GlaxoSmithKline (GSK) began construction of an oral solid-dose manufacturing plant at the Vemgal Industrial Area in India in September 2015.
Farmak is a traditional Czech-based company specialized in the field of API and fine chemicals manufacturing. Chemical production has been running at its manufacturing site since 1934, and for the past few decades APIs have been the company’s main focus.
API development, pilots and commercial production
Farmak provides a complete range of services for APIs, including laboratory development, kilo lab, pilot plant and commercial-scale production. Such services are also offered for custom synthesis and toll manufacturing. All its products are provided with relevant regulatory documentation.
Benefits of using Farmak include:
- Farmak is specialized in the chemistry of heterocyclic compounds
- All state-of-the-art production units are multipurpose
- Total reactor capacity is around 215m³
- APIs are manufactured in cGMP and FDA approved units
- Various commercial scale production units also include a cGMP kilo lab and cGMP pilot plant which are also used as scale-up equipment
Generic and niche APIs
Farmak’s development and commercial pipeline includes mainly generic and niche APIs made by multistage syntheses. Leading commercial products are alfuzosine hydrochloride, brimonidine tartrate, butamirate citrate, tizanidine hydrochloride, moxonidine and zolpidem tartrate.
API documentation, quality assurance, quality control and regulatory support
For all APIs manufactured, Farmak provides clients with full, continuously updated documentation (USDMF, EDMF and CEP/CoS). Currently around 40 DMFs are actively maintained. For three products – alfuzosine hydrochloride, zolpidem tartrate and zopiclon – Farmak is a holder of CEP.
The level of Farmak’s cGMP standards is inspected by local authority SUKL (a member of PIC) every three years. Additionally, Farmak has successfully passed several US FDA inspections since 1996. The company’s analytical centre with a staff of 26 specialists provides in-process control as well as final batch release according to either in-house or pharmacopoeial methods.
Synthetic, analytical and chemical engineering R&D
Farmak’s management lays considerable emphasis on innovation activities. Therefore, Farmak has a highly qualified R&D team formed of 40 employees. The company’s R&D centre is divided into several departments – synthetic, analytical and chemical engineering, intellectual property, and a production technology department. The R&D centre laboratories are equipped with a whole variety of high-tech equipment.
Pharmaceutical contract and toll manufacturing
Besides its own product development and manufacturing, Farmak’s facility provides cost-efficient toll manufacturing services to partners from the originator as well as the generic side of the pharmaceutical market. This was proven by several projects that were implemented with the support of Farmak’s internal R&D, scale-up and QA/QC team. Farmak can offer a contract manufacturing scale ranging from 100g to 300kg per batch.
Multipurpose production facility
Farmak’s multipurpose production facility operates under GMP standard and majority of the manufacturing units have been FDA approved. Farmak’s products are used by a large number of customers in 40 countries worldwide – mainly in regulated markets (EU, US, Canada, Japan and South Korea).
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In August 2017, Sri Lanka-based pharmaceutical company Navesta Pharmaceuticals opened a sterile manufacturing facility in the town of Horana.
Chugai Pharmaceutical announced its decision to construct a new plant for manufacturing antibody active pharmaceutical ingredients (APIs) at the existing Ukima Plant located in Kita-ku, Tokyo, Japan, in October 2015.