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Looking for 1353550-13-6 / Olmutinib API manufacturers, exporters & distributors?

Olmutinib manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Olmutinib 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 Olmutinib manufacturer or Olmutinib supplier for your needs.

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

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

API | Excipient name

Olmutinib

Synonyms

1353550-13-6, Hm61713, Bi 1482694, 1802181-20-9, Olmutinib [inn], Hm-61713

Cas Number

1353550-13-6

Unique Ingredient Identifier (UNII)

CHL9B67L95

About Olmutinib

Olmutinib is an orally available small molecule, mutant-selective inhibitor of epidermal growth factor receptor (EGFR) with potential antineoplastic activity. Olmutinib binds to and inhibits mutant forms of EGFR, thereby leading to cell death of EGFR-expressing tumor cells. As this agent is selective towards mutant forms of EGFR, its toxicity profile may be reduced as compared to non-selective EGFR inhibitors which also inhibit the EGFR wild type form.

Olmutinib Manufacturers

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

Olmutinib Suppliers

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

Olmutinib KDMF

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

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

After submitting a Olmutinib 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 Olmutinib API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Olmutinib suppliers with KDMF on PharmaCompass.

Olmutinib GMP

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

Olmutinib CoA

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

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

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