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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]DRUG PRODUCT COMPOSITIONS
DOSAGE - FOR SUSPENSION;INTRAMUSCULAR - EQ 10...DOSAGE - FOR SUSPENSION;INTRAMUSCULAR - EQ 10MG BASE/VIAL
USFDA APPLICATION NUMBER - 203255
DOSAGE - FOR SUSPENSION;INTRAMUSCULAR - EQ 20...DOSAGE - FOR SUSPENSION;INTRAMUSCULAR - EQ 20MG BASE/VIAL
USFDA APPLICATION NUMBER - 203255
DOSAGE - FOR SUSPENSION;INTRAMUSCULAR - EQ 30...DOSAGE - FOR SUSPENSION;INTRAMUSCULAR - EQ 30MG BASE/VIAL
USFDA APPLICATION NUMBER - 203255
DOSAGE - FOR SUSPENSION;INTRAMUSCULAR - EQ 40...DOSAGE - FOR SUSPENSION;INTRAMUSCULAR - EQ 40MG BASE/VIAL
USFDA APPLICATION NUMBER - 203255
DOSAGE - FOR SUSPENSION;INTRAMUSCULAR - EQ 60...DOSAGE - FOR SUSPENSION;INTRAMUSCULAR - EQ 60MG BASE/VIAL
USFDA APPLICATION NUMBER - 203255
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
A Pasireotide Pamoate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pasireotide Pamoate, including repackagers and relabelers. The FDA regulates Pasireotide Pamoate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pasireotide 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.
A Pasireotide Pamoate supplier is an individual or a company that provides Pasireotide Pamoate active pharmaceutical ingredient (API) or Pasireotide Pamoate finished formulations upon request. The Pasireotide Pamoate suppliers may include Pasireotide Pamoate API manufacturers, exporters, distributors and traders.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Pasireotide Pamoate Drug Master File in Korea (Pasireotide Pamoate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Pasireotide Pamoate. The MFDS reviews the Pasireotide Pamoate KDMF as part of the drug registration process and uses the information provided in the Pasireotide Pamoate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Pasireotide Pamoate 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 Pasireotide Pamoate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Pasireotide Pamoate suppliers with KDMF on PharmaCompass.
Pasireotide 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 Pasireotide 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 Pasireotide Pamoate GMP manufacturer or Pasireotide Pamoate GMP API supplier for your needs.
A Pasireotide Pamoate CoA (Certificate of Analysis) is a formal document that attests to Pasireotide Pamoate's compliance with Pasireotide Pamoate specifications and serves as a tool for batch-level quality control.
Pasireotide Pamoate CoA mostly includes findings from lab analyses of a specific batch. For each Pasireotide 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.
Pasireotide Pamoate may be tested according to a variety of international standards, such as European Pharmacopoeia (Pasireotide Pamoate EP), Pasireotide Pamoate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pasireotide Pamoate USP).
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