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Looking for 15676-16-1 / Sulpiride API manufacturers, exporters & distributors?

Sulpiride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Sulpiride

Synonyms

15676-16-1, Sulpyrid, Sulpirid, Aiglonyl, Dolmatil, Dogmatil

Cas Number

15676-16-1

Unique Ingredient Identifier (UNII)

7MNE9M8287

About Sulpiride

A dopamine D2-receptor antagonist. It has been used therapeutically as an antidepressant, antipsychotic, and as a digestive aid. (From Merck Index, 11th ed)

Sulpiride Manufacturers

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

Sulpiride Suppliers

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

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

Sulpiride USDMF

A Sulpiride DMF (Drug Master File) is a document detailing the whole manufacturing process of Sulpiride active pharmaceutical ingredient (API) in detail. Different forms of Sulpiride DMFs exist exist since differing nations have different regulations, such as Sulpiride USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Sulpiride DMF submitted to regulatory agencies in the US is known as a USDMF. Sulpiride USDMF includes data on Sulpiride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sulpiride USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Sulpiride suppliers with USDMF on PharmaCompass.

Sulpiride JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Sulpiride Drug Master File in Japan (Sulpiride JDMF) empowers Sulpiride API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Sulpiride JDMF during the approval evaluation for pharmaceutical products. At the time of Sulpiride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Sulpiride suppliers with JDMF on PharmaCompass.

Sulpiride KDMF

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

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

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

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

Sulpiride CEP

A Sulpiride CEP of the European Pharmacopoeia monograph is often referred to as a Sulpiride Certificate of Suitability (COS). The purpose of a Sulpiride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sulpiride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sulpiride to their clients by showing that a Sulpiride CEP has been issued for it. The manufacturer submits a Sulpiride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sulpiride CEP holder for the record. Additionally, the data presented in the Sulpiride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sulpiride DMF.

A Sulpiride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sulpiride CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Sulpiride suppliers with CEP (COS) on PharmaCompass.

Sulpiride GMP

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

Sulpiride CoA

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

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

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