Synopsis
0
CEP/COS
0
JDMF
0
KDMF
0
VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
Click Us!
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Sumar Biotech work together to Innovate & Manufacture Semi-synthetic, Synthetic & Fermentation API.
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6291
Submission : 1986-04-25
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
About the Company : With more than 50 years of experience and expertise, Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology comp...
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
About the Company : Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically...
Sumar Biotech work together to Innovate & Manufacture Semi-synthetic, Synthetic & Fermentation API.
About the Company : Sumar Biotech LLP, registered in January 2018, is a startup approved by the Gujarat State Biotechnology Mission. It was founded by emerging entrepreneurs and a team of young yet ex...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
Lead Product(s) : Triptorelin Pamoate
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Debiopharm
Deal Size : Undisclosed
Deal Type : Partnership
Debiopharm And Aspen Partner To Launch Prostate Cancer Drug Trelstar® In South Africa
Details : Debiopharm to enter into this new alliance with Aspen, a well-established and trusted pharmaceutical partner for the commercialization of Trelstar® in South Africa and recognize the therapeutic benefits that Trelstar® could bring to prostate cancer pat...
Product Name : Trelstar
Product Type : Hormone
Upfront Cash : Undisclosed
January 02, 2022
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]South Africa
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - INJECTABLE;INTRAMUSCULAR - EQ 3.75MG...DOSAGE - INJECTABLE;INTRAMUSCULAR - EQ 3.75MG BASE/VIAL
USFDA APPLICATION NUMBER - 20715
DOSAGE - INJECTABLE;INTRAMUSCULAR - EQ 11.25M...DOSAGE - INJECTABLE;INTRAMUSCULAR - EQ 11.25MG BASE/VIAL
USFDA APPLICATION NUMBER - 21288
DOSAGE - INJECTABLE;INTRAMUSCULAR - EQ 22.5MG...DOSAGE - INJECTABLE;INTRAMUSCULAR - EQ 22.5MG BASE/VIAL
USFDA APPLICATION NUMBER - 22437
Related Excipient Companies
Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ashland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Keval Exports
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders, Taste Masking
Excipient Details : Mannitol is used as a filler, bulking agent and taste masking agent in ODT formulations such as tablets.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Granule / Pellet, Tablet
Grade : Oral
Application : Fillers, Diluents & Binders, Granulation, Solubilizers
Excipient Details : Mannogem (mannitol powder) is an excellent excipient for use in wet granulation, lyophilization & improves solubility of poorly soluble APIs.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Dosage Form : Tablet
Grade : Oral
Application : Co-Processed Excipients
Excipient Details : Mannitol is a co-processed excipient with superior compactibility, lower disintegration time, and hygroscopicity.
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : Mpressol (Mannitol) is a polyol used as a filler in tablet formulations, sugar-free solutions and as a bulking agent in freeze-dried products.
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
Dosage Form : Injectable / Parenteral, Tablet
Grade : Parenteral, Oral
Application : Fillers, Diluents & Binders, Parenteral, Thickeners and Stabilizers
Excipient Details : D-mannitol protects proteins from denaturation & degradation. It is also used as a stabilizer in liquid formulations & as a bulking agent in tablets.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking
Excipient Details : Pharmaburst® 500 is a directly compressible, co-processed pharmaceutical excipient used to create orally disintegrating tablets quickly and easily.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Capsule, Cream / Lotion / Ointment, Emulsion, Suspension, Tablet
Grade : Topical, Oral
Brand Name : Carboxymethyl Cellulose
Application : Coating Systems & Additives, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Thickeners and Stabilizers
Excipient Details : Carboxymethylcellulose serves as a disintegrant, binder, coating agent & thickener in oral formulations, also as a stabilizer in topical formulations.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet, Orodispersible Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Taste Masking
Excipient Details : Advantol® 300 is a DC pharmaceutical excipient used to create soft chew or fast melt oral dosage forms through co-processing technology.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet, Orodispersible Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders, Taste Masking
Excipient Details : Compressol® SM, co-processed polyol, is a DC excipient of mannitol & sorbitol with superior compactibility, low disintegration time & hygroscopicity.
Solubilizers
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Granule / Pellet, Tablet
Grade : Oral
Application : Fillers, Diluents & Binders, Granulation, Solubilizers
Excipient Details : Mannogem (mannitol powder) is an excellent excipient for use in wet granulation, lyophilization & improves solubility of poorly soluble APIs.
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Capsule, Cream / Lotion / Ointment, Emulsion, Gel, Injectable / Parenteral, Suspension, Tablet
Grade : Parenteral, Oral, Topical
Application : Emulsifying Agents, Film Formers & Plasticizers, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Excipient Details : Polysorbate 80 is used as a plasticizer, solubilizer, emulsifier, surfactant, and suspension stabilizer. It is also used in parenteral products.
Direct Compression
Chewable & Orodispersible Aids
Thickeners and Stabilizers
Taste Masking
Parenteral
Co-Processed Excipients
Disintegrants & Superdisintegrants
Rheology Modifiers
Topical
Emulsifying Agents
Film Formers & Plasticizers
Granulation
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Granule / Pellet, Tablet
Grade : Oral
Application : Fillers, Diluents & Binders, Granulation, Solubilizers
Excipient Details : Mannogem (mannitol powder) is an excellent excipient for use in wet granulation, lyophilization & improves solubility of poorly soluble APIs.
Surfactant & Foaming Agents
Coating Systems & Additives
API Stability Enhancers
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Regulatory FDF Prices
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Annual Reports
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
APIs
Reply
08 May 2025
Reply
02 Sep 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
FDF DOSSIERS
Reply
08 Aug 2019
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
US Patents
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
93
PharmaCompass offers a list of Triptorelin Pamoate 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 Triptorelin Pamoate manufacturer or Triptorelin Pamoate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Triptorelin Pamoate manufacturer or Triptorelin Pamoate supplier.
PharmaCompass also assists you with knowing the Triptorelin Pamoate API Price utilized in the formulation of products. Triptorelin Pamoate API Price is not always fixed or binding as the Triptorelin Pamoate Price is obtained through a variety of data sources. The Triptorelin Pamoate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Triptorelin Pamoate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Triptorelin Pamoate, including repackagers and relabelers. The FDA regulates Triptorelin Pamoate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Triptorelin Pamoate 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 Triptorelin Pamoate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Triptorelin Pamoate supplier is an individual or a company that provides Triptorelin Pamoate active pharmaceutical ingredient (API) or Triptorelin Pamoate finished formulations upon request. The Triptorelin Pamoate suppliers may include Triptorelin Pamoate API manufacturers, exporters, distributors and traders.
click here to find a list of Triptorelin Pamoate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Triptorelin Pamoate DMF (Drug Master File) is a document detailing the whole manufacturing process of Triptorelin Pamoate active pharmaceutical ingredient (API) in detail. Different forms of Triptorelin Pamoate DMFs exist exist since differing nations have different regulations, such as Triptorelin Pamoate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Triptorelin Pamoate DMF submitted to regulatory agencies in the US is known as a USDMF. Triptorelin Pamoate USDMF includes data on Triptorelin Pamoate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Triptorelin Pamoate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Triptorelin Pamoate suppliers with USDMF on PharmaCompass.
A Triptorelin Pamoate written confirmation (Triptorelin Pamoate WC) is an official document issued by a regulatory agency to a Triptorelin Pamoate manufacturer, verifying that the manufacturing facility of a Triptorelin Pamoate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Triptorelin Pamoate APIs or Triptorelin Pamoate finished pharmaceutical products to another nation, regulatory agencies frequently require a Triptorelin Pamoate WC (written confirmation) as part of the regulatory process.
click here to find a list of Triptorelin Pamoate suppliers with Written Confirmation (WC) on PharmaCompass.
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 Triptorelin Pamoate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Triptorelin Pamoate API and other APIs are published in this directory by the FDA.
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 Triptorelin Pamoate 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.
The NDC directory also contains data on finished compounded human drug products that contain Triptorelin Pamoate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Triptorelin Pamoate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Triptorelin Pamoate suppliers with NDC on PharmaCompass.
Triptorelin Pamoate 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 Triptorelin Pamoate 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 Triptorelin Pamoate GMP manufacturer or Triptorelin Pamoate GMP API supplier for your needs.
A Triptorelin Pamoate CoA (Certificate of Analysis) is a formal document that attests to Triptorelin Pamoate's compliance with Triptorelin Pamoate specifications and serves as a tool for batch-level quality control.
Triptorelin Pamoate CoA mostly includes findings from lab analyses of a specific batch. For each Triptorelin Pamoate 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.
Triptorelin Pamoate may be tested according to a variety of international standards, such as European Pharmacopoeia (Triptorelin Pamoate EP), Triptorelin Pamoate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Triptorelin Pamoate USP).
Comment (2)
