SEP-363856

Synopsis, Chemistry

APIs // Active Pharmaceutical Ingredients

1 NDC API

1 NDC API

DEVELOPMENTS

5 Drug(s) in Development

5 Drug(s) in Development

DIGITAL CONTENT

1 News

1 News

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F.I.S. FABBRICA ITALIANA SINTETICI ...

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ULOTARONT HYDROCHLORIDE

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Active Ingredient

ULOTARONT HYDROCHLORIDE

Dosage Form (Strength)

POWDER (1kg/kg)

Marketing Category

BULK INGREDIENT

NDC Package Code

48087-0161

Start Marketing Date

2022-11-03

End Marketing Date

2024-12-31

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Looking for 1310426-33-5 / Ulotaront API manufacturers, exporters & distributors?

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

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

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

API | Excipient name

Ulotaront

Synonyms

Sep-363856, Unii-3k6270mg59, Sep-856, 1310426-33-5, 1-[(7s)-5,7-dihydro-4h-thieno[2,3-c]pyran-7-yl]-n-methylmethanamine, 3k6270mg59

Cas Number

1310426-33-5

Unique Ingredient Identifier (UNII)

3K6270MG59

About Ulotaront

SEP-363856 is a novel psychotropic drug being investigated for the treatment of schizophrenia. Unlike other drugs used for this condition, SEP-363856 does not bind to the dopamine D2 receptors, but exerts actions on the trace amineassociated receptor 1 (TAAR1) and 5-hydroxytryptamine type 1A (5-HT1A). SEP-363856 was developed by Sunovion pharmaceuticals. An initial clinical study has shown this drug may be effective against both positive and negative symptoms of schizophrenia. Negative symptoms of schizophrenia are more difficult to treat and may include flattened affect, anhedonia, and social withdrawal. Additional clinical trials of SEP-363856 are required to confirm the safety and efficacy of this drug.

SEP-363856 Manufacturers

A SEP-363856 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of SEP-363856, including repackagers and relabelers. The FDA regulates SEP-363856 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. SEP-363856 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

SEP-363856 Suppliers

A SEP-363856 supplier is an individual or a company that provides SEP-363856 active pharmaceutical ingredient (API) or SEP-363856 finished formulations upon request. The SEP-363856 suppliers may include SEP-363856 API manufacturers, exporters, distributors and traders.

SEP-363856 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 SEP-363856 as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for SEP-363856 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 SEP-363856 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 SEP-363856 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a SEP-363856 NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of SEP-363856 suppliers with NDC on PharmaCompass.

SEP-363856 Manufacturers | Traders | Suppliers

We have 1 companies offering SEP-363856

Get in contact with the supplier of your choice:

F.I.S. Fabbrica Italiana Sintetici

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.