Samidorphan L-Malate API Manufacturers | Suppliers | Drug Master Files (DMF) | CEP

01

Metrochem API Private Limited

India

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

CPhI Japan

Booth #6F-26

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

Contact Supplier

India

Virtual Booth

Digital Content

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

02

TAPI Technology & API Services

Israel

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

CPhI Japan

Attending

TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

Contact Supplier

Israel

Virtual Booth

Digital Content

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

03

Teva Pharmaceutical Industries

Israel

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

BePharma

Not Confirmed

04

MSN Laboratories

India

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

BePharma

Not Confirmed

05

Curia

U.S.A

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

BePharma

Not Confirmed

Looking for 852626-89-2 / Samidorphan L-Malate API manufacturers, exporters & distributors?

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API | Excipient name

Samidorphan L-Malate

Synonyms

852626-89-2, Alks 33, Alks-33, Samidorphan [usan], Rdc-0313-00, Chembl426084

Cas Number

852626-89-2

Unique Ingredient Identifier (UNII)

7W2581Z5L8

About Samidorphan L-Malate

[Olanzapine] is an effective atypical antipsychotic that, like other antipsychotics, is associated with weight gain, metabolic dysfunction, and increased risk of type II diabetes. Samidorphan is a novel opioid antagonist structurally related to [naltrexone], with a higher affinity for opioid receptors, more potent -opioid receptor antagonism, higher oral bioavailability, and a longer half-life, making it an attractive candidate for oral dosing. Although antipsychotic-induced weight gain is incompletely understood, it is thought that the opioid system plays a key role in feeding and metabolism, such that opioid antagonism may be expected to ameliorate these negative effects. Samidorphan has been shown in animal models and clinical trials to ameliorate [olanzapine]-induced weight gain and metabolic dysfunction. Samidorphan was first approved as a variety of fixed-dose combination tablets with [olanzapine] by the FDA on May 28, 2021, and is currently marketed under the trademark LYBALVI by Alkermes Inc.

Samidorphan L-Malate Manufacturers

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

Samidorphan L-Malate Suppliers

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

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

Samidorphan L-Malate Manufacturers | Traders | Suppliers

We have 5 companies offering Samidorphan L-Malate

Get in contact with the supplier of your choice:

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.