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  • INJECTABLE;INJECTION - EQ 100MG BASE/VIAL
  • CAPSULE;ORAL - EQ 100MG BASE
  • CAPSULE;ORAL - EQ 50MG BASE
  • CAPSULE;ORAL - EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, EXTENDED RELEASE;ORAL - EQ 105MG BASE
  • TABLET, EXTENDED RELEASE;ORAL - EQ 115MG BASE
  • TABLET, EXTENDED RELEASE;ORAL - EQ 135MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, EXTENDED RELEASE;ORAL - EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, EXTENDED RELEASE;ORAL - EQ 55MG BASE
  • TABLET, EXTENDED RELEASE;ORAL - EQ 65MG BASE
  • TABLET, EXTENDED RELEASE;ORAL - EQ 80MG BASE
  • TABLET, EXTENDED RELEASE;ORAL - EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Looking for 13614-98-7 / Minocycline Hydrochloride API manufacturers, exporters & distributors?

Minocycline Hydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Minocycline Hydrochloride

Synonyms

13614-98-7, Minocycline hcl, Arestin, Solodyn, Minomycin, Minocin

Cas Number

13614-98-7

Unique Ingredient Identifier (UNII)

0020414E5U

About Minocycline Hydrochloride

A TETRACYCLINE analog, having a 7-dimethylamino and lacking the 5 methyl and hydroxyl groups, which is effective against tetracycline-resistant STAPHYLOCOCCUS infections.

Minocycline Manufacturers

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

Minocycline Suppliers

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

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

Minocycline USDMF

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

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

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

Minocycline JDMF

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 Minocycline Drug Master File in Japan (Minocycline JDMF) empowers Minocycline 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 Minocycline JDMF during the approval evaluation for pharmaceutical products. At the time of Minocycline 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 Minocycline suppliers with JDMF on PharmaCompass.

Minocycline KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Minocycline Drug Master File in Korea (Minocycline KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Minocycline. The MFDS reviews the Minocycline KDMF as part of the drug registration process and uses the information provided in the Minocycline KDMF to evaluate the safety and efficacy of the drug.

After submitting a Minocycline 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 Minocycline API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Minocycline suppliers with KDMF on PharmaCompass.

Minocycline CEP

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

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

Minocycline 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 Minocycline as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Minocycline 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 Minocycline 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 Minocycline and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Minocycline NDC to their finished compounded human drug products, they may choose to do so.

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

Minocycline GMP

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

Minocycline CoA

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

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

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