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Ritlecitinib

Metrochem Ritlecitinib

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ACTIVE PHARMA INGREDIENTS

11 API Suppliers, 11 Listed Suppliers, $ API Reference Price

11 API Suppliers
11 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

1 FDF Dossiers, 1 FDA Orange Book

1 FDF Dossiers
1 FDA Orange Book

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 5 NEWS #PharmaBuzz

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MARKET PLACE

1 APIs

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PATENTS & EXCLUSIVITIES

3 US Patents, 1 US Exclusivities

patents
3 US Patents
1 US Exclusivities

Metrochem Ritlecitinib

Synopsis

ACTIVE PHARMA INGREDIENTS

11

API Suppliers

0

USDMF

0

CEP/COS

CEP/COS Certifications

0

JDMF

0

EU WC

0

KDMF

0

NDC API

0

VMF

11

Listed Suppliers

API REF. PRICE (USD/KG)

$

$ 367,105

MARKET PLACE

1

API

0

FDF

1INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

1

FDF Dossiers

1

FDA Orange Book

FDA (Orange Book)

0

Europe

0

Canada

0

Australia

0

South Africa

0

Listed Dossiers

6DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

0

EDQM

0

USP

0

JP

0

Others

PATENTS & EXCLUSIVITIES

3

US Patents

1

US Exclusivities

0

Health Canada Patents

DIGITAL CONTENT

2

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GLOBAL SALES INFORMATION

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Chemistry

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Also known as: 1792180-81-4, Pf-06651600, Ritlecitinib, 1-((2s,5r)-5-((7h-pyrrolo[2,3-d]pyrimidin-4-yl)amino)-2-methylpiperidin-1-yl)prop-2-en-1-one, 2oye00pc25, Pf-06651600 free base

Molecular Formula

C₁₅H₁₉N₅O

Molecular Weight

285.34 g/mol

InChI Key

CBRJPFGIXUFMTM-WDEREUQCSA-N

FDA UNII

2OYE00PC25

Ritlecitinib

Ritlecitinib is an orally available small-molecule inhibitor of tyrosine-protein kinase JAK3 (Janus kinase 3; JAK3) with potential immunomodulatory and anti-inflammatory activities. Upon administration, ritlecitinib selectively and irreversibly binds to JAK3 and prevents the activation of the JAK-signal transducers and activators of transcription (STAT) signaling pathway. This may decrease the production of certain pro-inflammatory cytokines and prevent both an inflammatory response and the inflammation-induced damage caused by certain immunological diseases. By selectively targeting JAK3, PF-06651600 may spare interleukin (IL)-6 signaling, as well as other JAK1-dependent immunoregulatory cytokines such as IL-10, IL-27, and IL-35, which may offer a safety benefit compared to non-selective JAK inhibitors. JAK kinases are intracellular enzymes involved in signaling pathways affecting hematopoiesis, immunity and inflammation.

1 2D Structure

Ritlecitinib

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

1-[(2S,5R)-2-methyl-5-(7H-pyrrolo[2,3-d]pyrimidin-4-ylamino)piperidin-1-yl]prop-2-en-1-one

2.1.2 InChI

InChI=1S/C15H19N5O/c1-3-13(21)20-8-11(5-4-10(20)2)19-15-12-6-7-16-14(12)17-9-18-15/h3,6-7,9-11H,1,4-5,8H2,2H3,(H2,16,17,18,19)/t10-,11+/m0/s1

2.1.3 InChI Key

CBRJPFGIXUFMTM-WDEREUQCSA-N

2.1.4 Canonical SMILES

CC1CCC(CN1C(=O)C=C)NC2=NC=NC3=C2C=CN3

2.1.5 Isomeric SMILES

C[C@H]1CC[C@H](CN1C(=O)C=C)NC2=NC=NC3=C2C=CN3

2.2 Other Identifiers

2.2.1 UNII

2OYE00PC25

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 1-(5-((7h-pyrrolo(2,3-d)pyrimidin-4-yl)amino)-2-methylpiperidin-1-yl)prop-2-en-1-one

2. Pf-06651600

2.3.2 Depositor-Supplied Synonyms

1. 1792180-81-4

2. Pf-06651600

3. Ritlecitinib

4. 1-((2s,5r)-5-((7h-pyrrolo[2,3-d]pyrimidin-4-yl)amino)-2-methylpiperidin-1-yl)prop-2-en-1-one

5. 2oye00pc25

6. Pf-06651600 Free Base

7. 1-[(2s,5r)-2-methyl-5-(7h-pyrrolo[2,3-d]pyrimidin-4-ylamino)piperidin-1-yl]prop-2-en-1-one

8. Pf06651600

9. Pf 06651600

10. Ritlecitinib?

11. 2-propen-1-one, 1-((2s,5r)-2-methyl-5-(7h-pyrrolo(2,3-d)pyrimidin-4-ylamino)-1-piperidinyl)-

12. Ritlecitinib [inn]

13. Unii-2oye00pc25

14. Ritlecitinib [who-dd]

15. Gtpl9559

16. Chembl4085457

17. Schembl16764638

18. Bcp24778

19. Ex-a2613

20. Example 5 [wo2015083028]

21. Zinc526061581

22. Ccg-267324

23. Db14924

24. Compound 11 [pmid: 28139931]

25. Ac-35550

26. Bp168506

27. Hy-100754

28. Cs-0020243

29. S8538

30. C91239

31. Pf06651600;pf 06651600

2.4 Create Date

2016-02-23

3 Chemical and Physical Properties

Molecular Formula	C₁₅H₁₉N₅O
Molecular Weight	285.34 g/mol
XLogP3	2.1
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	4
Rotatable Bond Count	3
Exact Mass	285.15896025 g/mol
Monoisotopic Mass	285.15896025 g/mol
Topological Polar Surface Area	73.9 Å²
Heavy Atom Count	21
Formal Charge	0
Complexity	402
Isotope Atom Count	0
Defined Atom Stereocenter Count	2
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Indication

Treatment of alopecia areata

API SUPPLIERS

01

Metrochem API Private Limited

India

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

Pharma, Lab & Chemical Expo

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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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India

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02

Dr. Reddy's Laboratories

India

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

CPhI WW Frankfurt

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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India

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03

Chongqing Sintaho Pharmaceutical

China

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

Pharma, Lab & Chemical Expo

Not Confirmed

Chongqing Sintaho Pharma: A trusted partner globally for chemosynthetic APIs.

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China

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Chongqing Sintaho Pharmaceutical

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Digital Content

Corporate PDF

04

Jinan Tantu Chemicals

China

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

Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.

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China

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Jinan Tantu Chemicals

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05

Shandong Loncom Pharmaceutical

China

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

Pharma, Lab & Chemical Expo

Not Confirmed

Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.

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China

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06

TAPI Technology & API Services

Israel

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

CPhI WW Frankfurt

TAPI offers customized CDMO Solutions for API development and manufacturing services.

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Israel

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07

Hebi Xinhe Pharmaceutical

China

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

Pharma, Lab & Chemical Expo

Not Confirmed

08

Zhejiang Tianyu Pharmaceutical Co....

China

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

Pharma, Lab & Chemical Expo

Not Confirmed

09

Shanghai Hope Chem

China

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

Pharma, Lab & Chemical Expo

Not Confirmed

10

Micro Labs Limited

India

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

Pharma, Lab & Chemical Expo

Not Confirmed

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Drugs in Development

01

Pfizer Inc

U.S.A

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02

Pfizer Inc

U.S.A

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03

Pfizer Inc

U.S.A

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04

Pfizer Inc

U.S.A

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05

Pfizer Inc

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06

Pfizer Inc

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INTERMEDIATES SUPPLIERS

01

Almelo

India

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DATA COMPILATION #PharmaFlow

FDA approvals rise 49% in 2023; CRISPR’s gene editing therapy sees light of day

FDA approvals rise 49% in 2023; CRISPR’s gene editing therapy sees light of day

In 2022, when the US Food and Drug Administration (FDA) was reeling under the impact of the pandemic, new drug approvals by the agency dropped by 26 percent. But last year, FDA’s new drug approvals rebounded by an impressive 49 percent, with the Center for Drug Evaluation and Research (CDER) approving 55 new drugs in 2023. Of them, 36 percent were considered first-in-class, while small molecules made up for 62 percent of the total drugs approved (i.e. 34). FDA’s Center for Biologics Evaluation and Research (CBER) okayed 19 biologics in 2023 compared to eight in the previous year.The first half of 2023 saw the debut of vaccines for the all-too-common respiratory syncytial virus (RSV). Among the other notable approvals in H1 was Biogen and Eisai’s Alzheimer’s drug Leqembi (lecanemab). Out of the total 55 drug approvals, 29 came in H2 2023. This includes Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy that relies on the Nobel Prize-winning CRISPR gene-editing technology. Casgevy has been approved as a treatment for sickle-cell disease (SCD) and β-thalassemia.While FDA witnessed a sharp rise in approvals in 2023, many other drug regulators didn’t. The European Medicines Agency (EMA) granted marketing authorization to 32 novel drugs in 2023, a fall from 33 in 2022. Similarly, Health Canada’s approvals in 2023 decreased to 38, compared to 45 in the previous year.As usual, oncology topped the list of drug approvals by therapeutic area, at 39 (as opposed to 35 in 2022). Rare diseases was the second most popular therapeutic area for drug approvals. With drugmakers clearly paying heed to the unmet needs of patients suffering from rare diseases, this therapeutic area sprinted from a 9 percent share and the fourth position among new approvals in 2022 to an impressive 34 percent share in 2023. A quarter of the new drug approvals were in infectious diseases, followed by immunology (19 percent) and neurology (7 percent).View New Drug Approvals in 2023 with Estimated Sales (Free Excel Available) Casgevy, postpartum depression drug Zurzuvae emerge as potential blockbustersGene therapy Casgevy, postpartum depression (PPD) med Zurzuvae, blood cancer med Elrexfio and ulcerative colitis drug Velsipity were some of the prominent approvals of 2023.Britain’s Medicines and Healthcare products Regulatory Agency was the first to okay Casgevy in November as a cure for SCD and β-thalassemia. Soon, the FDA approved it for SCD. In January this year, the American agency also approved it for transfusion-dependent β-thalassemia (TDT). Analysts estimate Casgevy to generate US$ 2.6 billion in peak sales, says Nature. Biogen and Sage’s PPD therapy Zurzuvae became the first and only FDA-approved pill for the condition that can be life-threatening for both the mother and the child. Global sales of Zurzuvae are forecast to hit US$ 1.28 billion by 2028.In August, Pfizer’s Elrexfio (elranatamab) became the first “off-the-shelf” (ready-to-use) therapy in the US for multiple myeloma. The drug provides an option for patients with hard to treat or relapsed blood cancer and is estimated to bring in US$ 861 million in peak sales by 2028, says Nature.Pfizer also bagged another significant approval in October — its drug Velsipity (etrasimod) was greenlit by the FDA to treat adults with ulcerative colitis, an inflammatory bowel disease. Peak revenue for Velsipity is expected to come in at US$ 825 million, as per Evaluate.View New Drug Approvals in 2023 with Estimated Sales (Free Excel Available) Astra’s Truqap, GSK’s Ojjaara among top cancer therapies given FDA nod in H2In November, FDA approved AstraZeneca’s Truqap (capivasertib) in combination with the Anglo-Swedish drugmaker’s Faslodex (fulvestrant) for treating adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations. Evaluate Pharma forecasts peak Truqap sales to come in at about US$ 690 million.In September, FDA approved GSK’s Ojjaara (momelotinib) as the first and only treatment for myelofibrosis with anemia. Nearly all myelofibrosis patients are estimated to develop anemia over the course of the disease. Ojjaara is taken orally once a day.Other notable oncology treatments okayed by FDA in H2 2023 include Daiichi’s Vanflyta (quizartinib) in July to treat an aggressive blood cancer known as acute myeloid leukemia (AML). In August, FDA approved Janssen’s bispecific antibody Talvey (talquetamab-tgvs) for difficult-to-treat blood cancer. The agency approved two cancer therapies in November — BMS’ Augtyro (repotrectinib) for ROS1-positive non-small cell lung cancer (NSCLC) and Takeda’s targeted oral therapy Fruzaqla (fruquintinib) for adult patients with metastatic colorectal cancer (mCRC).View New Drug Approvals in 2023 with Estimated Sales (Free Excel Available) Rare disease drugs Santhera-Catalyst’s Agamree, Novo’s Rivfloza bag approval in H2In October, FDA approved Santhera Pharmaceuticals and Catalyst Pharma’s Agamree (vamorolone), an oral suspension treatment for Duchenne muscular dystrophy (DMD) in patients two years of age and older. This makes it the first drug fully approved in both the US and Europe for the muscle degeneration disorder. Agamree acts in a manner similar to other steroids, which are the standard of care for the inherited rare disease. However, it causes fewer side effects.FDA also okayed Novo Nordisk’s once-a-month injection Rivfloza (nedosiran) in October to treat a rare genetic condition — primary hyperoxaluria type 1 (PH1) — that causes recurring kidney stones.In November, the agency approved Takeda’s Adzynma (ADAMTS13, recombinant-krhn) as the first treatment for both adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP), a rare genetic blood disorder. Other noteworthy FDA approvals in H2 2023 for rare blood diseases include Novartis’ Fabhalta and bluebird bio's Lyfgenia. Fabhalta is the first oral monotherapy for the treatment of adults with paroxysmal nocturnal hemoglobinuria, a rare disease that causes symptoms such as hemolytic anemia, hemoglobinuria (excretion of hemoglobin in the urine), fatigue, shortness of breath etc. Lyfgenia is the first cell-based gene therapy for the treatment of SCD in patients 12 years and older. Similarly, another rare disease drug — Regeneron’s Veopoz — bagged FDA approval in August last. Veopoz treats CHAPLE disease, an ultra-rare disease in which patients have severe gastrointestinal problems.View New Drug Approvals in 2023 with Estimated Sales (Free Excel Available) Our viewAfter a lull in 2022, new drug approvals have finally gathered momentum. The good news is that this year, several pathbreaking drugs are coming up for approval, such as Madrigal Pharmaceuticals’ resmetirom (the first treatment for NASH with liver fibrosis), Merck’s sotatercept (a treatment for pulmonary arterial hypertension), Lilly’s donanemab for Alzheimer’s disease and Karuna Therapeutics’ drug to treat schizophrenia. Let’s hope 2024 turns out to be an even bigger year for new drug approvals.

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APIs

USP Grade Ritlecitinib API needed in Bangladesh [ENA18099]

A company that focuses on research, development & manufacturing of OSDs, syrups and injectables is looking for suppliers of USP Grade Ritlecitinib API for development purposes. The suppliers must support this enquiry with CoA.

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20 Sep 2023

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Patents & EXCLUSIVITIES

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US Patents

01

PFIZER

RITLECITINIB TOSYLATE

Pharma, Lab & Chemical Expo

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02

PFIZER

RITLECITINIB TOSYLATE

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03

PFIZER

RITLECITINIB TOSYLATE

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ABOUT THIS PAGE

Ritlecitinib Manufacturers

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

Ritlecitinib Suppliers

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

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

Ritlecitinib GMP

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

Ritlecitinib CoA

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

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

Ritlecitinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Ritlecitinib EP), Ritlecitinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ritlecitinib 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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