menu
    • menu

    Find Lorlatinib manufacturers, exporters & distributors on PharmaCompass

    Suanfarma, at the Core of a Better Life.

    Virtual Booth

    Contact Supplier

    Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

    Virtual Booth

    Contact Supplier

    Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

    Virtual Booth

    Contact Supplier

    Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

    Virtual Booth

    Contact Supplier

    Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

    Virtual Booth

    Contact Supplier

    xyz-pharma-m-2025-01-20

    Virtual Booth

    Contact Supplier

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    FINISHED DOSAGE FORMULATIONS

    DIGITAL CONTENT

    GLOBAL SALES INFORMATION

    PATENTS & EXCLUSIVITIES

    PharmaCompass

    Synopsis

    Related ProductsRelated Products

    Synopsis

    ACTIVE PHARMA INGREDIENTS

    4

    API Suppliers

    API Suppliers

    0

    USDMF

    US DMFs Filed

    0

    CEP/COS

    CEP/COS Certifications

    0

    JDMF

    JDMFs Filed

    0

    EU WC

    EU WC

    0

    KDMF

    KDMF

    0

    NDC API

    NDC API

    0

    VMF

    NDC API

    4

    Listed Suppliers

    Other Suppliers

    API REF. PRICE (USD/KG)

    $
    $ 21,746

    MARKET PLACE

    0

    API

    0

    FDF

    0INTERMEDIATES

    FINISHED DOSAGE FORMULATIONS

    8

    FDF Dossiers

    FDF Dossiers

    2

    FDA Orange Book

    FDA (Orange Book)

    2

    Europe

    Europe

    2

    Canada

    Canada

    2

    Australia

    Australia

    0

    South Africa

    South Africa

    0

    Listed Dossiers

    Listed Dossiers

    4DRUGS IN DEVELOPMENT

    FDF Dossiers

    DRUG PRODUCT COMPOSITIONS

    REF. STANDARDS OR IMPURITIES

    0

    EDQM

    0

    USP

    0

    JP

    0

    Others

    PATENTS & EXCLUSIVITIES

    10

    US Patents

    10

    US Exclusivities

    0

    Health Canada Patents

    DIGITAL CONTENT

    0

    Data Compilation #PharmaFlow

    0

    Stock Recap #PipelineProspector

    0

    Weekly News Recap #Phispers

    30

    News #PharmaBuzz

    GLOBAL SALES INFORMATION

    US Medicaid

    61,934,706

    Annual Reports

    1,352

    Finished Drug Prices

    Listed Dossiers

    0RELATED EXCIPIENT COMPANIES

    0EXCIPIENTS BY APPLICATIONS

    Chemistry

    Click the arrow to open the dropdown
    read-moreClick the button for full data set
    read-moreClick the button for full data set
    Also known as: 1454846-35-5, Pf-06463922, Loratinib, Lorbrena, Pf06463922, Pf 06463922
    Molecular Formula
    C21H19FN6O2
    Molecular Weight
    406.4  g/mol
    InChI Key
    IIXWYSCJSQVBQM-LLVKDONJSA-N
    FDA UNII
    OSP71S83EU
    Lorlatinib
    Lorlatinib is an orally available, ATP-competitive inhibitor of the receptor tyrosine kinases, anaplastic lymphoma kinase (ALK) and C-ros oncogene 1 (Ros1), with potential antineoplastic activity. Upon administration, lorlatinib binds to and inhibits both ALK and ROS1 kinases. The kinase inhibition leads to disruption of ALK- and ROS1-mediated signaling and eventually inhibits tumor cell growth in ALK- and ROS1-overexpressing tumor cells. In addition, PF-06463922 is able to cross the blood brain barrier. ALK belongs to the insulin receptor superfamily and plays an important role in nervous system development; ALK dysregulation and gene rearrangements are associated with a series of tumors. ROS1, overexpressed in certain cancer cells, plays a key role in cell growth and survival of cancer cells.
    Lorlatinib is a Kinase Inhibitor. The mechanism of action of lorlatinib is as a Kinase Inhibitor, and Cytochrome P450 3A Inducer, and P-Glycoprotein Inducer, and Cytochrome P450 2B6 Inducer, and Organic Cation Transporter 1 Inhibitor, and Organic Anion Transporter 3 Inhibitor, and Multidrug and Toxin Extrusion Transporter 1 Inhibitor, and Breast Cancer Resistance Protein Inhibitor.
    1 2D Structure

    Lorlatinib

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (16R)-19-amino-13-fluoro-4,8,16-trimethyl-9-oxo-17-oxa-4,5,8,20-tetrazatetracyclo[16.3.1.02,6.010,15]docosa-1(22),2,5,10(15),11,13,18,20-octaene-3-carbonitrile
    2.1.2 InChI
    InChI=1S/C21H19FN6O2/c1-11-15-7-13(22)4-5-14(15)21(29)27(2)10-16-19(17(8-23)28(3)26-16)12-6-18(30-11)20(24)25-9-12/h4-7,9,11H,10H2,1-3H3,(H2,24,25)/t11-/m1/s1
    2.1.3 InChI Key
    IIXWYSCJSQVBQM-LLVKDONJSA-N
    2.1.4 Canonical SMILES
    CC1C2=C(C=CC(=C2)F)C(=O)N(CC3=NN(C(=C3C4=CC(=C(N=C4)N)O1)C#N)C)C
    2.1.5 Isomeric SMILES
    C[C@@H]1C2=C(C=CC(=C2)F)C(=O)N(CC3=NN(C(=C3C4=CC(=C(N=C4)N)O1)C#N)C)C
    2.2 Other Identifiers
    2.2.1 UNII
    OSP71S83EU
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. (10r)-7-amino-12-fluoro-2,10,16-trimethyl-15-oxo-10,15,16,17-tetrahydro-2h-8,4-(metheno)pyrazolo(4,3-h)(2,5,11)benzoxadiazacyclotetradecine-3-carbonitrile

    2. 7-amino-12-fluoro-2,10,16-trimethyl-15-oxo-10,15,16,17-tetrahydro-2h-8,4-(metheno)pyrazolo(4,3-h)(2,5,11)benzoxadiazacyclotetradecine-3-carbonitrile

    3. Loratinib

    4. Lorbrena

    5. Pf-06463922

    6. Pf06463922

    2.3.2 Depositor-Supplied Synonyms

    1. 1454846-35-5

    2. Pf-06463922

    3. Loratinib

    4. Lorbrena

    5. Pf06463922

    6. Pf 06463922

    7. Osp71s83eu

    8. Chembl3286830

    9. C21h19fn6o2

    10. (10r)-7-amino-12-fluoro-10,15,16,17-tetrahydro-2,10,16-trimethyl-15-oxo-2h-4,8-methenopyrazolo[4,3-h][2,5,11]benzoxadiazacyclotetradecine-3-carbonitrile

    11. (16r)-19-amino-13-fluoro-4,8,16-trimethyl-9-oxo-17-oxa-4,5,8,20-tetrazatetracyclo[16.3.1.02,6.010,15]docosa-1(22),2,5,10(15),11,13,18,20-octaene-3-carbonitrile

    12. 2h-4,8-methenopyrazolo(4,3-h)(2,5,11)benzoxadiazacyclotetradecine-3-carbonitrile, 7-amino-12-fluoro-10,15,16,17-tetrahydro-2,10,16-trimethyl-15-oxo-, (10r)-

    13. Lorviqua

    14. Mfcd28144520

    15. (10r)-7-amino-12-fluoro-2,10,16-trimethyl-15-oxo-10,15,16,17-tetrahydro-2h-8,4-(metheno)pyrazolo[4,3-h][2,5,11]benzoxadiazacyclotetradecine-3-carbonitrile

    16. Unii-osp71s83eu

    17. Lorlatinibum

    18. Lorlatinib,pf-06463922

    19. Pf-6463922

    20. 4cli

    21. 4clj

    22. Lorbrena (tn)

    23. 2h-4,8-methenopyrazolo[4,3-h][2,5,11]benzoxadiazacyclotetradecine-3-carbonitrile, 7-amino-12-fluoro-10,15,16,17-tetrahydro-2,10,16-trimethyl-15-oxo-, (10r)-

    24. Lorlatinib [mi]

    25. Lorlatinib [inn]

    26. Lorlatinib [jan]

    27. Lorlatinib [usan:inn]

    28. Lorlatinib [usan]

    29. Pfe-pkis 10

    30. Lorlatinib [who-dd]

    31. 7-amino-12-fluoro-2,10,16-trimethyl-15-oxo-10,15,16,17-tetrahydro-2h-8,4-(metheno)pyrazolo(4,3-h)(2,5,11)benzoxadiazacyclotetradecine-3-carbonitrile

    32. Lorlatinib (jan/usan/inn)

    33. Pf06463922(lorlatinib)

    34. Gtpl7476

    35. Lorlatinib [orange Book]

    36. Pf-06463922 Lorlatinib

    37. Schembl15261807

    38. Amy3295

    39. Ex-a828

    40. Chebi:143117

    41. Dtxsid201027944

    42. Bcp10287

    43. Bdbm50018830

    44. Nsc780108

    45. Nsc800990

    46. S7536

    47. Zinc98208524

    48. Akos027250753

    49. Ccg-268718

    50. Cs-3983

    51. Db12130

    52. Nsc-780108

    53. Nsc-800990

    54. Ncgc00386417-02

    55. Ncgc00386417-13

    56. Ac-30881

    57. Hy-12215

    58. A14207

    59. D11012

    60. A857523

    61. J-690185

    62. Q27285820

    63. (10r)-7-amino-12-fluoro-2,10,16-trimethyl-15-oxo-10,15,16,17-tetrahydro-2h-4,8- Methenopyrazolo(4,3-h)(2,5,11)benzoxadiazacyclotetradecine-3-carbonitrile

    64. (10r)-7-amino-12-fluoro-2,10,16-trimethyl-15-oxo-10,15,16,17-tetrahydro-2h-4,8-methenopyrazolo[4,3-h][2,5,11]benzoxadiazacyclotetradecine-3-carbonitrile

    65. (r)-26-amino-55-fluoro-11,4,7-trimethyl-6-oxo-11h-3-oxa-7-aza-2(3,5)-pyridina-1(4,3)-pyrazola-5(1,2)-benzenacyclooctaphane-15-carbonitrile

    2.4 Create Date
    2013-10-17
    3 Chemical and Physical Properties
    Molecular Weight 406.4 g/mol
    Molecular Formula C21H19FN6O2
    XLogP31.5
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count7
    Rotatable Bond Count0
    Exact Mass406.15535203 g/mol
    Monoisotopic Mass406.15535203 g/mol
    Topological Polar Surface Area110 Ų
    Heavy Atom Count30
    Formal Charge0
    Complexity700
    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

    Lorlatinib is a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) indicated for the treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on a) the prior use of crizotinib and at least one other ALK inhibitor for metastatic disease, or b) the prior use of alectinib as the first ALK inhibitor therapy for metastatic disease, or c) the prior use of certinib as the first ALK inhibitor therapy for metastatic disease.

    FDA Label

    Lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)positive advanced nonsmall cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.

    Lorviqua as monotherapy is indicated for the treatment of adult patients with ALKpositive advanced NSCLC whose disease has progressed after:

    - alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; or

    - crizotinib and at least one other ALK TKI.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Based on data from Study B7461001, exposure-response relationships for Grade 3 or 4 hypercholesterolemia and for any Grade 3 or 4 adverse reaction were observed at steady-state exposures achieved at the recommended dosage, with higher probability of the occurrence of adverse reactions with increasing lorlatinib exposure. In 295 patients who received lorlatinib at the recommended dosage of 100 mg once daily and had an ECG measurement in the same Study B7461001, the maximum mean change from baseline for their PR interval was 16.4 ms (2-sided 90% upper confidence interval [CI] 19.4 ms). Among the 284 patients with PR interval <200 ms at baseline, 14% had PR interval prolongation 200 ms after starting use with lorlatinib. The prolongation of PR interval occurred in a concentration-dependent manner and atrioventricular block occurred in 1% of patients. Finally, in 275 patients who received lorlatinib at the recommended dosage in the activity-estimating portion of Study B7461001, no large mean increases from baseline in the QTcF interval (i.e., >20 ms) were detected.

    5.2 FDA Pharmacological Classification
    5.2.1 Active Moiety
    LORLATINIB
    5.2.2 FDA UNII
    OSP71S83EU
    5.2.3 Pharmacological Classes
    Kinase Inhibitor [EPC]; Kinase Inhibitors [MoA]; Cytochrome P450 3A4 Inducers [MoA]
    5.3 ATC Code

    L01ED05

    L - Antineoplastic and immunomodulating agents

    L01 - Antineoplastic agents

    L01E - Protein kinase inhibitors

    L01ED - Anaplastic lymphoma kinase (alk) inhibitors

    L01ED05 - Lorlatinib

    5.4 Absorption, Distribution and Excretion

    Absorption

    The median lorlatinib Tmax was 1.2 hours (0.5 to 4 hours) following a single oral 100 mg dose and 2 hours (0.5 to 23 hours) following 100 mg orally once daily at steady state. The mean absolute bioavailability is 81% (90% CI 75.7%, 86.2%) after oral administration compared to intravenous administration. Administration of lorlatinib with a high fat, high-calorie meal (approximately 1000 calories with 150 calories from protein, 250 calories from carbohydrate, and 500 to 600 calories from fat) had no clinically meaningful effect on lorlatinib pharmacokinetics.

    Route of Elimination

    Following a single oral 100 mg dose of radiolabeled lorlatinib, 48% of the radioactivity was recovered in urine (<1% as unchanged) and 41% in feces (about 9% as unchanged).

    Volume of Distribution

    The mean (CV%) steady-state volume of distribution (Vss) was 305 L (28%) following a single intravenous dose.

    Clearance

    The mean oral clearance (CL/F) was 11 L/h (35%) following a single oral 100 mg dose and increased to 18 L/h (39%) at steady state, suggesting autoinduction.

    5.5 Metabolism/Metabolites

    In vitro, lorlatinib is metabolized primarily by CYP3A4 and UGT1A4, with minor contribution from CYP2C8, CYP2C19, CYP3A5, and UGT1A3. In plasma, a benzoic acid metabolite (M8) of lorlatinib resulting from the oxidative cleavage of the amide and aromatic ether bonds of lorlatinib accounted for 21% of the circulating radioactivity in a human [14C] mass balance study. The oxidative cleavage metabolite, M8, is pharmacologically inactive.

    5.6 Biological Half-Life

    The mean plasma half-life (t) of lorlatinib was 24 hours (40%) after a single oral 100 mg dose of lorlatinib.

    5.7 Mechanism of Action

    Non-small cell lung cancer (NSCLC) accounts for up to 85% of lung cancer cases worldwide and remains a particularly difficult to treat condition. The gene rearrangement of anaplastic lymphoma kinase (ALK) is a genetic alteration that drives the development of NSCLC in a number of patients. Ordinarily, ALK is a natural endogenous tyrosine kinase receptor that plays an important role in the development of the brain and elicits activity on various specific neurons in the nervous system. Subsequnetly, lorlatinib is a kinase inhibitor with in vitro activity against ALK and number of other tyrosine kinase receptor related targets including ROS1, TYK1, FER, FPS, TRKA, TRKB, TRKC, FAK, FAK2, and ACK. Lorlatinib demonstrated in vitro activity against multiple mutant forms of the ALK enzyme, including some mutations detected in tumors at the time of disease progression on crizotinib and other ALK inhibitors. Moreover, lorlatinib possesses the capability to cross the blood-brain barrier, allowing it to reach and treat progressive or worsening brain metastases as well. The overall antitumor activity of lorlatinib in in-vivo models appears to be dose-dependent and correlated with the inhibition of ALK phosphorylation. Although many ALK-positive metastatic NSCLC patients respond to initial tyrosine kinase therapies, such patients also often experience tumor progression. Various clinical trials performed with lorlatinib, however, have demonstrated its utility to effect tumor regression in ALK-positive metastatic NSCLC patients who experience tumor progression despite current use or having already used various first and second-generation tyrosine kinase inhibitors like crizotinib, alectinib, or ceritinib.

    API SUPPLIERS

    read-more
    read-more

    01

    Medichem S.A

    Spain

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

    arrow
    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Contact Supplier Contact Supplier
    Flag Spain
    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    Medichem

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    02

    TAPI Technology & API Services

    Israel

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

    arrow
    DCAT Week
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothTAPI offers customized CDMO Solutions for API development and manufacturing services.

    Contact Supplier Contact Supplier
    Flag Israel
    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    TAPI Company Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    03

    Shanghai Hope Chem

    China

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

    PharmaVenue
    Not Confirmed
    arrow

    04

    Beijing Sjar Technology Developmen...

    China

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

    PharmaVenue
    Not Confirmed
    arrow
    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    Listed Suppliers

    read-more
    read-more

    01

    Medichem S.A

    Spain
    arrow
    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Contact Supplier Contact Supplier
    Flag Spain
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Lorlatinib

    About the Company : Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Act...

    Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Active Pharmaceutical Ingredients (APIs), including Highly Potent. In 2016, Medichem merged with Combino Pharm, which is devoted to the development and manufacture (licensing) of Finished Dosage Forms. With this merger, Medichem has become a vertically integrated pharmaceutical company which can offer a complete range of products and services for the pharmaceutical industry with the highest standards of quality, operational excellence and environment respect.
    Medichem

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    02

    TAPI Technology & API Services

    Israel
    arrow
    DCAT Week
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothTAPI offers customized CDMO Solutions for API development and manufacturing services.

    Contact Supplier Contact Supplier
    Flag Israel
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Lorlatinib

    About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...

    Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, driving progress in the pharmaceutical industry. Leveraging our extensive experience and world-class expertise, we deliver one of the most comprehensive API portfolios in the industry with over 350 Products portfolio. Additionally, we provide tailored CDMO services, harnessing our proficiency in diverse technologies to meet our partners' unique needs, ensuring flexibility and excellence in every project.
    TAPI Company Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    03

    Beijing Sjar Technology Development

    China
    PharmaVenue
    Not Confirmed
    arrow

    Beijing Sjar Technology Development

    China
    arrow
    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    Post an Enquiry Post an Enquiry
    Flag China
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Lorlatinib

    About the Company : Beijing Sjar Technology Development Co., Ltd. founded in 2014, it is a high-tech enterprise which specialized in the research and development of active pharmaceutical ingredients a...

    Beijing Sjar Technology Development Co., Ltd. founded in 2014, it is a high-tech enterprise which specialized in the research and development of active pharmaceutical ingredients and their intermediates, electronic chemical materials and intermediates, large-scale production, sales and services, and provide customized synthetic services according to customer requirements. Sjar-Tech locates in Beijing Economic and Technological Development Zone, has its own R&D and development laboratory. Sjar-Tech has set up a R&D team with rich experience and strong technical strength, most of the practitioners have more than ten years' experience.
    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    04

    Shanghai Hope Chem

    China
    PharmaVenue
    Not Confirmed
    arrow

    Shanghai Hope Chem

    China
    arrow
    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    Post an Enquiry Post an Enquiry
    Flag China
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Lorlatinib

    About the Company : Hope Chem is dedicated to manufacturing, marketing, and CMO service of Active Pharmaceutical Ingredients (APIs), Intermediates, and Specialty Chemicals since the year 2010. Current...

    Hope Chem is dedicated to manufacturing, marketing, and CMO service of Active Pharmaceutical Ingredients (APIs), Intermediates, and Specialty Chemicals since the year 2010. Currently, they have exclusive partnerships with multiple, state-of-the-art and GMP-compliant manufacturers in China and abroad to service our esteemed partners for competitive, long-term & stable supplies. The main products are APIs and intermediates of antiviral drug substances and anti-inflammatory, analgesic, and non-steroidal pharmaceuticals.
    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    Digital Content read-more

    Create Content with PharmaCompass, ask us

    NEWS #PharmaBuzz

    read-more
    read-more

    Global Sales Information

    Do you need Business Intel? Ask us

    Patents & EXCLUSIVITIES

    Check the patents & exclusivity for this product

    ABOUT THIS PAGE

    Lorlatinib Manufacturers

    A Lorlatinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lorlatinib, including repackagers and relabelers. The FDA regulates Lorlatinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lorlatinib 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 Lorlatinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Lorlatinib Suppliers

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

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

    Lorlatinib GMP

    Lorlatinib 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 Lorlatinib 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 Lorlatinib GMP manufacturer or Lorlatinib GMP API supplier for your needs.

    Lorlatinib CoA

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

    Lorlatinib CoA mostly includes findings from lab analyses of a specific batch. For each Lorlatinib 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.

    Lorlatinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Lorlatinib EP), Lorlatinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lorlatinib 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.
    Ask Us for Pharmaceutical Supplier and Partner
    Ask Us, Find A Supplier / Partner
    No Commissions, No Strings Attached, Get Connected for FREE

    What are you looking for?

    How can we help you?

    The request can't be empty

    Please read our Privacy Policy carefully

    You must agree to the privacy policy

    The name can't be empty
    The company can't be empty.
    The email can't be empty Please enter a valid email.
    The mobile can't be empty

    Market Place

    Market Place

    PharmaCompass

    Home

    Market Place

    Menu

    Post Enquiry

    Post Enquiry

    Market Place

    Market Place

    Search