Close
4

Bora CDMO Bora CDMO

X

Find Thebaine manufacturers, exporters & distributors on PharmaCompass

PharmaCompass
API SUPPLIERS
API Suppliers

API Suppliers

US DMFs Filed

US DMFs Filed

0

CEP/COS Certifications

CEP/COS Certifications

0

JDMFs Filed

JDMFs Filed

0

Other Certificates

Other Certificates

0

Other Suppliers

Other Suppliers

API REF. PRICE (USD / KG)
INTERMEDIATES

0

DOSSIERS // FDF
USA (Orange Book)

USA (Orange Book)

0

Europe

Europe

0

Canada

Canada

0

Australia

Australia

0

South Africa

South Africa

0

Uploaded Dossiers

Uploaded Dossiers

0

GLOBAL SALES (USD Million)

U.S. Medicaid

0

Annual Reports

0

EXCIPIENTS

0

PATENTS & EXCLUSIVITIES

USFDA Orange Book Patents

0

USFDA Exclusivities

0

DIGITAL CONTENT

Blog #PharmaFlow

0

News

0

REF STANDARD

EDQM

0

USP

0

JP

0

Other Listed Suppliers

0

SERVICES

0

Looking for 115-37-7 / Thebaine API manufacturers, exporters & distributors?

Thebaine manufacturers, exporters & distributors 1

39

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

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

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

API | Excipient name

Thebaine

Synonyms

Paramorphine, 115-37-7, Thebain, 3-o-methyl-oripavin, 4,5alpha-epoxy-3,6-dimethoxy-17-methyl-6,8-morphinadien, 2p9mkg8gx7

Cas Number

115-37-7

Unique Ingredient Identifier (UNII)

2P9MKG8GX7

About Thebaine

A drug that is derived from opium, which contains from 0.3-1.5% thebaine depending on its origin. It produces strychnine-like convulsions rather than narcosis. It may be habit-forming and is a controlled substance (opiate) listed in the U.S. Code of Federal Regulations, Title 21 Part 1308.12 (1985). (From Merck Index, 11th ed)

Thebaine Manufacturers

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

Thebaine Suppliers

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

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

Thebaine 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 Thebaine as an active pharmaceutical ingredient (API).

Finished drug products

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

click here to find a list of Thebaine suppliers with NDC on PharmaCompass.

Thebaine GMP

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

Thebaine CoA

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

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

Thebaine may be tested according to a variety of international standards, such as European Pharmacopoeia (Thebaine EP), Thebaine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Thebaine 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.
Ask Us for Pharmaceutical Supplier and Partner
Ask Us, Find A Supplier / Partner
No Commissions, No Strings Attached, Get Connected for FREE

What are you looking for?

How can we help you?

The request can't be empty

Please read our Privacy Policy carefully

You must agree to the privacy policy

The name can't be empty
The company can't be empty.
The email can't be empty Please enter a valid email.
The mobile can't be empty
Post Enquiry
POST ENQUIRY