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    Overview of GMP manufacturing & more on leading contract manufacturing organizations (CMOs) offering cGMP contract manufacturing services for APIs.

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    Overview of GMP manufacturing & more on leading contract manufacturing organizations (CMOs) offering cGMP contract manufacturing services for APIs.

    Q1 What is GMP and what is the importance of GMP manufacturing?

    GMP refers to the good manufacturing practice regulations propagated by the US Food and Drug Administration (USFDA) under the authority of the Federal Food, Drug, and Cosmetic Act. These regulations are required to conform to the guidelines recommended by the agencies that control the authorization of the manufacture, sale and licensing of pharmaceutical products, food and beverages, and cosmetics. Different countries have different agencies which regulate pharmaceutical manufacturing activities. 

    GMP thus constitutes the license to operate in pharmaceutical manufacturing and is a core condition worldwide. Moreover, this system is designed to minimize the risks involved in pharmaceutical production that cannot be eliminated by testing the final product. The main risks are unexpected contamination of products, causing damage to health or even death, incorrect labels on containers, and insufficient or excessive active ingredients, resulting in ineffective treatment. 

    cGMP refers to the current Good Manufacturing Practice regulations enforced by the FDA. Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGMP) are, in most cases, interchangeable, but the “c” in cGMP is added to certify that every step used in the pharmaceutical production process is not only done under the guidelines of GMP, but is also completed in the most current manner available.


    Importance of Good Manufacturing Practice (GMP): 

    It is nearly impossible to determine if a drug or supplement is safe or effective simply by looking at it. This is why GMP is so necessary — GMP guidelines protect consumers from potentially harmful medicines and supplements that they cannot detect themselves. Good Manufacturing Practice (GMP) guidelines aid manufacturers in improving the production of goods. 

    Furthermore, GMP guidelines help ensure proper design, monitoring, and control of manufacturing processes and facilities. GMP thus comes with strict protocols that lessen the risk of manufacturing errors. The FDA sets the current Good Manufacturing Practices (cGMP), a set of standards that cGMP manufacturers are required to follow and adhere to. These standards and guidelines also ultimately help in maintaining the trust of consumers. 

    Various pharmaceutical GMP manufacturing organizations, including contract cGMP manufacturers/companies (CMO), facilitate the outsourcing of GMP contract manufacturing services. Contract manufacturers may provide pharmaceutical GMP manufacturing services for APIs and key intermediates and other commercial pharmaceutical products to ensure that products fulfill GMP requirements. 

    The formulation development team and commercial manufacturing units of cGMP manufacturers work together to optimize formulations. cGMP manufacturers may also offer services to scale up from R&D to cGMP manufacturing of clinical trial materials and commercial pharmaceutical products.

    Q2 What are the principles of GMP Manufacturing?

    GMP guidelines are created and enforced by national or international regulatory agencies, like the USFDA or the World Health Organization (WHO) in order to protect consumers. GMP production takes into account five key elements, popularly known as the 5 P's of GMP - people, premises, processes, products, and procedures. 

    For pharmaceutical and other life science disciplines, it is important to focus on GMP compliance to ensure the best quality, consistency, and safety of end products for which the ‘5 principles of GMP manufacturing’, noted below, can be helpful. 


    5 Principles of GMP Manufacturing:

    People

    A pharmaceutical GMP manufacturing company is nothing without the people that run its activities. Employees must be trained to follow standard procedures and their performances must be assessed regularly to ensure all employees comply with the current good manufacturing practices that meet an organization's expected standards.

    Premises

    cGMP facilities should have well-documented cleaning procedures for all their premises and different types of equipment. It is also essential for them to have documented instructions on how to calibrate various equipment.

    Processes

    Processes should be appropriately documented in a clear and consistent manner, and should be distributed to all employees. Furthermore, processes where the output cannot be fully verified through subsequent monitoring or measuring should be validated. There should be complete documentation surrounding the validation activities as well.

    Products

    This “P” refers to the final products sold to consumers and the raw materials involved in the formulations. Specifications for raw materials (API and key intermediates) and components must be clear at every phase of cGMP manufacture, and there must be a record of the master formula. 

    Procedures

    All procedures must be regularly revisited to ensure the use of the latest technology and science involved in pharmaceutical GMP manufacturing. If a procedure is using outdated technology, the contract manufacturer may struggle to maintain current Good Manufacturing Practice (cGMP) compliance. Furthermore, the people employed in any manufacturing company must adhere to the rules and procedures for smoother functioning. 

    Q3 What are the key elements in GMP contract manufacturing?

    With the rise in US Food and Drug Administration (FDA) inspections, companies of all types are being audited for current Good Manufacturing Practice (cGMP) compliance, including companies which outsource all manufacturing, packaging, labeling, and holding activities to third parties. 

    In practice, personnel must be adequately trained, suitable premises and equipment used, correct materials used, approved procedures adopted, suitable storage and transport facilities available, and appropriate records made. The aspects noted below are considered key elements when it comes to pharmaceutical GMP contract manufacturing.


    Quality Management

    Quality management outlines the general concepts of quality assurance (QA) as well as the principal components or subsystems of GMP, which are the joint responsibilities of top management and of production and quality control management. Quality management focuses on the importance of building quality into products, by systematically controlling component and product-related processes. 

    Quality Control

    One of the most critical components of good manufacturing practice is quality control (QC). It can be defined as the process of sampling, testing, and comparing results with pre-agreed specifications as a part of the overall quality assurance (QA) process. 

    Personnel 

    There should be an adequate number of personnel qualified by appropriate education, training, and/or experience to perform and supervise the cGMP manufacture of API and key intermediates. 

    Contracts

    GMP contract manufacturing must be correctly defined. Written contracts must ensure satisfactory quantity and quality requirements.

    Documentation 

    All documents related to the cGMP manufacture of API and key intermediates should be prepared, reviewed, approved, and distributed according to written standard procedures.

    Premises & Equipment 

    Laboratories must maintain uniform premises and equipment. Equipment used in the cGMP manufacture of API and key intermediates should be of appropriate design and adequate size, and suitably located for its intended use. Furthermore, they should be cleaned, sanitized and maintained appropriately. 

    Self Inspection

    Audits are a way of inspecting systems to ensure that they are being carried out correctly when compared to pre-qualified ‘standards’.

    Production & Process Controls

    Companies must implement a system whereby they ensure products are produced, packaged, and labeled as per GMP compliance guidelines.

    Purchasing

    Purchasing includes parameters like specifications, quantities, and delivery times. Companies must verify these parameters related to the quality of incoming goods.

    Complaints & Recall

    Complaint records should include the name and address of the complainant, the phone number of the person submitting the complaint, the nature of the complaint (including name and batch number of the API), and the date when the complaint is received.


    cGMP manufacturers/companies (CMO) provide GMP contract manufacturing services which may help small and mid-sized pharmaceutical companies from drug development all the way through to drug manufacturing. In addition, some organizations offer formulation development and GMP production services for complex APIs and key intermediates. 

    Q 4 What are the advantages of working with an embedded CMO offering API GMP manufacturing services?

    To produce a drug, different kinds of resources are needed. A company may not find all of these resources in its own country and can outsource such cGMP manufacturing services to a country where these resources are readily available. Companies that outsource manufacturing can cut labor costs, including salaries for personnel, overhead, equipment, and technology.

    Pharma companies often need to access specialized GMP manufacturing resources, facilities, and capabilities to progress a drug from development to commercial production. Thus, pharmaceutical developers can bring a product to market in two ways: by manufacturing it in their own facilities; or by procuring and buying capacity from a contract manufacturing organization (CMO). 

    Currently, the outsourcing market is extremely fragmented – from smaller, specialized CMOs and full-service, end-to-end contract development and manufacturing organizations (CDMOs) to ‘pure play’ and embedded outsourcing models.

    Businesses operating as embedded contract manufacturing organizations (CMOs) are self-contained organizations that work within larger companies. They use all the assets and resources of a larger company to manufacture API and key intermediates and other pharmaceutical drug products for their partners. 


    Some Advantages of Working with an Embedded CMO Offering API GMP Manufacturing Services:

    Growth

    A capacity-filling-only model can be precarious for biopharmaceutical companies, which require a steady, long-term CMO partner. A primary advantage of an embedded contract manufacturing organization (CMO) is that it operates to a business model built to support strategic growth. 

    Quality Assurance

    Contract manufacturing organizations (CMOs) have pre-established quality checks in place that have been refined over the years. cGMP manufacturers have to ensure that they are manufacturing API and key intermediates in GMP compliance with various standards used in different countries.

    Global Network

    Working with an embedded contract manufacturing organization (CMOs) gives customers access to the people and advanced science that are used by the parent organization to bring innovative commercial drug products to market. 

    Direct Engagement for Long-term Planning

    A contract manufacturing organization (CMO) is an integral part of the organization’s operations team, giving it a direct line to key decision-makers within the wider organization. As a result, any issues are raised and dealt with readily, at a company-wide level when necessary.

    Scalability

    As a small business or start-up, it’s challenging to scale products with limited resources at hand. Since contract manufacturers have more resources, they are more than able to scale products.

    World-Class Operations and Sustained Investment

    An embedded CMO’s strategic value is also contingent on the quality of its facilities, and devotion to technical innovation. 


    A cGMP manufacturer may offer contract services in accordance with current Good Manufacturing Practice (cGMP) guidelines. Some contract development and manufacturing organizations (CDMOs) have several years of experience that have enabled them to gain niche expertise in drug manufacturing and formulation development, along with the expertise to scale up from R&D to cGMP manufacturing. In addition, contract cGMP manufacturers/companies (CMO) may offer a broad range of GMP production services for the pharmaceutical industry and ensure that all commercial pharmaceutical products comply with cGMP requirements.

    Q5 Which are the leading pharmaceutical companies offering GMP contract manufacturing for APIs?

    Various GMP contract manufacturers, including contract development and manufacturing organizations (CDMOs), may have experience in producing API and key intermediates and drug manufacturing. Such CMOs and CDMOs can offer cGMP manufacturing services for the biotechnology and pharmaceutical industry as per cGMP requirements.

    These organizations might have years of experience in developing commercial pharmaceutical products along with clinical trial materials via GMP manufacturing. Some of the top contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) with GMP contract manufacturing capabilities are explored below.


    Leading cGMP Manufacturers Offering GMP Contract Manufacturing Services:


    Interquim SA - GMP Manufacturing

    Interquim's quality system is governed by good manufacturing practices (GMP) and continual improvement. Their quality system and installations have been inspected and approved by regulatory bodies and clients, who demand the highest standards.


    PMC Isochem - GMP Manufacturing

    PMC Isochem operates 3 cGMP manufacturing sites for the production of API and key intermediates, excipients such as tocophersolan (Vitamin E TPGS), and amino acid polymers. PMC Isochem offers cGMP and non-cGMP industrial exclusive custom synthesis and provides tailor-made services, from development to production, including route selection, process and analytical development, clinical trial materials GMP manufacturing as well as process optimization.


    Pfizer CentreOne - cGMP API Manufacturing

    Pfizer's pilot cGMP manufacturing facility has the flexibility to support small clinical or commercial batches. They provide commercial manufacturing services for large biologic molecules, solid oral doses, and sterile injectables along with GMP manufacturing of clinical trial materials. Its manufacturing site in Kalamazoo focuses on producing API and key intermediates for branded medicines.


    Minakem - cGMP API Manufacturing

    Minakem's Beuvry-la-Forêt site has over 40 years of experience and expertise in fine organic and pharmaceutical chemistry, and offers cGMP manufacturing services for API and key intermediates, regulatory starting materials, and building blocks. They also provide commercial manufacturing services, including scale up from R&D to cGMP manufacturing.


    Farmak A.S - GMP Compliant Manufacturing

    Farmak offers production in GMP compliance with the current good manufacturing practice (cGMP) and ISO systems from several production modules. Their manufacturing facilities are capable of a batch size from 100 g up to several kilograms (kilo lab) and from 5 kg to 250 kg in reactors.

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    Farmak offers production in compliance with the cGMP and ISO systems of several production modules. Its API manufacturing facilities are capable of producing batches ranging from 100 g to several kilograms (Kilolab) and from 5 kg to 250 kg in reactors.

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    Axplora

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    cGMP API MANUFACTURING SERVICES

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    Axplora offers CDMO services for APIs and intermediates in compliance with cGMP manufacturing. Its API cGMP facilities are dedicated to the manufacturing, and scale-up of small-molecules, biomolecules, ADCs, and highly potent APIs.

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    Interquim SA

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    Interquim's quality system is governed by good manufacturing practices (GMP) and continual improvement. Its quality system and installations have been inspected and approved by regulatory bodies, who demand the highest standards.

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    Interquim GMP Manufacturing

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    Minakem

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    Minakem's Beuvry-la-Forêt site has over 40 years of experience and expertise in fine organic and pharmaceutical chemistry, offers cGMP manufacturing for APIs, advanced pharmaceutical intermediates, regulatory starting materials, and building blocks.

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    Polpharma

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    Polpharma API supports process development, scale-up, and cGMP manufacturing of small molecule APIs in volumes ranging from kilos to tens of tons. It has FDA approved GMP facilities from pilot plant scale to multi-ton manufacturing scale.

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    Biophore India Pharmaceuticals Pvt Ltd

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    GMP CERTIFIED FACILITY FOR API MANUFACTURING

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    Biophore's state-of-the-art, multipurpose manufacturing facilities comply with cGMP standards and meet the requirements of the US and EU drug regulatory authorities. It offers peptides, hormones, colored APIs, oncology drugs, etc.

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    Biophore GMP Certified Facility for API Manufacturing

    CPhI Worldwide, Milan

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    Inke S.A

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    Inke's API GMP manufacturing plant is focused on the development of products with complex synthesis and extremely high GMP requirements. It offers contract manufacturing for active pharmaceutical ingredients (APIs) in batches ranging from 1 kg to 300 kg.

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    Inke GMP API Manufacturing

    CPhI Worldwide, Milan

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    Bachem AG

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    GMP MANUFACTURING FOR PEPTIDE APIs

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    Bachem is a CDMO with its manufacturing facilities complying with Good Manufacturing Practice (GMP) standards of regulatory agencies, such as the Food and Drug Administration (FDA) and the Swissmedic (Switzerland).

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    Evonik

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    Evonik's sites across Europe, the US and Asia are equipped with some of the most advanced facilities in the CMO industry for the GMP manufacturing of active pharmaceutical ingredients (APIs) utilizing either batch or continuous processes.

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    Fermion Oy

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    GMP MANUFACTURING FOR APIs

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    Fermion is a CDMO which has a bench scale unit fully automated and equipped with high containment processing technology. The unit manufactures APIs as per cGMP guidelines and has technical capabilities that include 10-30 L reactors.

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    LEBSA

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    Lebsa’s GMP pilot plant is one of the first to be run by a manufacturer of active pharmaceutical ingredients in Spain. The plant is fully automated and develops APIs in a scalable, secure and environmentally friendly way for the third parties.

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    Seqens

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    Seqens conducts GMP manufacturing of APIs from kilo to pilot scale to commercial multi-ton quantities. It has 8 cGMP and FDA-inspected plants in Europe, the US, Israel & India for commercial production.

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    Suanfarma CDMO

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      Suanfarma CDMO is your strategic partner with more than 2000 m3 of fermentation capabilities and 800m3 of chemical synthesis reaction capacities, with different scales and volumes to accommodate batch size requirements.

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      Suanfarma API GMP Manufacturing

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      CBL- Chemical and Biopharmaceutical Laboratories

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      GMP MANUFACTURING OF PEPTIDES

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      CBL is one of the largest peptide material suppliers in the world, offering peptide starting materials, peptide intermediates and commercial-scale manufacturing of proprietary and generic GMP and non-GMP peptides.

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      CBL- Chemical and Biopharmaceutical GMP Manufacturing of Peptides

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      Egis Pharmaceuticals PLC

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      Egis Pharmaceuticals offers the manufacturing of active pharmaceutical ingredients and intermediates with organic chemical synthesis on a large-scale under cGMP regulations. It also has highly potent GMP lines for the production of HPAPIs.

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      Extrovis AG

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        Extrovis has state-of-the-art GMP manufacturing and R&D facilities for APIs that comply with the highest international quality standards with accreditations from the USFDA, PMDA, EU, and other global regulatory bodies.

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        Extrovis API GMP Manufacturing

        Arab Pharma Expo 2024

        Not Confirmed

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        Gentec Pharmaceutical Group

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        GMP MANUFACTURING FOR APIs & HPAPIs

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        Gentec offers contract manufacturing of active pharmaceutical ingredients (APIs) as well as advanced intermediates and fine chemicals in its plant, Duke Chem which is cGMP compliant.

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        Pharma Service: API Manufacturing

        Category: GMP Manufacturing

        Sub Category: Active Pharmaceutical Ingredients

        GMP Manufacturing for APIs & HPAPIs

        CPhI Worldwide, Milan

        Exhibiting

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        Laboratorium Ofichem B.V

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        Virtual BoothLaboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.
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        API GMP MANUFACTURING

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        Laboratory Ofichem is a modern API producer located in the Netherlands and has 15 production facilities. It follows the current Good Manufacturing Practice (cGMP) guidelines & applies the highest safety standards to avoid the risk of cross-contamination.

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        Laboratorium Ofichem API GMP Manufacturing

        CRS 2024

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        Malladi Drugs & Pharmaceuticals Limited

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        Virtual BoothMalladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
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        API GMP MANUFACTURING

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        Malladi provides reliable GMP manufacturing capabilities for the production of a wide range of APIs and intermediates. Its GMP compliant manufacturing facilities are state-of-the-art facilities approved by the USFDA.

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        Pharma Service: API Manufacturing

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        Malladi Drugs API GMP Manufacturing

        Arab Pharma Expo 2024

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        CSBio

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          cGMP PEPTIDE MANUFACTURING

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          CSBio has been involved in the production of cGMP peptides for over 15 years. It has specialized state-of-the-art facilities for peptide manufacturing for toxicological studies, Phase I, Phase II, and Phase III clinical trials worldwide.

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          CSBio cGMP Peptide Manufacturing

          TIDES Europe 2024

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          ICE Pharma

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          Virtual BoothICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
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          cGMP MANUFACTURING FOR CARBOHYDRATES

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          ICE is a pharmaceutical contract development and manufacturing service provider for complex carbohydrates. It offers full cGMP manufacturing of carbohydrates to support phase 1 and phase 2 clinical trials.

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          Pharma Service: API Manufacturing

          Category: GMP Manufacturing

          Sub Category: Overview

          cGMP Manufacturing for Carbohydrates

          CPhI Worldwide, Milan

          Booth #4A41

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          M2i Group

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          Virtual BoothM2i Group, an integrated CDMO, is your French partner for development & manufacturing in fine chemistry.
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          GMP API MANUFACTURING

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          M2i's Pharma & Chemical division is dedicated to the research, development and production of active ingredients, synthetic intermediates and pheromones on behalf of various industries and in compliance with good manufacturing practices (GMP).

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          Pharma Service: API Manufacturing

          Category: GMP Manufacturing

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          M2i Group GMP API manufacturing

          CPhI Worldwide, Milan

          Booth #4B109

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          Neuland Laboratories

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          Virtual BoothNeuland Laboratories- A dedicated 100% API provider.
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          cGMP API MANUFACTURING

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          Neuland is at the forefront of facilitating and accelerating drug development and commercial cGMP manufacturing of APIs. The company’s technical and scientific teams provide reliable solutions and services to the global pharmaceutical industry.

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          Pharma Service: API Manufacturing

          Category: GMP Manufacturing

          Sub Category: Overview

          cGMP API Manufacturing

          Peptide Therapeutics

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          Quotient Sciences

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          Virtual BoothQuotient Sciences- Molecule to Cure. Fast.
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          GMP DRUG SUBSTANCE MANUFACTURING

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          Quotient Sciences has facilities that can provide both GMP and non-GMP drug substance manufacturing with the ability to generate quantities in kg per day. Its capability includes 5L GMP and non-GMP process chemistry facilities with full thermal control.

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          Category: GMP Manufacturing

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          GMP Drug Substance Manufacturing

          ChemOutsourcing

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          USV Private Limited

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          Virtual BoothUSV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.
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          CONTRACT MANUFACTURING FOR GMP PEPTIDES

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          USV's state-of-the-art R&D laboratory and US-FDA-approved manufacturing facilities offer full services in peptide manufacturing from research to commercial scale. It has a dedicated facility for the bulk manufacturing of GMP-grade peptides.

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          Pharma Service: API Manufacturing

          Category: GMP Manufacturing

          Sub Category: Overview

          Contract Manufacturing for GMP Peptides

          CPhI Worldwide, Milan

          Booth #10F41

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          Pfizer CentreOne

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          Virtual BoothPfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
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          cGMP API MANUFACTURING

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          Pfizer's pilot cGMP manufacturing facility has the flexibility to support small clinical or commercial batches as well as scale to commercial volumes. Its manufacturing site in Kalamazoo focuses on the GMP production of APIs and intermediates.

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          Pharma Service: API Manufacturing

          Category: GMP Manufacturing

          Sub Category: Overview

          cGMP API Manufacturing

          Contract Pharma 2024

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          Farmhispania

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          Virtual BoothFarmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
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          cGMP API MANUFACTURING

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          Farmhispania has FDA-inspected cGMP contract manufacturing sites for APIs, highly potent APIs & cytotoxic APIs. It is also involved in the clinical GMP manufacturing of APIs in g & kg scale for phase 1 & 2a and kg & multi-ton quantities for phase 2b & 3.

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          Pharma Service: API Manufacturing

          Category: GMP Manufacturing

          Sub Category: Overview

          cGMP API Manufacturing

          CPhI Worldwide, Milan

          Booth #1B71

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          Pfanstiehl

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          cGMP API MANUFACTURING

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          Pfanstiehl provides services from process development to commercialization of cGMP APIs and high potency APIs. It has a dedicated facility for bulk cGMP production of active pharmaceutical ingredients from kilogram to multi-metric ton quantities.

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          Pharma Service: API Manufacturing

          Category: GMP Manufacturing

          Sub Category: Active Pharmaceutical Ingredients

          cGMP API Manufacturing

          DDF Summit, US

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          Anhui Ribobay Pharmaceutical

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            cGMP OLIGONUCLEOTIDE API MANUFACTURING

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            Ribobay offers GMP-grade oligonucleotide API production services across all stages of drug development. Its manufacturing facilities can meet cGMP requirements and can produce hundreds of kilograms of GMP-grade oligonucleotides annually.

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            Pharma Service: API Manufacturing

            Category: GMP Manufacturing

            Sub Category: Overview

            cGMP Oligonucleotide API Manufacturing

            Arab Pharma Expo 2024

            Not Confirmed

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            Indar

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            GMP STANDARDS ARE ADOPTED FOR BEST MANUFACTURING

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            Indar is equiped with modern technological infrastructure of sites and IT-technologies allow managing manufacturing processes, accomplishing constant control of product quality & achieving maximum purity of insulin substance and producing medications of the highest quality.

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            Category: GMP Manufacturing

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            Laboratoires Gilbert

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              GOOD MANUFACTURING METHODS

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              Good Manufacturing Methods for the manufacture of market-approved medicines.

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              HEBEI CHANGSHAN BIOCHEMICAL PHARMACEUTICAL CO., LTD.

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              R & D, PRODUCING & SALE OF HEPARIN PRODUCTS

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              Changshan Pharm has been endeavored in the researching & developing, producing and sale of heparin products and gradually led around China in heparin API and preparation.

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              CTX Lifesciences

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              GMP MANUFACTURING FOR APIs & INTERMEDIATES

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              CTX Life Sciences offers GMP contract manufacturing services for APIs and intermediates. Its manufacturing blocks have quality by design air-handling units as per cGMP requirements.

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              Alven Laboratories

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              cGMP COMPLIANT API CONTRACT MANUFACTURING

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              Alven operates a completely new state-of-the-art, cGMP compliant API manufacturing facility. All GMP production activities are carried out with aim to further improvement, protect the environment, optimize technology, etc.

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              Pharma Service: API Manufacturing

              Category: GMP Manufacturing

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              Kimia Biosciences

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                API GMP MANUFACTURING SERVICES

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                Kimia Biosciences covers the entire life cycle of a new chemical entity at all scales, from pre-clinical & clinical phases to validation & commercial supply, while fully complying with cGMP regulations & standards within WHO GMP, FDA approved facilities.

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                Shanghai Chemspec Corporation

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                APIs & ADVANCED INTERMEDIATES

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                Chemspec possesses one FDA-inspected GMP site in NJ, USA & two GMP workshops in its Shanghai site, which provide contract manufacture services for APIs and advanced intermediates. There custom manufacturing encompasses everything from advanced intermediates to highly complex components.

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                Mac-Chem Products (India) Pvt.Ltd

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                GMP MANUFACTURING

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                Mac-Chem has a cGMP compliant manufacturing facility at Boisar with more than 100 API manufacturing plants. It has capabilities for manufacturing oncology APIs, general and bulk sterile APIs.

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                Avara Pharmaceutical Services

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                  cGMP PRODUCTION OF APIs

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                  Two of Avara’s sites provide contract development and manufacturing of active pharmaceutical ingredients (API). All facilities worldwide have a long-term record of quality and regulatory compliance.

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                  BioSpectra

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                  GMP MANUFACTURING

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                  BioSpectra offers a range of custom GMP contract products & services manufactured exclusively in our state-of-the-art, FDA registered and inspected GMP facility in Bangor PA, USA.

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                  Pharma Service: API Manufacturing

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                  Anthem Biosciences

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                  GMP MANUFACTURING

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                  Anthem Biosciences offers manufacturing of molecules from early phase to commercial supplies. It provides GMP and non-GMP manufacturing for APIs with process validation and scale up from mg to ton.

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                  CRMO Pharmmatecch

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                    GMP MANUFACTURING CONSULTING

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                    CRMO offers consulting services covering Current Good Manufacturing Practices(cGMP), Quality Management including all aspects of Good Laboratory Practice(GLP), Validation and Qualification as well Regulatory agency Documentation.

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                    Cook Pharmica LLC.

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                    COMMERCIAL cGMP PRODUCTION

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                    Cook Pharmica is a leading contract development and manufacturing organization (CDMO) centrally located in Bloomington, Indiana. From the beginning, Cook Pharmica set out to build a CDMO that would meet and exceed the expectations of the biopharmaceutical industry.

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                    Infinium Pharmachem

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                      GMP COMPLIANT MANUFACTURING

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                      Infinium provides custom manufacturing services for Iodine Derivatives & APIs under GMP standards. Our manufacturing and testing facilities are GMP compliant. We have extensive experience in process development, analytical method validation and process validation under GMP regulations.

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                      Nanjing Dorra Pharmaceutical Technology Co.,Ltd

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                        GMP COMPLIANT MANUFACTURING

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                        - Service Details

                        Dorrapharma is engaged in R&D, manufacture and market of intermediate, API (Active Pharmaceutical Ingredients) and formulation. We stick to raise the value both for the company and customer, and strive for serving for the society and caring of the others.

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                        AmbioPharm

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                        GMP MANUFACTURING FOR PEPTIDES

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                        AmbioPharm offers GMP manufacturing for peptides using liquid phase, solid phase or hybrid processes. It has experience in peptide process development, scale up, and cGMP (current good manufacturing practice) production.

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                        Flamma SpA

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                        cGMP MANUFACTURING

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                        When you consider where to have your cGMP materials made, there are many choices to go along with many questions you may have. Flamma is a flexible organization that is fully integrated. The ability to provide a reliable supply chain for the necessary raw materials and advanced intermediates

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                        ScinoPharm Taiwan, Ltd

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                        cGMP API MANUFACTURING

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                        ScinoPharm offers a wide array of process R&D services & API manufacturing capabilities designed to satisfy customers' exact requirements & facilitate their rapid market introductions. ScinoPharm specializes in process R&D & the production of cGMP APIs.

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                        DOTTIKON EXCLUSIVE SYNTHESIS AG

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                        QUALITY MANAGEMENT

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                        cGMP and other higher industry quality standards are an integral part of the comprehensive quality system of DOTTIKON EXCLUSIVE SYNTHESIS AG's independent Quality Management department.

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                        Olon S.p.A

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                        cGMP MANUFACTURING

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                        - Service Details

                        Our site has production areas dedicated for pharmaceutical manufacturing. These areas (classified environments in downstream process area) comply with cGMP requirements (ISO). United States and European authorities (FDA, AIFA) as well as customers on rout

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                        Hameln rds

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                        GMP MANUFACTURING OF APIs

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                        Hameln rds offers services including development and GMP manufacturing of active pharmaceutical ingredients (APIs), intermediates and high potency APIs.

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                        Dr Pradeep Reddy’s Laboratories Private Limited

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                          GOOD MANUFACTURING PRACTICE (GMP) STANDARDS.

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                          We pride ourselves on outstanding quality to ensure consistently high demand for our products. Using GMP sources of raw materials, goods are manufactured to Good Manufacturing Practice (GMP) standards.

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                          Magle Chemoswed

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                          PILOT PLANT MULTI KILOGRAM GMP SYNTHESIS

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                          Our pilot plant is a multi-purpose plant and runs according to cGMP.

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                          Bioindustria L.I.M. Spa

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                          GMP CERTIFIED API MANUFACTURING

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                          Biondustria L.I.M's Quality System has been recognised by the FDA approval and AIFA.

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                          CLEARSYNTH LABS LIMITED

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                            BOTH cGMP & NON-GMP SYNTHESIS

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                            CLEARSYNTH efforts focus from the pre-clinical stage through to phase III and to the successful technology transfer to manufacturing locations throughout the world.

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                            Sai Life Sciences Limited

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                            GMP MANUFACTURING

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                            Sai Life Sciences provides GMP Active Pharmaceutical Ingredients (APIs) and intermediates for late clinical phase and commercial New Chemical Entities for US, European and Japanese innovators.

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                            Cerbios-Pharma SA

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                            API GMP MANUFACTURING

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                            Cerbios is a highly qualified contract development and manufacturing organization (CDMO) engaged in development and cGMP manufacturing of APIs, HPAPIs, ADCs and biologics.

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                            UQUIFA

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                            GMP COMPLIANT MANUFACTURING

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                            Uquifa is a leading company for API and advanced intermediate development and manufacturing. They can offer R&D and cGMP compliant manufacturing across two continents, America and Europe.

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                            Kekule Pharma

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                            GMP MANUFACTURING FOR APIs

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                            Kekule has developed from a contract manufacturer of a few molecules to a preferred vendor for many complex molecules requiring multistage synthesis. It offers services including commercial GMP manufacturing of APIs, contract manufacturing, scale-up, etc.

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                            Prague Scientific

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                            GMP OPERATIONS FOR COMMERCIAL MANUFACTURING

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                            Prague Scientific offers process development & GMP operations with optimization of chemical reaction parameters utilizing DoE & QbD principles, as well as process validation of development APIs for clinical trials & commercial supply.

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                            ChemCon GmbH

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                            API GMP MANUFACTURING

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                            ChemCon is a CDMO offering high-quality GMP manufacturing services in gram to multi-kilogram batches. It offers GMP-compliant manufacturing for the production of high-quality fine chemicals and APIs.

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                            Anacipher

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                              GMP FOR INTERMEDIATE & API

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                              Indoco Kilo Lab is a modern, state-of-the-art facility with all Equipments conforming to cGMP and GEP norms. Design to meet cGMP, EDQM and USFDA standards

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                              KriSan Biotech

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                                cGMP API MANUFACTURING

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                                KriSan Biotech provides world-class services to support cGMP production of active pharmaceutical ingredients (APIs) with an experience of more than 15 years. It offers cGMP manufacturing for small molecules, peptide-drug conjugates and oligonucleotides.

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                                Saneca Pharmaceuticals

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                                CONTRACT API MANUFACTURING

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                                Saneca Pharma has over 70 years’ experience in manufacturing active pharmaceutical ingredients (API’s) .Saneca Pharma is a CDMO partner that can add value to your project.

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                                Recipharm AB

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                                GMP MANUFACTURING SERVICES

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                                Recipharm is a GMP manufacturing organization that offers contract manufacturing services for several API products, including generic & hormonal APIs. The facility is equipped to handle high pressure, high temperature & low temperature reactions.

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                                Menadiona

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                                GMP COMPLIANT API MANUFACTURING

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                                Menadiona's two manufacturing plants are equipped with modern GMP production facilities for both liquid and solid products. The manufacturing operations are carried out according to the current good manufacturing practices (GMP) and environmental laws.

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                                Angelini Pharma

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                                cGMP MANUFACTURING

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                                Angelini's manufacturing unit is equipped with technologies and primary containment options with engineering controls to meet cGMP pilot batches for process scale-up and development, start-up batches, and full-scale cGMP manufacturing.

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                                Maithili Life Sciences

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                                  cGMP FACILITY

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                                  Our cGMP facility closes the chain of services from route scouting through to commercial manufacturing.

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                                  Dishman Carbogen Amcis

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                                  cGMP MANUFACTURING

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                                  Dishman is committed to current Good Manufacturing Practices (cGMP) procedures and ensure that our global manufacturing sites adhere fully to our internal GMP policies, local regulations and the international guidelines associated with the USFDA

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                                  Procos

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                                  cGMP & AIFA COMPLIANT MANUFACTURING

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                                  Our fully equipped, cGMP and AIFA inspected facility covers an area of more than 100,000 sq. meters and enables API production on any scale, even according to complex syntheses.

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                                  Piramal Pharma Solutions

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                                  GMP API CONTRACT MANUFACTURING

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                                  Piramal manufactures & supplies APIs through its sites in North America, Europe & Asia. Its API sites have been inspected & approved by several global regulatory bodies like, the US FDA, Japan PMDA & UK MHRA, and they meet the cGMP compliance standards.

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                                  Curia

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                                  cGMP API MANUFACTURING

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                                  Curia provides scientific expertise and state-of-the-art technologies to support the chemical development and cGMP manufacturing of complex APIs, including generics, potent and cytotoxic compounds, sterile APIs, steroids and controlled substances.

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                                  Quality Chemicals

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                                  cGMP PRODUCTION FACILITIES

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                                  Quality Chemicals is a European manufacturer of high-purity salts. They have two production plants, one in Esparreguera and another in Venta de Baños, Palencia where they have GMP facilities for manufacturing inorganic salts.

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                                  DrugOn Pharma Switzerland

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                                    GMP COMPLIANT MANUFACTURING OF APIs

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                                    Drug’On Pharma Switzerland was the last company to be set up in the Orofino Pharmaceuticals Group. The chemical manufacturing site produces active pharmaceutical ingredients (API) and intermediates.

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                                    Diverchim S.A.

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                                    AN ADAPTABLE cGMP OFFER

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                                    Diverchim offers specific and dedicated services in regards to the status of your project. This allows a full tracability if needed, depending on your quality and regulatory requirements.

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                                    CARBOGEN AMCIS AG

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                                    cGMP COMPLIANT API MANUFACTURING SERVICE PROVIDER

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                                    Dishman facilities operate to current Good Manufacturing Practice (cGMP) and can produce material for preclinical testing, clinical trials and commercial use. Our manufacturing sites are regularly inspected by the US Food and/or Drug Administration (FDA) and local regulatory bodies.

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                                    PHYTOPHARM KLEKA S.A

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                                      GMP CERTIFIED PRODUCTION

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                                      Phytopharm use cutting-edge technologies and equipment to produce extracts from fresh and dried plants. We are GMP Certified.

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                                      Concord Biotech

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                                      GMP MANUFACTURING

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                                      Our API manufacturing facility is focused on manufacturing semi-synthetic based API’s with fermentation capacity of more than 500m3. The site practices cGMP and inspected by global regulatory agencies like USFDA, EUGMP, Japanese AFM, and Indian State GMP.

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                                      Onyx Scientific

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                                        PHASE I-III GMP MANUFACTURING

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                                        Onyx Scientific's Phase I-III small molecule API development and manufacturing services support through each preclinical research stage. It offers GMP manufacturing along with analytical method development and stability testing.

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                                        SIMS Srl

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                                        GMP MANUFACTURING

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                                        The GMP operating pilot is equipped with a double enamel line (up to 800 lt) and a steel line (up to 1000 lt), two centrifuges and rectification capacity (stainless steel) in full and in vacuum.

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                                        Grace

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                                          cGMP MANUFACTURING

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                                          Grace Albany's facilities and quality systems have been audited and qualified for cGMP manufacture and hold ISO9001 certification.

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                                          Aragen Life Sciences

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                                          GMP MANUFACTURING

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                                          GVK BIO manufacturing facility at Vizag has two GMP Production Blocks: Reaction volume of 87 Kilo Litres (m3)

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                                          GBI

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                                            cGMP CLINICAL & COMMERCIAL MANUFACTURING

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                                            Multiple bioreactor platforms and scales for a variety of production modalities including batch, fed batch and perfusion. End to end manufacturing from creation of drug substance to drug product including mAbs, vaccines & ADCs.

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                                            Grunenthal

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                                            GMP CERTIFIED MANUFACTURING

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                                            Grunenthal is a contract manufacturing organization (CMO) that offers GMP production from APIs all the way up to finished products with a strong service portfolio including development, release, warehousing and distribution.

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                                            Huvepharma Italia S.r.l

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                                              GMP MANUFACTURING

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                                              Huvepharma® Italia is a recognized as a reliable supplier of development and manufacturing services of APIs & advanced intermediates for leaders in the international market.

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                                              Biovian

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                                                MANUFACTURING OF BIOPHARMACEUTICALS

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                                                Biovian is a one-stop-shop in GMP contract manufacturing of biopharmaceuticals covering services from early development to finished vial. Biovian's 2700 m2 facilities are EMA certified and FDA inspected for cGMP production of investigational and commercial products.

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                                                Aesica Pharmaceuticals Limited

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                                                FIVE cGMP MANUFACTURING PLANTS

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                                                Aesica has over 30 years’ experience in API development, manufacturing and generic supply. We have five cGMP manufacturing plants dedicated to the commercial-scale production of APIs

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                                                Pharma Service: API Manufacturing

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                                                Solvias

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                                                Solvias offers GMP manufacturing from preclinical support to clinical trials I, II or III and has proven manufacturing and development expertise including API synthesis up to multi kg scale under GMP as well as non GMP.

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                                                Siegfried AG

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                                                IDEAL PARTNER FOR cGMP API & INTERMEDIATE MANUFACTURING

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                                                Compliance is our commitment. Expect more with Siegfried as your preferred partner as we are committed to continuous accountable improvement and quality-centered management of all company processes and activities. The quality policy within Siegfried forms an integral part of our overall company

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                                                Evotec

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                                                Evotec's integreated CMC capabilities include: API polymorph screening, salt-selection, co-crystals screening, API route scouting, process development and scale-up, API GMP manufacturing, Solid state characterization.

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                                                Bellen Chemistry

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                                                  cGMP API MANUFACTURING

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                                                  Bellen manufacturing plant at shandong, delivers cGMP APIs & key intermediates manufacturing services for early phase and late phase projects. The facility has a capacity of 100KL with manufacturing blocks into groups to achieve maximum flexibility.

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                                                  Pharma Service: API Manufacturing

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                                                  Sub Category: Active Pharmaceutical Ingredients
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                                                  Ardena

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                                                    API GMP MANUFACTURING SERVICES

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                                                    Ardena offers GMP manufacturing service with equipments consists of reactors from 1L up to 1000L (HC and GLS), autoclave reactors, liquid, slurry, and powder dosing devices, agitated work up tanks (700 L), filters, filter dryers, etc.

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                                                    DPT Laboratories, Ltd

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                                                    At our Center of Excellence for Semi-solids and Liquids in San Antonio, 400 professionals provide cGMP manufacturing support for drugs at pilot, clinical and commercial scales.

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