Synopsis
0
CEP/COS
0
VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
JDMF 
NDC
KDMF
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
NDC
Jai Radhe Sales is your partner for all your sourcing needs.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
CA, ASMF
JPN Pharma offers excellence in API manufacturing through precision, innovation & quality, delivering solutions to the pharma industry
NDC
ASMF
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-07
Pay. Date : 2012-11-27
DMF Number : 20543
Submission : 2007-05-09
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2015-11-13
Pay. Date : 2015-11-05
DMF Number : 20841
Submission : 2007-09-07
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-11-09
DMF Number : 20868
Submission : 2007-09-20
Status :
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-06
Pay. Date : 2013-05-22
DMF Number : 19549
Submission : 2006-06-20
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]JDMF
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
Registration Number : 230MF10010
Registrant's Address : 5 Rupnicu Street, Olain, LV-2114, Latvia
Initial Date of Registration : 2018-01-24
Latest Date of Registration : 2018-01-24
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
Registration Number : 230MF10048
Registrant's Address : 5 Rupnicu Street, Olain, LV-2114, Latvia
Initial Date of Registration : 2018-03-30
Latest Date of Registration : 2018-03-30
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]KDMF
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
Registrant Name : Eltek Pharmachem Co., Ltd.
Registration Date : 2020-05-22
Registration Number : 20200522-209-J-377
Manufacturer Name : JSC OlainFarm
Manufacturer Address : 5, Rupnicu Street, Olaine, LV-2114, Latvia
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
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
CAS Number : 702-79-4
End Use API : Memantine Hydrochloride
About The Company : Olpha, the subsidiary of JSC AB City, is one of the largest companies in the Baltic states with 50 years of experience in the production of medicines & chemical...
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
1-Chloro-3,5-dimethyladamantane
CAS Number : 707-36-8
End Use API : Memantine Hydrochloride
About The Company : Olpha, the subsidiary of JSC AB City, is one of the largest companies in the Baltic states with 50 years of experience in the production of medicines & chemical...
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
1-Hydroxy-3,5-dimethyladamantane
CAS Number : 707-37-9
End Use API : Memantine Hydrochloride
About The Company : Olpha, the subsidiary of JSC AB City, is one of the largest companies in the Baltic states with 50 years of experience in the production of medicines & chemical...
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
1-Acetylamido-3,5-dimethyladamantane
CAS Number : 19982-07-1
End Use API : Memantine Hydrochloride
About The Company : Olpha, the subsidiary of JSC AB City, is one of the largest companies in the Baltic states with 50 years of experience in the production of medicines & chemical...
Suanfarma, at the Core of a Better Life.
CAS Number : 281-23-2
End Use API : Memantine Hydrochloride
About The Company : Suanfarma is a B2B life sciences company dedicated to health and advancement. To achieve this, the company focuses on developing, manufacturing, and distributin...
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]DRUG PRODUCT COMPOSITIONS
DOSAGE - TABLET;ORAL - 10MG
USFDA APPLICATION NUMBER - 21487
DOSAGE - TABLET;ORAL - 5MG
USFDA APPLICATION NUMBER - 21487
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 14M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 14MG
USFDA APPLICATION NUMBER - 22525
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 21M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 21MG
USFDA APPLICATION NUMBER - 22525
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 28M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 28MG
USFDA APPLICATION NUMBER - 22525
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 7MG...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22525
Related Excipient Companies
EUROAPI
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Minakem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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]Pharm-RX Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
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]Shanghai Minbiotech
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]Kirsch Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
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]Aeon Procare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
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]Avesta Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Bioplus Life Sciences
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CD Formulation
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Clariant
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Esteem Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
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]Ideal Cures
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]Lonza Capsugel
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]Nitika Pharmaceutical Specialities
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
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]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
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]Shanghai Welltone Material 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]Silverline Chemicals
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]Ulanqab Kema New Material
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Valens Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Vasa Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Vertellus
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Zhejiang Huakang Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Coating Systems & Additives
Thickeners and Stabilizers
Granulation
Direct Compression
Controlled & Modified Release
Disintegrants & Superdisintegrants
Film Formers & Plasticizers
Lubricants & Glidants
Topical
Taste Masking
Solubilizers
Parenteral
Co-Processed Excipients
Chewable & Orodispersible Aids
Empty Capsules
Emulsifying Agents
Rheology Modifiers
API Stability Enhancers
Coloring Agents
Vegetarian Capsules
Surfactant & Foaming Agents
Soft Gelatin
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]Market Place
US Patents
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
ABOUT THIS PAGE
99
PharmaCompass offers a list of Memantine 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 Memantine Hydrochloride manufacturer or Memantine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Memantine Hydrochloride manufacturer or Memantine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Memantine Hydrochloride API Price utilized in the formulation of products. Memantine Hydrochloride API Price is not always fixed or binding as the Memantine Hydrochloride Price is obtained through a variety of data sources. The Memantine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A SUN Y7017 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of SUN Y7017, including repackagers and relabelers. The FDA regulates SUN Y7017 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. SUN Y7017 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 SUN Y7017 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A SUN Y7017 supplier is an individual or a company that provides SUN Y7017 active pharmaceutical ingredient (API) or SUN Y7017 finished formulations upon request. The SUN Y7017 suppliers may include SUN Y7017 API manufacturers, exporters, distributors and traders.
click here to find a list of SUN Y7017 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A SUN Y7017 DMF (Drug Master File) is a document detailing the whole manufacturing process of SUN Y7017 active pharmaceutical ingredient (API) in detail. Different forms of SUN Y7017 DMFs exist exist since differing nations have different regulations, such as SUN Y7017 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A SUN Y7017 DMF submitted to regulatory agencies in the US is known as a USDMF. SUN Y7017 USDMF includes data on SUN Y7017's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The SUN Y7017 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of SUN Y7017 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 SUN Y7017 Drug Master File in Japan (SUN Y7017 JDMF) empowers SUN Y7017 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 SUN Y7017 JDMF during the approval evaluation for pharmaceutical products. At the time of SUN Y7017 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 SUN Y7017 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 SUN Y7017 Drug Master File in Korea (SUN Y7017 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of SUN Y7017. The MFDS reviews the SUN Y7017 KDMF as part of the drug registration process and uses the information provided in the SUN Y7017 KDMF to evaluate the safety and efficacy of the drug.
After submitting a SUN Y7017 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 SUN Y7017 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of SUN Y7017 suppliers with KDMF on PharmaCompass.
A SUN Y7017 written confirmation (SUN Y7017 WC) is an official document issued by a regulatory agency to a SUN Y7017 manufacturer, verifying that the manufacturing facility of a SUN Y7017 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting SUN Y7017 APIs or SUN Y7017 finished pharmaceutical products to another nation, regulatory agencies frequently require a SUN Y7017 WC (written confirmation) as part of the regulatory process.
click here to find a list of SUN Y7017 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 SUN Y7017 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for SUN Y7017 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 SUN Y7017 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 SUN Y7017 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a SUN Y7017 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of SUN Y7017 suppliers with NDC on PharmaCompass.
SUN Y7017 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 SUN Y7017 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 SUN Y7017 GMP manufacturer or SUN Y7017 GMP API supplier for your needs.
A SUN Y7017 CoA (Certificate of Analysis) is a formal document that attests to SUN Y7017's compliance with SUN Y7017 specifications and serves as a tool for batch-level quality control.
SUN Y7017 CoA mostly includes findings from lab analyses of a specific batch. For each SUN Y7017 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.
SUN Y7017 may be tested according to a variety of international standards, such as European Pharmacopoeia (SUN Y7017 EP), SUN Y7017 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (SUN Y7017 USP).
