Close
4

Athena Athena

X

Find Gestodene manufacturers, exporters & distributors on PharmaCompass

PharmaCompass
API SUPPLIERS
API Suppliers

API Suppliers

US DMFs Filed

US DMFs Filed

CEP/COS Certifications

CEP/COS Certifications

JDMFs Filed

JDMFs Filed

0

Other Certificates

Other Certificates

0

Other Suppliers

Other Suppliers

API REF. PRICE (USD / KG)
INTERMEDIATES
DOSSIERS // FDF
USA (Orange Book)

USA (Orange Book)

0

Europe

Europe

Canada

Canada

0

Australia

Australia

0

South Africa

South Africa

Uploaded Dossiers

Uploaded Dossiers

GLOBAL SALES (USD Million)

U.S. Medicaid

0

Annual Reports

0

EXCIPIENTS

0

PATENTS & EXCLUSIVITIES

USFDA Orange Book Patents

0

USFDA Exclusivities

0

DIGITAL CONTENT

Blog #PharmaFlow

0

News

REF STANDARD

EDQM

USP

0

JP

0

Other Listed Suppliers

0

SERVICES

0

Looking for 60282-87-3 / Gestodene API manufacturers, exporters & distributors?

Gestodene manufacturers, exporters & distributors 1

36

PharmaCompass offers a list of Gestodene 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 Gestodene manufacturer or Gestodene supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Gestodene manufacturer or Gestodene supplier.

PharmaCompass also assists you with knowing the Gestodene API Price utilized in the formulation of products. Gestodene API Price is not always fixed or binding as the Gestodene Price is obtained through a variety of data sources. The Gestodene Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Gestodene

Synonyms

60282-87-3, Gestoden, Gestodenum [inn-latin], Gestodeno [inn-spanish], Sh b 331, Sh-b-331

Cas Number

60282-87-3

Unique Ingredient Identifier (UNII)

1664P6E6MI

About Gestodene

Gestodene is a progestogen hormonal contraceptive. Products containing gestoden include Meliane, which contains 20 mcg of ethinylestradiol and 75 mcg of gestodene; and Gynera, which contains 30 mcg of ethinylestradiol and 75 mcg of gestodene.

Gestodene Manufacturers

A Gestodene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gestodene, including repackagers and relabelers. The FDA regulates Gestodene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gestodene 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 Gestodene manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Gestodene Suppliers

A Gestodene supplier is an individual or a company that provides Gestodene active pharmaceutical ingredient (API) or Gestodene finished formulations upon request. The Gestodene suppliers may include Gestodene API manufacturers, exporters, distributors and traders.

click here to find a list of Gestodene suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Gestodene USDMF

A Gestodene DMF (Drug Master File) is a document detailing the whole manufacturing process of Gestodene active pharmaceutical ingredient (API) in detail. Different forms of Gestodene DMFs exist exist since differing nations have different regulations, such as Gestodene USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Gestodene DMF submitted to regulatory agencies in the US is known as a USDMF. Gestodene USDMF includes data on Gestodene's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gestodene USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Gestodene suppliers with USDMF on PharmaCompass.

Gestodene CEP

A Gestodene CEP of the European Pharmacopoeia monograph is often referred to as a Gestodene Certificate of Suitability (COS). The purpose of a Gestodene CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Gestodene EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Gestodene to their clients by showing that a Gestodene CEP has been issued for it. The manufacturer submits a Gestodene CEP (COS) as part of the market authorization procedure, and it takes on the role of a Gestodene CEP holder for the record. Additionally, the data presented in the Gestodene CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Gestodene DMF.

A Gestodene CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Gestodene 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 Gestodene suppliers with CEP (COS) on PharmaCompass.

Gestodene NDC

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 Gestodene as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Gestodene API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Gestodene 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Gestodene and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Gestodene NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Gestodene suppliers with NDC on PharmaCompass.

Gestodene GMP

Gestodene 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 Gestodene 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 Gestodene GMP manufacturer or Gestodene GMP API supplier for your needs.

Gestodene CoA

A Gestodene CoA (Certificate of Analysis) is a formal document that attests to Gestodene's compliance with Gestodene specifications and serves as a tool for batch-level quality control.

Gestodene CoA mostly includes findings from lab analyses of a specific batch. For each Gestodene 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.

Gestodene may be tested according to a variety of international standards, such as European Pharmacopoeia (Gestodene EP), Gestodene JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Gestodene USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
Ask Us for Pharmaceutical Supplier and Partner
Ask Us, Find A Supplier / Partner
No Commissions, No Strings Attached, Get Connected for FREE

What are you looking for?

How can we help you?

The request can't be empty

Please read our Privacy Policy carefully

You must agree to the privacy policy

The name can't be empty
The company can't be empty.
The email can't be empty Please enter a valid email.
The mobile can't be empty
Post Enquiry
POST ENQUIRY