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Manufacturing Active Pharmaceutical Ingredients (API)

Find innovative production technology for making active pharmaceutical ingredients (api) and connect directly with world-leading specialists.

Making active pharmaceutical ingredients

API making equipment must observe rigorous quality control standards across the entire manufacturing process. The pharmacodynamic properties of active pharmaceutical ingredients API make them highly sensitive to their environment, making API manufacturing and production a tightly regulated field.

Which active pharmaceutical ingredients (api) technology do you need?

GMP dispersing machine for liquid formulations

GMP dispersing machine for liquid formulations

Multi-staged rotor/stator mixers generate the high shear forces required to …

Industrial sieving machine for pharmaceuticals

Industrial sieving machine for pharmaceuticals

One of the physical attributes that granular pharmaceutical products must ha…

Fluidized bed system for the granulation and drying of pharmaceuticals

Fluidized bed system for the granulation and drying of pharmaceuticals

Pharmaceutical industries employ several processe…

Continuous roller compactor for dry granulation of pharmaceuticals

Continuous roller compactor for dry granulation of pharmaceuticals

When making tablets, pharmaceutical manufacturers nee…

Container blender for pharmaceuticals

Container blender for pharmaceuticals

Manufacturing pharmaceutical solids like tablets requires using a proper blender to bl…

Pharmaceutical tablet coating machine

Pharmaceutical tablet coating machine

Tablet coating requires spraying, mixing, and drying procedures that must be carried o…

Single-use containment valves

Single-use containment valves

From GMP and HSE perspective material transfer is critical for chemical and pharmaceutical form…

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High containment split butterfly valve

High containment split butterfly valve

Powder containment is the cornerstone of chemical and pharmaceutical manufacturing. F…

Bellows for pharmaceutical powders

Bellows for pharmaceutical powders

Thermal and mechanical changes can lead to stresses in industrial piping systems. These s…

Ball valve

High containment segment ball valve

Valves fitted in blenders and dryers can have dead spaces that prevent complete processi…

high containment sampler

High containment sampler

Drawing a sample for evaluation from a running process is not a simple task, especially when dealing …

removable gmp compliant connections for tubing

Removable GMP compliant connections for tubing

Tubing frameworks can have rough welding joints, corners and sharp angles th…

Sterile Filtration System for GMP-grade products

Sterile Filtration System for GMP-grade products

Processing equipment used in industries regulated by GMP must ensure fully…

Semi-continuous freeze dryer with easy-loading

Semi-continuous freeze dryer with easy-loading

Freeze-drying is both a time- and energy-consuming process. In addition to t…

3D powder mixer for active pharmaceutical ingredients

3D powder mixer for active pharmaceutical ingredients

Proper mixing and homogenization are essential to achieve a reliable…

Continuous wet granulator and dryer for R&D

Continuous wet granulator and dryer for R&D

Pharmaceutical laboratories need compact equipment to handle and produce small …

Dry granulator for pharmaceutical powders

Dry granulator for pharmaceutical powders

In pharmaceutical industries, where large-volume production is the norm, compacto…

micronizing isolator

High containment micronizing isolator

Powder processing for chemical compounds demands product-specific micronizing solution…

Filter dryer discharging isolator

Filter dryer discharging isolator

Contained discharging is critical to the quality of filtration and drying processes. But p…

Accurate multiple dosing system for powders

Accurate multiple dosing system for powders

Dosing multiple powders in a batch process is time inefficient, especially when…

Powder micro-dosing system

Powder micro-dosing system

Pharmaceutical powders in metered doses demand maximum filling precision. This is particularly cha…

API containment isolator

API containment isolator

Contamination is a major concern in powder handling, not least when processing pharmaceutical product…

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Powder transfer system

Powder transfer system

Loading powder from a container source to vessels, tanks, or mixers that are under pressure may be haza…

Inspection system for tablets chemical composition

Inspection system for tablets chemical composition

The packaging of pharmaceuticals and oral solid products such as tablet…

Industrial high shear mixer granulator for drug formation

Industrial high shear mixer granulator for drug formation

It is rather difficult to successfully produce a pharmaceutical…

Fluid bed dryer for pharmaceutical solid dosage form

Fluid bed dryer for pharmaceutical solid dosage form

Fluid bed drying is a pharmaceutical process carried out to reduce th…

Hygienic floor scale

Hygienic floor scale

The food and pharmaceutical industries require maintaining high levels of sanitations as well as logistic…

Hygienic floor scale with lifting device

Hygienic floor scale with lifting device

The food and pharmaceutical industries require maintaining high levels of sanitatio…

Hygienic mobile scale

Hygienic mobile scale

Having a reliable and accurate weighing and measuring solution is absolutely essential, especially in th…

Fast gravimetric powder microdosing 50 - 200 g

Fast gravimetric powder microdosing 50 - 200 g

Micro-dosing powders of high-value food or chemical products can be challeng…

Gravimetric powder microdosing 2 - 100 g

Gravimetric powder microdosing 2 - 100 g

Powders and granules are commonly dosed for the manufacturing of pharmaceuticals, n…

Gravimetric powder microdosing 0.400 - 2 g

Gravimetric powder microdosing 0.400 - 2 g

If you need to process high value food, pharmaceuticals or chemicals, there is n…

High containment closing system

High containment closing system

Pharma and biopharma laboratories need fast effective solutions for tightly sealing bags for …

Single-use containment valve

Single-use containment valve

Safe transfer of liquids and hazardous powders into systems can be a challenge in pharma, biopha…

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Manufacturing API from a natural, synthetic, or semi-synthetic base


Synthetic APIs are developed from chemical conversions in a lab. Natural APIs, on the other hand, are derived from plants or animals and then purified. Semi-synthetic options stand somewhere in between. They are extracted from natural sources but then biochemically converted into the final Active Pharmaceutical Ingredient API.


The three main groupings of active pharmaceutical ingredients, however, employ similar extraction methods. The intermediaries are extracted from raw materials in a reactor before passing through a series of filtering and centrifuges for isolation and purification. Depending on the finished products, API are milled or freeze-dried before packaging. Distillation is also a key process used in the manufacturing of APIs. The distillation process is used to purify and isolate the desired compound from a complex mixture of chemicals.


 


Follow GMP standards for your API making equipment

Your API processing equipment must have official certification for reaching production standards.

There are multiple protocols, but Good Manufacturing Practices (GMP) are the global benchmark in pharmaceutical product certification. The World Health Organization (WHO) issues guidelines in this department but other jurisdictions such as China, the EU, and Canada have developed their own GMP.

Classification of API must be clearly displayed on your product label

There are hundreds of active pharmaceutical ingredients used for a wide range of finished pharmaceutical products. Orphenadrine, for example, is the main API found in muscle relaxants, while antivirals are composed of oseltamivir carboxylate. The pharmacological effects of antidepressants are driven by active ingredients such as memantine, amitriptyline, and citalopram. APIs come in various forms such as powders, liquids, tablets and capsules.

The WHO keeps and updates a catalog of all API, ensuring common application and labeling across all pharmaceutical manufacturing markets. The names of these ingredients are non-proprietary and must be displayed under the brand names of packaged pharmaceutical products.

HPAPI manufacturing requires expert containment solutions

The API sector is moving in the direction of highly potent active pharmaceutical ingredients (HPAPI). These special components deliver a stronger drug efficacy than regular API and at a reduced dose. Medicines made from HPAPI minimize side effects and are an important development in the treatment of chronic conditions.

Manufacturing HPAPI, however, raises a series of considerations. Producers must ensure strict handling and cleansing procedures to adhere to occupational exposure limits (OEL) and rigorous quality control to keep their workers safe.

Processing steps involved in active-pharmaceutical-ingredients-api making

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