Synopsis
0
Australia
DRUG PRODUCT COMPOSITIONS
0
Data Compilation #PharmaFlow
0
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!
JDMF
KDMF
ASolution Pharmaceuticals: Your CDMO Partner for APIs and Specialty Molecules.
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Neuland Laboratories- A dedicated 100% API provider.
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
SNJ Labs: WHO-GMP certified API leader in India, specializing in bulk drugs & intermediates with unmatched expertise.
Together we can improve the quality of life
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 : Complete
Rev. Date : 2013-03-14
Pay. Date : 2012-12-18
DMF Number : 11204
Submission : 1994-11-22
Status :
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27418
Submission : 2013-08-13
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
Certificate Number : CEP 2005-003 - Rev 05
Status : Valid
Issue Date : 2024-09-04
Type : Chemical
Substance Number : 1558
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
Registration Number : 221MF10007
Registrant's Address : Route du simplon 22, CH-1895 Vionnaz-Switzerland
Initial Date of Registration : 2009-01-13
Latest Date of Registration : 2013-03-14
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
ASolution Pharmaceuticals: Your CDMO Partner for APIs and Specialty Molecules.
Date of Issue : 2024-01-23
Valid Till : 2026-06-17
Written Confirmation Number : WC-0476
Address of the Firm : K3/8, Anand Nagar, MIDC., Ambernath (East), Ambernath-421506, District: Thane, M...
Neuland Laboratories- A dedicated 100% API provider.
Date of Issue : 2025-06-27
Valid Till : 2028-06-16
Written Confirmation Number : WC-0037
Address of the Firm : Unit-ll, Plot No. 92-94, 257-259, IDA Pashamylaram, Pashamylaram Village, Patanc...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
Registrant Name : Daewon Pharmaceutical Co., Ltd.
Registration Date : 2023-02-15
Registration Number : 20200806-210-J-463(4)
Manufacturer Name : Bachem SA
Manufacturer Address : Succursale of Vionnaz, Route du Simplon 22, 1895 Vionnaz, Switzerland
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
Registrant Name : Dongkook Pharmaceutical Co., Ltd.
Registration Date : 2021-12-02
Registration Number : 20200806-210-J-463(3)
Manufacturer Name : Bachem SA
Manufacturer Address : Succursale of Vionnaz, Route du Simplon 22, 1895 Vionnaz, Switzerland
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
Registrant Name : B. Braun Korea Co., Ltd.
Registration Date : 2025-11-12
Registration Number : 20200806-210-J-463(5)
Manufacturer Name : Bachem SA
Manufacturer Address : Succursale of Vionnaz, Route du Simplon 22, 1895 Vionnaz, Switzerland
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
Registrant Name : Myeongmun Pharmaceutical Co., Ltd.
Registration Date : 2021-03-02
Registration Number : 20200806-210-J-463(2)
Manufacturer Name : Bachem SA
Manufacturer Address : Succursale of Vionnaz, Route du Simplon 22, 1895 Vionnaz, Switzerland
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
Registrant Name : Fresenius Kabi Korea Co., Ltd.
Registration Date : 2020-08-06
Registration Number : 20200806-210-J-463
Manufacturer Name : Bachem SA
Manufacturer Address : Succursale of Vionnaz, Route du Simplon 22, 1895 Vionnaz, Switzerland
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
Registrant Name : Hana Pharmaceutical Co., Ltd.
Registration Date : 2021-01-18
Registration Number : 20200806-210-J-463(1)
Manufacturer Name : Bachem SA
Manufacturer Address : Succursale of Vionnaz, Route du Simplon 22, 1895 Vionnaz, Switzerland
Neuland Laboratories- A dedicated 100% API provider.
Registrant Name : Myeongmun Pharmaceutical Co., Ltd.
Registration Date : 2021-03-25
Registration Number : 20210325-210-J-630
Manufacturer Name : Neuland Laboratories Limited
Manufacturer Address : Plot Nos 92, 93, 94, 257, 258, 259, IDA, Pashamylaram, Isnapur (V), Patancheru (M), S...
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]VMF
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 : Bachem, with over 50 years of experience, supplies products for research, clinical development, and commercial use to pharmaceutical and biotechnology companies worldwide. It has e...
ASolution Pharmaceuticals: Your CDMO Partner for APIs and Specialty Molecules.
About the Company : Established in 2010, ASolution is an India-based custom developer and manufacturer serving pharmaceutical needs across multiple scales. The company provides process development, op...
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
About the Company : Transo-Pharm is a licensed distributor of pharmaceutical components for human and veterinary markets. The company supports the full API life cycle, from development to sales, and a...
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
About the Company : Founded in 2003, Seqens has evolved into a global leader in pharmaceutical solutions and specialty ingredients. The company supports customers in the development, scale-up, and man...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
Neuland Laboratories- A dedicated 100% API provider.
About the Company : Neuland Laboratories, established in 1984 and headquartered in Hyderabad, is a publicly listed company offering solutions for pharmaceutical chemistry needs—from library compound...
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
About the Company : Supriya Lifescience Limited, established in 1987 and headquartered in Mumbai, is a globally recognized, technology-driven manufacturer of APIs, CDMO, and formulations. Its faciliti...
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
About the Company : Zeon Pharma Industries India Pvt. Ltd. is an ISO 9001:2015, cGMP, and WHO-GMP certified company with a dedicated manufacturing facility for Bulk Drugs (APIs), phytochemicals, herba...
SNJ Labs: WHO-GMP certified API leader in India, specializing in bulk drugs & intermediates with unmatched expertise.
About the Company : SNJ Labs, established in 2013, is India’s largest manufacturer of Iron Sucrose, achieving a production capacity of 120 MT per year within five years. The company specializes in A...
Together we can improve the quality of life
About the Company : Shamrock Pharmachemi Pvt Ltd. is a globally recognized API leader with 26+ years in human and veterinary pharmaceuticals. Operating in 40+ countries, it owns two Gujarat facilities...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
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]Related Excipient Companies
EUROAPI
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kewpie Corporation
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]Kirsch Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Dr. Paul Lohmann GmbH & Co. KGaA
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]Parenteral
Topical
Emulsifying Agents
Solubilizers
Lubricants & Glidants
Thickeners and Stabilizers
Fillers, Diluents & Binders
Film Formers & Plasticizers
API Stability Enhancers
Digital Content
NEWS #PharmaBuzz
Global Sales Information
Market Place
APIs
Reply
16 Apr 2026
Reply
13 Jun 2025
Reply
02 Jun 2025
Reply
22 Mar 2025
Reply
27 Dec 2024
Reply
28 Nov 2024
Reply
18 Oct 2024
Reply
11 Jul 2023
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
37
PharmaCompass offers a list of Propofol API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Propofol manufacturer or Propofol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Propofol manufacturer or Propofol supplier.
A Propovan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Propovan, including repackagers and relabelers. The FDA regulates Propovan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Propovan 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 Propovan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Propovan supplier is an individual or a company that provides Propovan active pharmaceutical ingredient (API) or Propovan finished formulations upon request. The Propovan suppliers may include Propovan API manufacturers, exporters, distributors and traders.
click here to find a list of Propovan suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Propovan DMF (Drug Master File) is a document detailing the whole manufacturing process of Propovan active pharmaceutical ingredient (API) in detail. Different forms of Propovan DMFs exist exist since differing nations have different regulations, such as Propovan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Propovan DMF submitted to regulatory agencies in the US is known as a USDMF. Propovan USDMF includes data on Propovan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Propovan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Propovan suppliers with USDMF on PharmaCompass.
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 Propovan Drug Master File in Japan (Propovan JDMF) empowers Propovan 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 Propovan JDMF during the approval evaluation for pharmaceutical products. At the time of Propovan 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 Propovan suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Propovan Drug Master File in Korea (Propovan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Propovan. The MFDS reviews the Propovan KDMF as part of the drug registration process and uses the information provided in the Propovan KDMF to evaluate the safety and efficacy of the drug.
After submitting a Propovan 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 Propovan API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Propovan suppliers with KDMF on PharmaCompass.
A Propovan CEP of the European Pharmacopoeia monograph is often referred to as a Propovan Certificate of Suitability (COS). The purpose of a Propovan CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Propovan EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Propovan to their clients by showing that a Propovan CEP has been issued for it. The manufacturer submits a Propovan CEP (COS) as part of the market authorization procedure, and it takes on the role of a Propovan CEP holder for the record. Additionally, the data presented in the Propovan CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Propovan DMF.
A Propovan CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Propovan 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 Propovan suppliers with CEP (COS) on PharmaCompass.
A Propovan written confirmation (Propovan WC) is an official document issued by a regulatory agency to a Propovan manufacturer, verifying that the manufacturing facility of a Propovan active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Propovan APIs or Propovan finished pharmaceutical products to another nation, regulatory agencies frequently require a Propovan WC (written confirmation) as part of the regulatory process.
click here to find a list of Propovan 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 Propovan as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Propovan 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 Propovan 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 Propovan and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Propovan NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Propovan suppliers with NDC on PharmaCompass.
Propovan 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 Propovan GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Propovan GMP manufacturer or Propovan GMP API supplier for your needs.
A Propovan CoA (Certificate of Analysis) is a formal document that attests to Propovan's compliance with Propovan specifications and serves as a tool for batch-level quality control.
Propovan CoA mostly includes findings from lab analyses of a specific batch. For each Propovan 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.
Propovan may be tested according to a variety of international standards, such as European Pharmacopoeia (Propovan EP), Propovan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Propovan USP).
Comment (0)
