How to source and secure your progesterone hormone supply?

Progesterone is a super hormone. It’s a steroid hormone that is secreted by the female reproductive system; linked to the menstrual cycle, pregnancy and embryo development. It is therefore vital for our human race to continue to thrive.

Progesterone isn’t just about growing healthy babies. In its artificial form, progestin, is used in many applications:

• Contraceptive pill – Progesterone is used to prevent pregnancy without the adverse effects of oestrogen (in the combined pill). It is also used in Assisted Reproductive Technology (ART) treatment for women.
• Hormone replacement therapy (HRT) – HRT is an option to relieve the symptoms of the menopause and prevent osteoporosis (bone weakening). Taking progesterone alongside oestrogen minimises the risk of developing endometrial cancer.
• Weight loss – Progesterone and oestrogen levels have been linked to weight fluctuation in women. When oestrogen levels increase, the side effects can be an increase in water retention (bloating) and an increased appetite. By balancing this higher oestrogen level with progesterone, women can reduce their sugar cravings, bloating and ultimately lose weight.
• Sleep aid – Progesterone is a natural sleep aid. Unlike oestrogen, which has a stimulating effect on the brain, progesterone calms the brain instead. 
• Veterinary industry – Progesterone is used for stimulation and synchronisation of heat in animals during breeding/reproduction.

 Also used in the Assisted Reproductive Technology (ART) treatment for women

We can add also the use in the veterinary industry : triggering and synchronization of heat in the animal (the use in vet market is limited compared to human but we do have some vet clients)

Progesterone is therefore extensively used worldwide. This high demand is increasing yearly, as stated on Market Data Forecasts, “the global progesterone market size was forecasted to grow with a CAGR of 14.4% between 2020 to 2025”

Since COVID-19, the pharmaceutical supply chain has again been negatively impacted by trade route changes, border closures and lack of transportation. Transport from China was unreliable, however, despite pharmaceutical supply chain challenges, it seems to be improving as of this article being written.

There have also been limits to medicine exports by some countries.  Shortages of shipping containers in China have also made the whole pharma supply chain situation more dire.  

With fears of global shortages, it is certainly vital that your supplies are from a company, like Safic-Alcan, who has solutions to these shortages.

At Safic-Alcan, we offer progesterone via two pharmaceutical manufacturing processes. The two processes are dependent on two different raw materials that are used.

• Process 1

The raw material that is used is 16DPA. It comes from a plant that needs to be harvested. This is obviously seasonal and yields are dependent on uncontrollable factors, i.e. weather. As there is a fluctuation in the supply of the raw material, there is also a fluctuation in price which can make it hard for long-term supply and demand planning. The volumes also tend to be smaller.

We, at Safic-Alcan, have 30 years of experience with this process and gained our CEP in 2003.

The production capacity is 100Mt/year with a batch size of 500kg.

Due to the unreliable and unpredictable supply of 16DPA, a new process was invested in.

• Process 2

The new process uses BA as its raw material. BA comes from soy and is therefore available all year round without seasonal disruptions.

As a result of a more stable supply of the raw material, there are advantages:

• More economical as the yield is higher and faster to manufacture
• More competitive and stable price; less fluctuation
• Possibility to implement multi-annual contracts
• Better impurity profile (lower impurity content)
• Customised in-process micronisation (to meet particle size specifications)

The production capacity is 150Mt/year with a batch size of 500kg. The CEP is due to be obtained in the first half of 2022.

At Safic-Alcan, we are proud partners with Zhejiang Shenzhou Pharmaceutical. In fact, we have been since the 1990s!

An overview of Zhejiang Shenzhou Pharmaceutical:

• Two manufacturing sites in Eastern China
• Private company with 450 employees
• Turnover was 49 million dollars in 2019 (65% from exports)
• Specialised in the production of steroid API’s including progesterone for over 30 years

The new BA process will be housed in a new factory. Construction started in 2015 on the Yangfu site and was commissioned in 2018. Commercial production started in 2019 using process 1.

This brand-new factory meets environmental regulations. It was built in Xianju county (outside of Shanghai) to meet the Chinese governments’ pollution reduction requirements. It therefore will not have to be moved in the future; meaning no disruption in the pharmaceutical supply chain.

The Yangfu site, which follows the GMP guidelines, has two dedicated workshops for progesterone (one for each process). It also has its own waste and gaseous treatment facilities. They, therefore, treat the waste themselves so can be sure they are in control and passing regulations.

At Safic-Alcan, we have been supplying the API progesterone in Europe since the early 2000s from our manufacturers, Zhejiang Shenzhou Pharmaceutical.

From a regulatory standpoint, we have been successful.  From the development of the first CEP of progesterone produced in China in 2001, by us at Safic-Alcan, the product is now registered in MA dossiers in more than 70 countries; highlighting our strong active pharmaceutical ingredient supply chain and validating that GMP is being followed by Shenzhou.

The first successful EDQM inspection in 2007 was on our request after helping Shenzhou achieve compliance. At Safic-Alcan we are invested in the manufacturing of progesterone. By initiating the comments for Pharmeuropa (n° 23, 3, 2011) for the new EP8.3 monograph of progesterone we ensured that the texts stayed relevant and fit for purpose.

Now, for the new CEP in preparation, Safic-Alcan provided QARA support to Shenzhou in their EDQM response to ensure we obtain it. This illustrates one of the company’s strengths: our support on all QARA matters, for both our clients and our producers.

On a business level, our partnership with Shenzhou has other major strengths:

• Adaptable to customers’ specification (e.g. particle size)
• Implementation of tripartite quality agreements (between Safic-Alcan (us), Shenzhou (as our partner), and you (the client))
• Globalisation of volumes to provide competitive prices
• Turnkey delivery: directly to the client’s factory
• Possibility to implement safety stocks in France (our solution to future potential shortages)

From a cultural perspective, Safic-Alcan has a team working in the field in China. This allows daily contact, regular on-site visits and management of cultural differences to keep everything running smoothly at the Shenzhou manufacturing sites. Our team in China cover a range of different sectors to help with any language barriers or supporting the technical Chinese team as they are aware of Chinese regulations being immersed in them daily.

The huge benefit of this arrangement is that any issues that arise are dealt with quicker and more efficiently.

As mentioned before, the team also support quality assurance and regulatory affairs, as examples:

• Support on CEP/DMF submission
• Support in customer’s validation and R&D projects
• Support during audits and CAPA follow-up
• EHS monitoring
• Analytical laboratory support

As we, at Safic-Alcan, have a long and successful relationship with our pharmaceutical supply chain, it makes us the best distribution company to source and secure your progesterone supply. The new manufacturing process will start to overtake the old process in the coming years since it offers supply chain resilience in the pharmaceutical sector. Enquiries are currently being taken as the CEP is due to be obtained in 2022.

For more information on our reliable and cost-effective supply of progesterone, contact us below.