Synopsis
0
CEP/COS
0
JDMF
0
EU WC
0
KDMF
0
VMF
DRUG PRODUCT COMPOSITIONS
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!
Vtides Life Sciences: Innovating peptide design and synthesis for advanced, targeted therapies across key disease areas.
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Mesochem is focused on incessant innovation along with the R&D of new APIs.
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 : 8509
Submission : 1990-04-04
Status :
Type : II
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...
Vtides Life Sciences: Innovating peptide design and synthesis for advanced, targeted therapies across key disease areas.
About the Company : Vtides Life Sciences Pvt Ltd specializes in the design and synthesis of complex peptides, employing advanced chemical strategies such as microwave-assisted solid-phase synthesis, p...
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
About the Company : Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs ...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
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...
Mesochem is focused on incessant innovation along with the R&D of new APIs.
About the Company : Beijing Mesochem Technology Co. Ltd., which is located in the national economic and technological development area of Yizhuang, China, manufactures pharmaceutical chemicals, fine c...
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) : Teriparatide
Therapeutic Area : Musculoskeletal
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : USFDA approved biosimilar, Kauliv (human teriparatide hormone), for the treatment of both men and postmenopausal women with osteoporosis who are at high risk for having broken bones or fractures.
Product Name : Kauliv
Product Type : Peptide
Upfront Cash : Inapplicable
November 14, 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
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 0.25MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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
APIs
Reply
26 Aug 2024
Reply
26 Nov 2022
Reply
23 Nov 2021
Reply
09 May 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
FDF DOSSIERS
Reply
09 Nov 2020
Reply
23 May 2020
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
66
PharmaCompass offers a list of Teriparatide 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 Teriparatide manufacturer or Teriparatide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Teriparatide manufacturer or Teriparatide supplier.
PharmaCompass also assists you with knowing the Teriparatide API Price utilized in the formulation of products. Teriparatide API Price is not always fixed or binding as the Teriparatide Price is obtained through a variety of data sources. The Teriparatide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A FT-0656763 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of FT-0656763, including repackagers and relabelers. The FDA regulates FT-0656763 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. FT-0656763 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 FT-0656763 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A FT-0656763 supplier is an individual or a company that provides FT-0656763 active pharmaceutical ingredient (API) or FT-0656763 finished formulations upon request. The FT-0656763 suppliers may include FT-0656763 API manufacturers, exporters, distributors and traders.
click here to find a list of FT-0656763 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A FT-0656763 DMF (Drug Master File) is a document detailing the whole manufacturing process of FT-0656763 active pharmaceutical ingredient (API) in detail. Different forms of FT-0656763 DMFs exist exist since differing nations have different regulations, such as FT-0656763 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A FT-0656763 DMF submitted to regulatory agencies in the US is known as a USDMF. FT-0656763 USDMF includes data on FT-0656763's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The FT-0656763 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of FT-0656763 suppliers with USDMF 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 FT-0656763 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for FT-0656763 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 FT-0656763 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 FT-0656763 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a FT-0656763 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of FT-0656763 suppliers with NDC on PharmaCompass.
FT-0656763 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 FT-0656763 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 FT-0656763 GMP manufacturer or FT-0656763 GMP API supplier for your needs.
A FT-0656763 CoA (Certificate of Analysis) is a formal document that attests to FT-0656763's compliance with FT-0656763 specifications and serves as a tool for batch-level quality control.
FT-0656763 CoA mostly includes findings from lab analyses of a specific batch. For each FT-0656763 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.
FT-0656763 may be tested according to a variety of international standards, such as European Pharmacopoeia (FT-0656763 EP), FT-0656763 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (FT-0656763 USP).
Comment (5)
