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Chemistry

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Also known as: 1025967-78-5, Xiidra, Sar 1118, Sar-1118, Shp606, Shp-606
Molecular Formula
C29H24Cl2N2O7S
Molecular Weight
615.5  g/mol
InChI Key
JFOZKMSJYSPYLN-QHCPKHFHSA-N
FDA UNII
038E5L962W

Lifitegrast
Lifitegrast is a FDA approved drug for the treatment of keratoconjunctivitis sicca (dry eye syndrome). It is a tetrahydroisoquinoline derivative and lymphocyte function-associated antigen-1 ( LFA-1) antagonist that was discovered through the rational design process. The ophthalmic solution was approved in July, 2016 under the trade name Xiidra. It has shown to protect the corneal surface and alleviate the symptoms of dry eye syndrome with fast onset of action and well tolerated profile in both local and systemic setting.
Lifitegrast is a Lymphocyte Function-Associated Antigen-1 Antagonist. The mechanism of action of lifitegrast is as a Lymphocyte Function-Associated Antigen-1 Antagonist.
1 2D Structure

Lifitegrast

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S)-2-[[2-(1-benzofuran-6-carbonyl)-5,7-dichloro-3,4-dihydro-1H-isoquinoline-6-carbonyl]amino]-3-(3-methylsulfonylphenyl)propanoic acid
2.1.2 InChI
InChI=1S/C29H24Cl2N2O7S/c1-41(38,39)20-4-2-3-16(11-20)12-23(29(36)37)32-27(34)25-22(30)13-19-15-33(9-7-21(19)26(25)31)28(35)18-6-5-17-8-10-40-24(17)14-18/h2-6,8,10-11,13-14,23H,7,9,12,15H2,1H3,(H,32,34)(H,36,37)/t23-/m0/s1
2.1.3 InChI Key
JFOZKMSJYSPYLN-QHCPKHFHSA-N
2.1.4 Canonical SMILES
CS(=O)(=O)C1=CC=CC(=C1)CC(C(=O)O)NC(=O)C2=C(C=C3CN(CCC3=C2Cl)C(=O)C4=CC5=C(C=C4)C=CO5)Cl
2.1.5 Isomeric SMILES
CS(=O)(=O)C1=CC=CC(=C1)C[C@@H](C(=O)O)NC(=O)C2=C(C=C3CN(CCC3=C2Cl)C(=O)C4=CC5=C(C=C4)C=CO5)Cl
2.2 Other Identifiers
2.2.1 UNII
038E5L962W
2.3 Synonyms
2.3.1 MeSH Synonyms

1. (2s)-2-(((2-(benzofuran-6-ylcarbonyl)-5,7-dichloro-1,2,3,4-tetrahydroisoquinolin-6- Yl)carbonyl)amino)-3-(3-(methylsulfonyl)phenyl)propanoic Acid

2. L-phenylalanine, N-((2-(6-benzofuranylcarbonyl)-5,7-dichloro-1,2,3,4-tetrahydro-6-isoquinolinyl)carbonyl)-3-(methylsulfonyl)-

3. Lifitegrast Ophthalmic Solution

4. Sar 1118

5. Sar-1118

6. Shp-606

7. Shp606

8. Xiidra

2.3.2 Depositor-Supplied Synonyms

1. 1025967-78-5

2. Xiidra

3. Sar 1118

4. Sar-1118

5. Shp606

6. Shp-606

7. (s)-2-(2-(benzofuran-6-carbonyl)-5,7-dichloro-1,2,3,4-tetrahydroisoquinoline-6-carboxamido)-3-(3-(methylsulfonyl)phenyl)propanoic Acid

8. Chembl2048028

9. 038e5l962w

10. (2s)-2-(((2-(benzofuran-6-ylcarbonyl)-5,7-dichloro-1,2,3,4-tetrahydroisoquinolin-6- Yl)carbonyl)amino)-3-(3-(methylsulfonyl)phenyl)propanoic Acid

11. L-phenylalanine, N-((2-(6-benzofuranylcarbonyl)-5,7-dichloro-1,2,3,4-tetrahydro-6-isoquinolinyl)carbonyl)-3-(methylsulfonyl)-

12. L-phenylalanine, N-[[2-(6-benzofuranylcarbonyl)-5,7-dichloro-1,2,3,4-tetrahydro-6-isoquinolinyl]carbonyl]-3-(methylsulfonyl)-

13. Lifitegrast [usan:inn]

14. Unii-038e5l962w

15. Sar1118

16. Xiidra (tn)

17. Lifitegrast [mi]

18. Lifitegrast [inn]

19. Lifitegrast (usan/inn)

20. Lifitegrast [usan]

21. Lifitegrast; Sar 1118

22. Lifitegrast [who-dd]

23. Lifitegrast Ophthalmic Solution

24. Gtpl7533

25. Schembl2632068

26. Amy4450

27. Dtxsid60145345

28. Lifitegrast [orange Book]

29. Chebi:133023

30. Ex-a2582

31. Bdbm50386331

32. Mfcd28502439

33. S3714

34. Zinc84668739

35. Ccg-270245

36. Cs-6264

37. Db11611

38. Compound 1g [pmid: 24900456]

39. Ac-32534

40. Ds-20052

41. Hy-19344

42. D10374

43. A900838

44. Q23044263

45. (2s)-2-[[2-(1-benzofuran-6-carbonyl)-5,7-dichloro3,4-dihydro-1h-isoquinoline-6-carbonyl]amino]-3-(3-methylsulfonylphenyl)propanoic Acid

46. N-[[2-(6-benzofuranylcarbonyl)-5,7-dichloro-1,2,3,4-tetrahydro-6-isoquinolinyl]carbonyl]-3-(methylsulfonyl)-l-phenylalanine

47. N-[2-(1-benzofuran-6-carbonyl)-5,7-dichloro-1,2,3,4-tetrahydroisoquinoline-6-carbonyl]-3-(methanesulfonyl)-l-phenylalanine

2.4 Create Date
2006-12-18
3 Chemical and Physical Properties
Molecular Weight 615.5 g/mol
Molecular Formula C29H24Cl2N2O7S
XLogP34.7
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count7
Rotatable Bond Count7
Exact Mass614.0681277 g/mol
Monoisotopic Mass614.0681277 g/mol
Topological Polar Surface Area142 Ų
Heavy Atom Count41
Formal Charge0
Complexity1100
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

For the treatment of signs and symptoms of keratoconjunctivitis sicca (dry eye syndrome).


FDA Label


Treatment of dry eye disease


5 Pharmacology and Biochemistry
5.1 Pharmacology

Lifitegrast addresses both the symptoms and the resulting ocular surface damage by interfering with ocular inflammatory cycle. Lifitegrast is a lymphocyte functionassociated antigen-1 antagonist through direct competitive antagonism and sequentially inhibits the T-cell recruitment, activation, and proinflammatory cytokine release associated with dry eye syndrome.


5.2 MeSH Pharmacological Classification

Ophthalmic Solutions

Sterile solutions that are intended for instillation into the eye. It does not include solutions for cleaning eyeglasses or CONTACT LENS SOLUTIONS. (See all compounds classified as Ophthalmic Solutions.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
LIFITEGRAST
5.3.2 FDA UNII
038E5L962W
5.3.3 Pharmacological Classes
Lymphocyte Function-Associated Antigen-1 Antagonists [MoA]; Lymphocyte Function-Associated Antigen-1 Antagonist [EPC]
5.4 ATC Code

S - Sensory organs

S01 - Ophthalmologicals

S01X - Other ophthalmologicals

S01XA - Other ophthalmologicals

S01XA25 - Lifitegrast


5.5 Absorption, Distribution and Excretion

Absorption

The mean peak plasma concentration (Cmax) of 1.70ng/mL was reached within 15 minutes of application. Quantifiable trough plasma concentrations ranged from 0.55 ng/mL to 3.74 ng/mL. Observations show limited systemic exposure that produces significant clinical outcomes.


Route of Elimination

Not possible to perform mass balance study to determine the main route of elimination.


Clearance

Not possible to calculate clearance rate based on plasma concentrations of lifitegrast, but reported to be relatively fast in rat I.V. pharmacokinetics study. It is predicted that lifitegrast is cleared via nasal and subsequently gastrointestinal tract.


5.6 Metabolism/Metabolites

Based on the findings of an in vitro metabolism study using fresh human hepatocytes, lifitegrast does not appear to undergo significant metabolism.


5.7 Biological Half-Life

Not possible to calculate plasma elimination half-life based on plasma concentrations of lifitegrast, but reported to be relatively short in rat I.V. pharmacokinetics study.


5.8 Mechanism of Action

Lifitegrast binds to the integrin lymphocyte function-associated antigen-1 (LFA-1), a cell surface protein found on leukocytes and blocks the interaction of LFA-1 with its cognate ligand intercellular adhesion molecule-1 (ICAM-1). ICAM-1 may be overexpressed in corneal and conjunctival tissues in dry eye disease. LFA-1/ICAM-1 interaction can contribute to the formation of an immunological synapse resulting in T-cell proliferation/activation and migration to target tissues. In vitro studies demonstrated that lifitegrast may inhibit T-cell adhesion to ICAM-1 in a human T-cell line and may inhibit secretion of inflammatory cytokines, inflammatory mediators, chemokines, TNF-, and IL-1 in human peripheral blood mononuclear cells.


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24-Mar-2022
17-Sep-2025
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Europe

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01

World Health Expo
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Lifitegrastum

Brand Name : Xiidra

Dosage Form : Eye Drop

Dosage Strength : 50mg/ml

Packaging :

Approval Date : 19/12/2018

Application Number : 66850

Regulatory Info : Allowed

Registration Country : Switzerland

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Canada

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01

Arab Health
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Arab Health
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LIFITEGRAST

Brand Name : XIIDRA

Dosage Form : SOLUTION

Dosage Strength : 5%/W/V

Packaging :

Approval Date :

Application Number : 2471027

Regulatory Info : Prescription

Registration Country : Canada

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Listed Dossiers

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Pharmathen SA

Greece
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

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Digital Content Digital Content

Regulatory Info :

Registration Country : Greece

Lifitegrast

Brand Name :

Dosage Form : Ophthalmic Solution

Dosage Strength : 50MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Greece

Pharmathen

01

Pharmathen SA

Greece
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Flag Greece
Digital Content Digital Content

Packaging :

Regulatory Info :

Lifitegrast

Dosage : Ophthalmic Solution

Dosage Strength : 50MG/ML

Brand Name :

Approval Date :

Application Number :

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DATA COMPILATION #PharmaFlow

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DMF filings rise 4.5% in Q3 2025; China holds lead, India records 20% growth in submissions
The third quarter (Q3) of 2025 witnessed a steady rise in Drug Master File (DMF) submissions to the US Food and Drug Administration (FDA). DMFs are used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug productsA total of 323 Type II DMFs were submitted during this period, as opposed to 309 submissions in Q3 2024, marking an increase of 4.53 percent. This is the second highest number since 2018. In Q1 2025, 339 Type II filings were recorded.Across all DMF types (II, III, IV, and V), 479 DMFs were filed in Q3 2025, compared to 394 in Q3 2024, representing a 21.57 percent increase. Out of the 323 Type II DMFs submitted in Q3 2025, 40 had completed their review by the end of Q3, reflecting a processing lag between submission and review completion. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available)China maintains its lead while India posts double-digit growth in DMF submissions China and India continued to dominate DMF submissions in Q3 2025. China retained the top spot with 153 Type II DMFs, matching its submission count from Q3 2024. India recorded 131 DMFs, marking a 20.18 percent increase over 109 filings during the corresponding period last year.The United States stood a distant third with 17 filings, compared to 13 in Q3 2024. Among European nations, Italy recorded eight DMFs, doubling its 2024 tally. The Netherlands filed four, up from three. Spain submitted only one DMF, as against seven submitted in Q3 2024. Taiwan made three filings, up from one submitted in Q3 2024. Together, India, China and Taiwan accounted for about 88.9 percent of all Type II DMFs filed during the quarter. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) China’s Suzhou Ryway Biotech tops corporate tally; India’s Hetero, Biophore followChina’s Suzhou Ryway Biotech led the company-wise tally with 12 DMF submissions in Q3 2025. The company had not filed any DMFs in Q3 2024.India’s Hetero Group followed with nine DMFs, maintaining the same number of filings as Q3 2024. Biophore India Pharmaceuticals ranked third with six DMFs, doubling its count from three last year.Other notable contributors include Sai Sreyas Pharmaceuticals (India) and Shanghai Haoyuan Chemexpress (China), with five DMFs each. Companies such as SNJ Group, Lunan Pharmaceutical, Allsino Pharmaceutical, Shankus Pharma, Jiangxi Xinganjiang Pharmaceutical, Sunpure Extracts, Lee Pharma, Umedica Laboratories, Linhai Tianyu Pharmaceutical and Maithri Drugs filed four DMFs each. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) Olaparib, semaglutide lead molecular filings; Dr. Reddy’s files DMF for edoxaban & tucatinibDr. Reddy’s Laboratories also featured among key DMF filers in Q3 2025, submitting two DMFs — for edoxaban tosylate monohydrate and tucatinib copovidone. Edoxaban tosylate monohydrate (marketed as Savaysa by Daiichi Sankyo) is a prescription anticoagulant used to reduce the risk of stroke and to treat deep vein thrombosis and pulmonary embolism. Patent exclusivity for Savaysa extends until October 2026 in the United States, with no generic currently available.In terms of molecules, the highest number of DMFs were filed for olaparib, semaglutide, ruxolitinib phosphate, ferric carboxymaltose, and vismodegib, with three DMFs each in Q3 2025.Olaparib, sold by AstraZeneca under the brand name Lynparza, saw DMFs being filed by BDR Lifesciences and Intas Pharmaceuticals from India, and by ScinoPharm Taiwan during the quarter.Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist developed by Novo Nordisk, continued to draw strong interest from API manufacturers. DMFs for semaglutide were filed by three Chinese companies: Yangzhou Aurisco Pharmaceutical, Zhejiang Peptites Biotech, and Fujian Genohope Biotech.Ruxolitinib phosphate, marketed by Incyte as Jakafi, saw three DMFs. Three Indian companies — Alembic Pharmaceuticals, Valary Labs, and Devi Pharmatech — filed DMFs for this API in Q3 2025. Other molecules that received multiple DMF submissions include ferric carboxymaltose (used to treat iron-deficiency anemia) and vismodegib (an oral therapy for basal-cell carcinoma). View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) First-time DMF filings span 17 companies; India leads with nine first-time DMFs The quarter saw first-time DMF filings from 17 companies. India took a lead here with nine first-time DMF filings, followed by China (six), and the US (two).The DMF filings in this quarter included inclisiran sodium (filed by Aurisco Pharmaceutical of China), pacritinib citrate (by TAPI Nl B.V. of the Netherlands), and vosoritide (by Apicore LLC of the US).Out of the 19 first-time DMFs filed in Q3 2025, four completed their Generic Drug User Fee Amendments (GDUFA) review process during the quarter. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) GDUFA fee for FY 2026: The FDA Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry.Fee rates for fiscal year 2026 were published on July 30, 2025. FDA has revised fees under GDUFA III across all categories. While there is a slight increase in the DMF fee from US$ 95,084 in 2025 to US$ 102,584 in 2026, the ANDA fee has seen a sharp rise: from US$ 321,920 in 2025 to US$ 358,247 in 2026.FY 2025 and FY 2026 User Fee Rates Generic drug fee category Fees rates for FY 2025 Fees rates for FY 2026 Applications:     Abbreviated New Drug Application (ANDA) US$ 3,21,920 US$ 3,58,247 Drug Master File (DMF) US$ 95,084 US$ 1,02,584 Facilities:     Active Pharmaceutical Ingredient (API)—Domestic US$ 41,580 US$ 43,549 API—Foreign US$ 56,580 US$ 58,549 Finished Dosage Form (FDF)—Domestic US$ 2,31,952 US$ 2,38,943 FDF—Foreign US$ 2,46,952 US$ 2,53,943 Contract Manufacturing Organization (CMO)—Domestic US$ 55,668 US$ 57,346 CMO—Foreign US$ 70,668 US$ 72,346 GDUFA Program:     Large size operation generic drug applicant US$ 18,91,664 US$ 19,18,377 Medium size operation generic drug applicant US$ 7,56,666 US$ 7,67,351 Small business generic drug applicant US$ 1,89,166 US$ 1,91,838 Our viewFor several years prior to the pandemic, India had a lead in Type II DMF submissions. In recent years, China has surpassed India in DMF filings. But Q3 2025 numbers indicate that Indian drugmakers are fast catching up. Since DMFs establish trust in APIs from across the world, we feel this healthy competition between drugmakers from the two countries is good for the global pharmaceutical industry. 

Impressions: 3328

https://www.pharmacompass.com/radio-compass-blog/dmf-filings-rise-4-5-in-q3-2025-china-holds-lead-india-records-20-growth-in-submissions

#PharmaFlow by PHARMACOMPASS
13 Nov 2025

NEWS #PharmaBuzz

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https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215058

FDA
04 Jun 2024

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215063

FDA
07 Nov 2023

https://www.businesswire.com/news/home/20230823071188/en

BUSINESSWIRE
24 Aug 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215081

FDA
04 Aug 2023

https://www.reuters.com/markets/deals/bausch-lomb-buy-dry-eye-drug-novartis-175-billion-wsj-2023-06-30/

REUTERS
01 Jul 2023
Novartis targets Xiidra in eye disease asset sale
Novartis targets Xiidra in eye disease asset sale

14 Mar 2023

// Angus Liu FIERCE PHARMA

https://www.fiercepharma.com/pharma/after-34b-deal-and-eu-withdrawal-novartis-wants-xiidra-gone-sale-some-eye-meds-bloomberg

Angus Liu FIERCE PHARMA
14 Mar 2023

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ABOUT THIS PAGE

Looking for 1025967-78-5 / Lifitegrast API manufacturers, exporters & distributors?

Lifitegrast manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Lifitegrast API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Lifitegrast manufacturer or Lifitegrast supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lifitegrast manufacturer or Lifitegrast supplier.

PharmaCompass also assists you with knowing the Lifitegrast API Price utilized in the formulation of products. Lifitegrast API Price is not always fixed or binding as the Lifitegrast Price is obtained through a variety of data sources. The Lifitegrast Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Lifitegrast

Synonyms

1025967-78-5, Xiidra, Sar 1118, Sar-1118, Shp606, Shp-606

Cas Number

1025967-78-5

Unique Ingredient Identifier (UNII)

038E5L962W

About Lifitegrast

Lifitegrast is a FDA approved drug for the treatment of keratoconjunctivitis sicca (dry eye syndrome). It is a tetrahydroisoquinoline derivative and lymphocyte function-associated antigen-1 ( LFA-1) antagonist that was discovered through the rational design process. The ophthalmic solution was approved in July, 2016 under the trade name Xiidra. It has shown to protect the corneal surface and alleviate the symptoms of dry eye syndrome with fast onset of action and well tolerated profile in both local and systemic setting.

1025967-78-5 Manufacturers

A 1025967-78-5 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1025967-78-5, including repackagers and relabelers. The FDA regulates 1025967-78-5 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1025967-78-5 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of 1025967-78-5 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

1025967-78-5 Suppliers

A 1025967-78-5 supplier is an individual or a company that provides 1025967-78-5 active pharmaceutical ingredient (API) or 1025967-78-5 finished formulations upon request. The 1025967-78-5 suppliers may include 1025967-78-5 API manufacturers, exporters, distributors and traders.

click here to find a list of 1025967-78-5 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

1025967-78-5 USDMF

A 1025967-78-5 DMF (Drug Master File) is a document detailing the whole manufacturing process of 1025967-78-5 active pharmaceutical ingredient (API) in detail. Different forms of 1025967-78-5 DMFs exist exist since differing nations have different regulations, such as 1025967-78-5 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A 1025967-78-5 DMF submitted to regulatory agencies in the US is known as a USDMF. 1025967-78-5 USDMF includes data on 1025967-78-5's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 1025967-78-5 USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of 1025967-78-5 suppliers with USDMF on PharmaCompass.

1025967-78-5 KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a 1025967-78-5 Drug Master File in Korea (1025967-78-5 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 1025967-78-5. The MFDS reviews the 1025967-78-5 KDMF as part of the drug registration process and uses the information provided in the 1025967-78-5 KDMF to evaluate the safety and efficacy of the drug.

After submitting a 1025967-78-5 KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their 1025967-78-5 API can apply through the Korea Drug Master File (KDMF).

click here to find a list of 1025967-78-5 suppliers with KDMF on PharmaCompass.

1025967-78-5 WC

A 1025967-78-5 written confirmation (1025967-78-5 WC) is an official document issued by a regulatory agency to a 1025967-78-5 manufacturer, verifying that the manufacturing facility of a 1025967-78-5 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 1025967-78-5 APIs or 1025967-78-5 finished pharmaceutical products to another nation, regulatory agencies frequently require a 1025967-78-5 WC (written confirmation) as part of the regulatory process.

click here to find a list of 1025967-78-5 suppliers with Written Confirmation (WC) on PharmaCompass.

1025967-78-5 NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing 1025967-78-5 as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for 1025967-78-5 API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture 1025967-78-5 as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain 1025967-78-5 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 1025967-78-5 NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of 1025967-78-5 suppliers with NDC on PharmaCompass.

1025967-78-5 GMP

1025967-78-5 Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of 1025967-78-5 GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right 1025967-78-5 GMP manufacturer or 1025967-78-5 GMP API supplier for your needs.

1025967-78-5 CoA

A 1025967-78-5 CoA (Certificate of Analysis) is a formal document that attests to 1025967-78-5's compliance with 1025967-78-5 specifications and serves as a tool for batch-level quality control.

1025967-78-5 CoA mostly includes findings from lab analyses of a specific batch. For each 1025967-78-5 CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

1025967-78-5 may be tested according to a variety of international standards, such as European Pharmacopoeia (1025967-78-5 EP), 1025967-78-5 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (1025967-78-5 USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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