20 mg/ml, and 14 mg/ml feels like 40 mg/ml.3. The Throat Hit of Freebase Nicotine – Especially in a flavour-free formulation, the combined ingredients in T-MAX™ deliver an even more satisfying throat feel than expected from nicotine base, much closer to and more familiar with a cigarette throat feel that habitual smokers recognise.HIGHLIGHTS// unique 3-in-1 approach/ rush within seconds/ stronger perceived nicotine effect without exceeding legal limits/ more satisfying throat feel that habitual smokers recogniseNo flavour, but not less satisfyingWhile flavours have traditionally played a role in vaping adoption, market realities are shifting. With flavour bans spreading across regions, brands need solutions that deliver satisfaction without relying on taste. Consumer research has shown that T-MAX™ performs exceptionally well even without added flavours. Since most cigarette smokers do not smoke for the tobacco flavour but rather for the nicotine hit and habitual experience, T-MAX™ provides a viable alternative that aligns with new regulatory landscapes.HIGHLIGHTS// flavour bans spreading across regions/ T-MAX™ performs exceptionally well even without added flavoursEmpowering vape brands with free access to T-MAX™By granting customers royalty-free access to the T-MAX™ technology, Alchem NicSelect™ is removing barriers for vaping brands and original equipment manufacturers (OEMs) looking to adapt to regulatory changes. This open-access approach ensures that manufacturers can integrate T-MAX™ into their product lines without additional costs, allowing them to offer superior nicotine satisfaction in markets where flavours are no longer an option.HIGHLIGHTS// removing barriers for vaping brands and OEMs looking to adapt/ manufacturers can integrate T-MAX™ into product lines without additional costsThe future of vaping in restricted marketsWith T-MAX™, the vaping industry has a powerful tool to retain customers and convert smokers who have struggled with traditional vaping products. By delivering the key elements of cigarette satisfaction — without combustion or flavours — T-MAX™ is set to redefine what a satisfying vape experience means in a post-flavour-ban world.“Our commitment to innovation and accessibility means we are providing our customers with the solutions they need to navigate an evolving regulatory landscape. T-MAX™ allows brands to offer a highly satisfying experience that mimics smoking without relying on flavours. The message is clear: no flavour, but not less satisfying”, added Santambrogio.HIGHLIGHTS// powerful tool to retain customers and convert smokers/ delivering the key elements of cigarette satisfaction without combustion or flavours/ no flavour, but not less satisfying

Impressions: 274

https://www.pharmacompass.com/speak-pharma/alchem-nicselect-grants-customers-royalty-free-access-to-t-max-tech-for-3-in-1-vape-satisfaction-in-flavour-restricted-markets

Radio Compass
06 May 2025

VLOG #PharmaReel

[Sponsored by another company]
This PharmaReel highlights Transo-Pharm USA’s offerings of premium Phyto Cannabidiol (CBD) and Phyto Cannabigerol (CBG) isolates from its cGMP-certified facility inspected by the FDA and ANVISA. The company has an expanded reach across the US and EU.

Impressions: 332

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DATA COMPILATION #PharmaFlow

[Sponsored by another company]
DMF filings surge 44% in Q1 2025; India tops list with 51% rise in year-on-year submissions
The first quarter (Q1) of 2025 witnessed an impressive surge in Drug Master File (DMF) submissions to the US Food and Drug Administration (FDA), signaling a robust expansion in pharmaceutical development activities, the looming threat of tariffs notwithstanding.A total of 339 Type II DMFs were submitted during this period, as opposed to 235 submissions in Q1 2024, marking an exceptional increase of 44.26 percent. PharmaCompass’ data suggests that this is a record high for any first quarter.Overall, 440 DMFs were submitted across all categories (Types II, III, IV, and V) during Q1 2025, compared to 353 in the same period last year — representing a 24.65 percent increase.India and China continued to dominate the DMF landscape. India led with 162 submissions in Q1 2025, posting a remarkable 51.4 percent increase over 107 submissions recorded in Q1 2024. China followed with 135 submissions, representing a 33.66 percent increase over the 101 filings in Q1 2024.Taiwan sprung a surprise as a distant third. It made 12 DMF submissions in Q1 2025, as opposed to just one in Q1 2024. Western countries like the US, Spain, Germany, and Italy have maintained relatively stable or declining submission rates. Only the Netherlands showed significant growth with four DMF submissions in Q1 2025, up from zero in Q1 2024. View FDA DMF Filings in Q1 2025 (Power BI Dashboard, Free Excel Available)Indian giants MSN, Aurobindo, Cipla, Dr Reddy’s lead record-breaking DMF surgeIndia lived up to its “pharmacy of the world” reputation with the highest DMF submissions. In fact, seven of the top eight companies in the DMF tally were headquartered in India. MSN Group, emerged as the unequivocal leader with 23 submissions in Q1 2025, as against 15 in Q1 2024. Aurobindo Pharma increased its DMF activity from seven submissions in Q1 2024 to 12 in Q1 2025. Alivus Life Sciences, formerly known as Glenmark, made a dramatic leap with eight submissions in Q1 2025, quadrupling its previous year’s count of just two. Cipla more than doubled its DMF submissions — from three in Q1 2024 to eight in Q1 2025.Dr. Reddy’s Laboratories, one of India’s largest generic drugmakers, filed seven DMF submissions. The company’s Q1 2025 DMF portfolio includes high-value molecules like deucravacitinib, finerenone, enzalutamide, niraparib tosylate monohydrate, tucatinib, and tizanidine hydrochloride.Dr. Reddy’s has also indicated that they are open to manufacturing in the US. Meanwhile, Hetero Drugs filed seven submissions while Lee Pharma recorded six in Q1 2025.Chinese manufacturer Jiangsu East-Mab Biomedical Technology also established a significant presence with six DMFs. View FDA DMF Filings in Q1 2025 (Power BI Dashboard, Free Excel Available) Semaglutide, finerenone see most DMF submissions; first-time filings surge 64%Semaglutide and finerenone emerged as the most documented molecules in Q1 2025, each garnering nine DMF submissions. Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist that has revolutionized diabetes management and weight loss treatment, continues to attract significant manufacturer interest. Similarly, finerenone, a non-steroidal drug used in treating chronic kidney disease in type 2 diabetes patients, has garnered attention from manufacturers.Carfilzomib, used in multiple myeloma treatment, secured the third position with five DMF submissions. Deucravacitinib, a novel drug approved for moderate to severe plaque psoriasis, followed with four DMF submissions.There were several molecules with three DMF submissions each. Among them were tapinarof, a novel drug for psoriasis, and tirzepatide, a GLP-1/GIP receptor agonist that has shown remarkable efficacy in diabetes and weight management. During the quarter, 23 molecules received their inaugural DMF submissions. This number has risen by 64 percent since Q1 2024, when only 14 drugs saw their first DMF filings.In Q1 2025, these 23 first-time molecules collectively garnered 30 DMF submissions, with deucravacitinib emerging as the clear leader. Indian companies Dr. Reddy’s Laboratories and Cipla filed DMFs for this plaque psoriasis treatment as did Spain’s Curia and PMC Global.The Q1 2025 roster of first-time DMF filings include retatrutide (another GLP-1 receptor agonist), sotagliflozin, setmelanotide acetate, daridorexant, nusinersen, zavegepant, belzutifan, elacestrant dihydrochloride, selumetinib sulfate, sotorasib, atogepant, omadacycline tosylate, osilodrostat phosphate, ensifentrine, landiolol hydrochloride, maralixibat chloride, maribavir, methyl olivetolate, diazoxide choline, sparsentan, thinnertide, and vismodegib. View FDA DMF Filings in Q1 2025 (Power BI Dashboard, Free Excel Available) Our viewGiven Trump’s rhetoric around tariffs on imported drugs, the record-breaking DMF submissions in Q1 2025 sent out a strong message that the global pharmaceutical industry is willing to take on the complex geopolitical situation with resilience and strategic foresight.On a different note, the rise in DMF filings also indicate increased workload for the FDA staff, as also more inspections by the agency. It seems like more ‘laid off’ FDA employees will be asked to return to work in the coming days.

Impressions: 519

https://www.pharmacompass.com/radio-compass-blog/dmf-filings-surge-44-in-q1-2025-india-tops-list-with-51-rise-in-year-on-year-submissions

#PharmaFlow by PHARMACOMPASS
15 May 2025

NEWS #PharmaBuzz

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https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/weight-is-over-pharma-companies-race-to-make-weight-loss-drug-semaglutide/articleshow/120215666.cms

ECONOMICTIMES
12 Apr 2025

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218699

FDA
24 Feb 2025

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218434

FDA
24 Feb 2025

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218178

FDA
08 Jan 2025

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218152

FDA
16 Dec 2024

https://www.fiercepharma.com/pharma/patent-settlement-beigene-defends-brukinsa-msns-generic-threat-until-2037

FIERCE PHARMA
19 Nov 2024

01

Duloxetine Hydrochloride

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

American Thoracic Society
Not Confirmed
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Duloxetine Hydrochloride

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

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American Thoracic Society
Not Confirmed
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CEP/COS arrow-down JDMF arrow-down EU-WCarrow-down NDC arrow-down KDMF arrow-down VMF Others AUDIT
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02

Dutasteride

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

American Thoracic Society
Not Confirmed
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Dutasteride

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

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American Thoracic Society
Not Confirmed
USDMF arrow-down CEP/COS arrow-down JDMF arrow-down EU-WCarrow-down NDC arrow-down KDMF arrow-down VMF Others AUDIT
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03

Lacosamide

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

American Thoracic Society
Not Confirmed
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Lacosamide

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

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American Thoracic Society
Not Confirmed
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04

Oseltamivir Phosphate

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

American Thoracic Society
Not Confirmed
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Oseltamivir Phosphate

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

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American Thoracic Society
Not Confirmed
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05

Voriconazole

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

American Thoracic Society
Not Confirmed
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Voriconazole

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

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American Thoracic Society
Not Confirmed
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06

Pioglitazone Hydrochloride

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

American Thoracic Society
Not Confirmed
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Pioglitazone Hydrochloride

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

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American Thoracic Society
Not Confirmed
USDMF arrow-down CEP/COS arrow-down JDMF arrow-down EU-WCInactive-api NDC arrow-down KDMF arrow-down VMF Others AUDIT
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07

Montelukast Sodium

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

American Thoracic Society
Not Confirmed
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Montelukast Sodium

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

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American Thoracic Society
Not Confirmed
USDMF arrow-down CEP/COS arrow-down JDMF EU-WCarrow-down NDC arrow-down KDMF arrow-down VMF Others AUDIT
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08

Moxifloxacin Hydrochloride

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

American Thoracic Society
Not Confirmed
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Moxifloxacin Hydrochloride

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

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American Thoracic Society
Not Confirmed
USDMF arrow-down CEP/COS arrow-down JDMF EU-WCarrow-down NDC arrow-down KDMF arrow-down VMF Others AUDIT
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09

Pantoprazole Sodium

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

American Thoracic Society
Not Confirmed
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Pantoprazole Sodium

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

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American Thoracic Society
Not Confirmed
USDMF arrow-down CEP/COS arrow-down JDMF EU-WCarrow-down NDC arrow-down KDMF VMF Others AUDIT
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10

Rosuvastatin Calcium

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

American Thoracic Society
Not Confirmed
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Rosuvastatin Calcium

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

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American Thoracic Society
Not Confirmed
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USDMF

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02

American Thoracic Society
Not Confirmed
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05

American Thoracic Society
Not Confirmed
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American Thoracic Society
Not Confirmed

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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06

American Thoracic Society
Not Confirmed
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07

American Thoracic Society
Not Confirmed
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08

STLE Annual Meeting
Not Confirmed
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09

American Thoracic Society
Not Confirmed
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10

American Thoracic Society
Not Confirmed
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JDMF

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01

STLE Annual Meeting
Not Confirmed
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STLE Annual Meeting
Not Confirmed

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

STLE Annual Meeting
Not Confirmed
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STLE Annual Meeting
Not Confirmed

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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03

STLE Annual Meeting
Not Confirmed
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STLE Annual Meeting
Not Confirmed

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

STLE Annual Meeting
Not Confirmed
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STLE Annual Meeting
Not Confirmed

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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05

STLE Annual Meeting
Not Confirmed
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STLE Annual Meeting
Not Confirmed

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

STLE Annual Meeting
Not Confirmed
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STLE Annual Meeting
Not Confirmed

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

STLE Annual Meeting
Not Confirmed
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STLE Annual Meeting
Not Confirmed

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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08

STLE Annual Meeting
Not Confirmed
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STLE Annual Meeting
Not Confirmed

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

STLE Annual Meeting
Not Confirmed
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STLE Annual Meeting
Not Confirmed

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

STLE Annual Meeting
Not Confirmed
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STLE Annual Meeting
Not Confirmed

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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FDA Orange Book

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01

Brand Name : ABIRATERONE ACETATE

STLE Annual Meeting
Not Confirmed
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Brand Name : ABIRATERONE ACETATE

STLE Annual Meeting
Not Confirmed
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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

STLE Annual Meeting
Not Confirmed
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Brand Name : ABIRATERONE ACETATE

STLE Annual Meeting
Not Confirmed
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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 : ACYCLOVIR

STLE Annual Meeting
Not Confirmed
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Brand Name : ACYCLOVIR

STLE Annual Meeting
Not Confirmed
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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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04

Brand Name : AFATINIB

STLE Annual Meeting
Not Confirmed
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Brand Name : AFATINIB

STLE Annual Meeting
Not Confirmed
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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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Brand Name : AFATINIB

STLE Annual Meeting
Not Confirmed
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Brand Name : AFATINIB

STLE Annual Meeting
Not Confirmed
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MSN Laboratories

Dosage Form : TABLET; ORAL

Proprietary Name : AFATINIB

Dosage Strength : 30MG

Approval Date :

Application Number : 210804

RX/OTC/DISCN :

RLD :

TE Code :

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Brand Name : AFATINIB

STLE Annual Meeting
Not Confirmed
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Brand Name : AFATINIB

STLE Annual Meeting
Not Confirmed
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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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Brand Name : ALBENDAZOLE

STLE Annual Meeting
Not Confirmed
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Brand Name : ALBENDAZOLE

STLE Annual Meeting
Not Confirmed
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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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Brand Name : ALOGLIPTIN AND METFO...

American Thoracic Society
Not Confirmed
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Brand Name : ALOGLIPTIN AND METFO...

American Thoracic Society
Not Confirmed
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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 :

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09

Brand Name : ALOGLIPTIN AND METFO...

STLE Annual Meeting
Not Confirmed
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Brand Name : ALOGLIPTIN AND METFO...

STLE Annual Meeting
Not Confirmed
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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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10

Brand Name : ALOGLIPTIN

STLE Annual Meeting
Not Confirmed
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Brand Name : ALOGLIPTIN

STLE Annual Meeting
Not Confirmed
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MSN Laboratories

Dosage Form : TABLET; ORAL

Proprietary Name : ALOGLIPTIN

Dosage Strength : EQ 6.25MG BASE

Approval Date :

Application Number : 210213

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

American Thoracic Society
Not Confirmed
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Calcobutrol Sodium

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

arrow
American Thoracic Society
Not Confirmed
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Inspections and registrations

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FDA

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01

FDA Audited

USA
American Thoracic Society
Not Confirmed
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FDA Audited

USA
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American Thoracic Society
Not Confirmed

MSN Laboratories

City : Rangareddy District

State :

Country/Area : IN

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
American Thoracic Society
Not Confirmed
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FDA Audited

USA
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MSN Laboratories

City : Chandampet

State :

Country/Area : IN

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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MSN Laboratories

City : Patancheru, Medak Distric...

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Country/Area : IN

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District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2015-06-10

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MSN Laboratories

City : Medak District

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Country/Area : IN

Zip :

District : ORA

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Project Area : Drug Quality Assurance

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Inspection End Date : 2015-04-03

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MSN Laboratories

City : Medak District

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Country/Area : IN

Zip :

District : ORA

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Project Area : Drug Quality Assurance

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MSN Laboratories

City : Bollaram

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Country/Area : IN

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Inspection End Date : 2014-10-31

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MSN Laboratories

City : Patancheru, Medak Distric...

State :

Country/Area : IN

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

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MSN Laboratories

City : Nalgonda District

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Country/Area : IN

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

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American Thoracic Society
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FDA Audited

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MSN Laboratories

City : Medak District

State :

Country/Area : IN

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2012-03-09

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10

FDA Audited

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American Thoracic Society
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FDA Audited

USA
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American Thoracic Society
Not Confirmed

MSN Laboratories

City : Patancheru, Medak Distric...

State :

Country/Area : IN

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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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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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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GDUFA fees paid

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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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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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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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