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Find Pethidine Hydrochloride manufacturers, exporters & distributors on PharmaCompass

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  • INJECTABLE;INJECTION - 100MG/ML
  • INJECTABLE;INJECTION - 25MG/ML
  • INJECTABLE;INJECTION - 50MG/ML
  • INJECTABLE;INJECTION - 75MG/ML
  • TABLET;ORAL - 100MG
  • TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • INJECTABLE;INJECTION - 10MG/ML

Looking for 50-13-5 / Pethidine Hydrochloride API manufacturers, exporters & distributors?

Pethidine Hydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Pethidine Hydrochloride

Synonyms

50-13-5, Dolantin, Dolargan, Dolcontral, Dolosal, Dolin

Cas Number

50-13-5

Unique Ingredient Identifier (UNII)

N8E7F7Q170

About Pethidine Hydrochloride

A narcotic analgesic that can be used for the relief of most types of moderate to severe pain, including postoperative pain and the pain of labor. Prolonged use may lead to dependence of the morphine type; withdrawal symptoms appear more rapidly than with morphine and are of shorter duration.

(+/-)-Pethidine Hydrochloride Manufacturers

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

(+/-)-Pethidine Hydrochloride Suppliers

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

click here to find a list of (+/-)-Pethidine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

(+/-)-Pethidine Hydrochloride USDMF

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

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

click here to find a list of (+/-)-Pethidine Hydrochloride suppliers with USDMF on PharmaCompass.

(+/-)-Pethidine Hydrochloride 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 (+/-)-Pethidine Hydrochloride Drug Master File in Japan ((+/-)-Pethidine Hydrochloride JDMF) empowers (+/-)-Pethidine Hydrochloride 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 (+/-)-Pethidine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of (+/-)-Pethidine Hydrochloride 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 (+/-)-Pethidine Hydrochloride suppliers with JDMF on PharmaCompass.

(+/-)-Pethidine Hydrochloride CEP

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

A (+/-)-Pethidine Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. (+/-)-Pethidine Hydrochloride 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 (+/-)-Pethidine Hydrochloride suppliers with CEP (COS) on PharmaCompass.

(+/-)-Pethidine Hydrochloride WC

A (+/-)-Pethidine Hydrochloride written confirmation ((+/-)-Pethidine Hydrochloride WC) is an official document issued by a regulatory agency to a (+/-)-Pethidine Hydrochloride manufacturer, verifying that the manufacturing facility of a (+/-)-Pethidine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting (+/-)-Pethidine Hydrochloride APIs or (+/-)-Pethidine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a (+/-)-Pethidine Hydrochloride WC (written confirmation) as part of the regulatory process.

click here to find a list of (+/-)-Pethidine Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.

(+/-)-Pethidine Hydrochloride 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 (+/-)-Pethidine Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

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

click here to find a list of (+/-)-Pethidine Hydrochloride suppliers with NDC on PharmaCompass.

(+/-)-Pethidine Hydrochloride GMP

(+/-)-Pethidine Hydrochloride 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 (+/-)-Pethidine Hydrochloride 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 (+/-)-Pethidine Hydrochloride GMP manufacturer or (+/-)-Pethidine Hydrochloride GMP API supplier for your needs.

(+/-)-Pethidine Hydrochloride CoA

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

(+/-)-Pethidine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each (+/-)-Pethidine Hydrochloride 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.

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