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TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
About the Company : Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout...
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...
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
About the Company : Founded in 1987, Transo-Pharm is a fully licensed and certified global distributor of pharmaceutical components for the health and veterinary industries. The company supports its c...
Comhony Biotech manufactures fermentation & semi-synthetic APIs which aim at dermatology, anti-biotics; mitochondria & memory health.
About the Company : Comhony Biotech is dedicated to supplying APIs and nutraceutical ingredients to worldwide clients in the pharmaceutical and nutraceutical sectors. Leveraging its proprietary techno...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
About the Company : Chunghwa Chemical Synthesis & Biotech Co. Ltd. (CCSB) offers global customers cost-effective APIs with speed, supported by our well-trained staff. As the first company in Southeast...
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...
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Drugs in Development
Lead Product(s) : Dalbavancin
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
DALVANCE FDA Approval Acute Bacterial Skin Structure Infections in Pediatric
Details : The 5 patients in the age group birth to less than 3 months of age were not included in the efficacy analyses since they were enrolled with expanded inclusion criteria and only received the single-dose DALVANCE regimen.
Brand Name : Dalvance
Molecule Type : Peptide
Upfront Cash : Not Applicable
July 23, 2021
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SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet
Grade : Oral
SPI Pharma has been solving formulation challenges using superior functional materials.
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SPI Pharma has been solving formulation challenges using superior functional materials.
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Dosage Form : Tablet
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SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
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SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
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SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet
Grade : Oral
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet
Grade : Oral
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Exclusivity Code : NCE
Exclusivity Expiration Date : 2019-05-23
Application Number : 21883
Product Number : 1
Exclusivity Details :
Exclusivity Code : NPP
Exclusivity Expiration Date : 2024-07-22
Application Number : 21883
Product Number : 1
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Exclusivity Code : GAIN
Exclusivity Expiration Date : 2024-05-23
Application Number : 21883
Product Number : 1
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ABOUT THIS PAGE
A Dalbavancin Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dalbavancin Hydrochloride, including repackagers and relabelers. The FDA regulates Dalbavancin Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dalbavancin Hydrochloride 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 Dalbavancin Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dalbavancin Hydrochloride supplier is an individual or a company that provides Dalbavancin Hydrochloride active pharmaceutical ingredient (API) or Dalbavancin Hydrochloride finished formulations upon request. The Dalbavancin Hydrochloride suppliers may include Dalbavancin Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Dalbavancin Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dalbavancin Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Dalbavancin Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Dalbavancin Hydrochloride DMFs exist exist since differing nations have different regulations, such as Dalbavancin Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dalbavancin Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Dalbavancin Hydrochloride USDMF includes data on Dalbavancin Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dalbavancin Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dalbavancin Hydrochloride 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 Dalbavancin Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dalbavancin Hydrochloride 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 Dalbavancin Hydrochloride 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 Dalbavancin Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dalbavancin Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dalbavancin Hydrochloride suppliers with NDC on PharmaCompass.
Dalbavancin Hydrochloride 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 Dalbavancin Hydrochloride 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 Dalbavancin Hydrochloride GMP manufacturer or Dalbavancin Hydrochloride GMP API supplier for your needs.
A Dalbavancin Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Dalbavancin Hydrochloride's compliance with Dalbavancin Hydrochloride specifications and serves as a tool for batch-level quality control.
Dalbavancin Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Dalbavancin Hydrochloride 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.
Dalbavancin Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Dalbavancin Hydrochloride EP), Dalbavancin Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dalbavancin Hydrochloride USP).
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