b - Lactams
Pharmaceuticals Production in China
Released date: June 2006
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Being old items, b-Lactams
have been widely used in China for many years. Till today, they are the most favorable
medicines to Chinese people for their effective actions toward bacteria. Recent year, China saw the rapid but
disordered growth of beta-lactams production. The present report is to reveal some
fact about this industry in China.
1.
Brief Introduction to b-Lactams Production in China
From
Chemical Formula point of view, b-Lactams pharmaceuticals can be classified into
-
penicillins (including fermentation
penicillin and semi-synthetic penicillin)
-
cephalosporins
-
non-typical ¦Β-lactams
They are
similar in chemical structure and are effective in inhibiting the growth of
bacteria. Because of low toxicity
and wide spectrum toward bacteria they are widely used in clinical
therapy.
The
production of b-lactams in China started in
The
production of this kind of antibiotics has been increasing in the past few
years, as shown in the following
table.
Table 1.
Production of b-Lactams 1996-1998 (Unit: Mt)
|
Species/year |
1996 |
1997 |
1998 |
|
Penicillins |
4,847.449
|
5,954.391
|
6,217.000 |
|
Cephalosporins, |
152.555 |
209.004 |
413.120 |
|
Non-typical b-lactams |
4.774 |
3.125 |
27.080 |
Table
2. Production percentage of b-Lactams among the antibiotics
|
Year |
Fermentation penicillin |
Semisynthesis penicillin |
Cepharolosporin |
Non-typical¦Β-lactams |
|
1980 |
9.86% |
0.38% |
0.006% |
N/A |
|
1987 |
8.85% |
1.08% |
0.014% |
N/A |
|
1996 |
10.11% |
3.93% |
0.44% |
N/A |
|
1998 |
11.63 |
5.92% |
1.17% |
N/A |
Note:
N/A‘ͺnot available
At present
the production capacity of b-lactams is around 10,000Mt/year, over
80% are penicillins series. The rest are semisynthesis penicillins,
cephalosporins, and non-typical b-lactams.
It should
be pointed out that although b-lactams that are widely used in China,
some b-lactams that are powerful in clinical
therapy still rely on the imported products. E.g, about 15 kinds of antibiotics
are imported each year, 9 of them are b-lactams. This means that China is weak
in the production of these imported b-lactams.
2.
How is b-lactams Market
shared in China
The
present Chinese Market of b-lactams is shared by the following
participants:
-
The domestic manufacturers
They are
sharing most part of penicillins market.
These penicillins are favorable for their cheap price. Over tens of years of development, the
production of penicillins increased from nil to oversupply. But unfortunately the domestic
manufacturers still can not make an agreement to control the market in good
order. There is almost no rule for
these manufacturers. A large number
of manufacturers are competing each other by lowering the price of penicillins,
in order to share the ever-decreasing cake.
This
situation has arisen the attention from higher level of Chinese
government. The China
Pharmaceutical Industry Association called on the main penicillins
manufacturers in China, together with some officers from central government, in
mid 1999, to discuss how to control the penicillins market as a whole. The
proposal includes to fight the smuggling products and to stop issuing the
license for production of penicillin, amipicillin, etc. All these actions are to stop the
vicious competition among the Chinese manufacturers and to develop the high
value b-lactams instead of the low value
products.
Recent
years Chinese manufacturers began to develop cephalosporins and non-typical b-lactams,
which are mainly dominated by foreign companies. With the improvement on the technology
in producing penicillins, especially fermentation penicillin, nowadays it is
possible for China to develop the semi-synthesis penicillins. That means that the competition of b-lactams
has extended from fermentation penicillin in the past to semi-synthesis
penicillins nowadays, from cephalosporins raw to semi-synthesis cephalosporins,
until to a whole range of b-lactams.
-
The joint ventures in China
From the
very beginning these joint ventures aimed to occupy the b-lactams
product that required high production technology but are not available in the
domestic manufacturers, like second generation cephalosporins and non-typical b-lactams. The joint ventures in China, especially
those joint ventures that import raw material and convert into preparation and
sell it at high price to Chinese hospital, intensified the competition of b-lactams
market in China.
-
The imported b-lactams from oversea manufacturers
Every year
there is large quantity of penicillins entering China every year, legally or
illegally. This situation is very
obvious to some semi-synthesis cephalosporins. According to the statistics from customs,
total import value of 6-APA, 7-ADCA, 7-ACA amounted to USD133.7 millions in the
first half year 1996. This figure
did not include the smuggled ones. Although China has ability to produce 6-APA
and cefalexin, cefazolin, there are still a large number of imported products
appearing in China, because the competing ability of Chinese material is still
weak. On the other hand, a lot of Chinese importers would rather spending a lot
of foreign currency to import foreign products, just to meet the irrational
consumption ideology of some Chinese people, especially those living in the
large cities, who hold that foreign products are better than the Chinese
products. This phenomenon worsens
the already poor market for Chinese manufacturers.
3. Penicillins production in
China
1)
Overall situation of penicillins
production in China
New China
is the biggest penicillin manufacturer in the world. The total fermentation capacity of
penicillin is over 15,000Mt/year. By end 1998 there were about 12 kinds of
penicllins produced in China. These penicillins can be classified as follows:
-
penicillin series, including fermentation penicillin, penicillin
G. Potassium, Penicillin G. Sodium, Procaine penicillin G., penicillin V
potassium and long-acting procaine G.
-
Semisynthesis penicillins, including ampicillin, benzocillin,
amoxicillin, piperacillin, etc.
For nearly
half a century, penicillin has always been widely in clinical therapy and been
considered as an important and effective drug in China, whether in cities or in
the countryside. Being the
first antibiotics produced in China, fermentation penicillin has become one of
the biggest antibiotics item nowadays. It is reported that in 1997, about
3,000-4,000 Mt of the fermentation penicillin was turned into penicillin G.
sodium/potassium , 2,600Mt of which were exported to the oversea market. The production of penicillin
G. in 1998 was 6,538Mt and 8,500Mt, repectively. In 1999, about 3,000Mt of
penicillin G was exported.
So far the
biggest penicillin manufacturers in China include
-
Northern China Pharmaceutical Group
-
Shandong Lukang Pharmaceutical Company
-
Harbin Pharmaceutical Factory
-
Shijiazhuang Pharmaceutical Group Company
These
three manufacturers almost produced about 3200 Mt of penicillins in 1998,
occupying over 50-70% of the total production in China. It is estimated that the present
capacity in these four manufacturers accounts to 75.4% of the total production
capacity in China.
As a
matter of fact, the penicillins are oversupplying nowadays, especially
fermentation penicillins. It is
expected that the present capacity of some fermentation penicillins can meet
the demand in the future ten years.
These penicillins include penicillin G. sodium, ampicillin, and
amoxicillin.
Recent
years the China has developed fast in the production semi-synthesis
penicillins. The production of
semi-synthesis penicillins has increased from about 200 Mt in 1994 to 1000 Mt
in 1996, till about 1600 Mt in 1998.
The big items of semi-synthetic penicillins include ampicillin and
amoxicillin. The production of amoxicillin in 1999 was 1,158Mt.
Among the
production of semi-synthetic penicillins, 6-APA is an important intermediate.
At present the production capacity of 6-APA is 3,000Mt/year. The active manufactures of 6-APA include
-
Shandong Xinhua Pharmaceutical Group Co. Ltd.
-
Harbin Pharmaceutical Factory
-
Shandong Lukang Pharmaceutical Factory
-
Hebei Pharmaceutical Company
-
Sichuan Pharmaceutical Factory
-
Dongfeng Pharmaceutical Factory
The
improvement in China shows it begin to get ride of the reliance on foreign
semi-synthesis penicillin. As it
needs much more money to do the R&D work and only those large
pharmaceutical manufacturers have ability to do research, there is a long way
to go for Chinese manufacturers to go in the future.
The
character of Chinese penicillins production is
-
The product species are not as various as in developed countries.
Still, and as for many year, the Chinese penicillins cover penicillin G. sodium
or penicillin G. potassium, ampicillin and procaine penicillin G.
-
The production of
semisynthesis is rather small. The
development for semi-synthesis products step behind foreign countries. The main reason is that the domestic
manufacturers lack the enough money to do R & D . In the past, attracted by the large
demand for penicillin in China, many manufacturers introduced the same set of
production line in the same period. It was hard for them to digest the
technique sufficiently. The result
is that many factories have the same facilities but many facilities are idled.
-
There are no acquiescent rules among Chinese manufacturers. They compete each other severely by
lowing the selling price. This situation is obvious during the export. This gives the chance for foreign buyers
to bid more. Some domestic
manufacturers sold penicillins at deficit in order to gain the order. The vicious competition led to the sharp
drop of the price of penicillin in 1997.
Some small manufacturers were forced to stop and driven out of the
market.
-
Now nearly all of the penicillins in China are consumed in
China. The export quantity is
relatively small. If there were
export, it is pertinent to fermentation penicillin/salts.
Table
3. The production of penicillins
during 1996-1998 (unit: Mt)
|
Product
name/year |
1996 |
1997 |
1998 |
Capacity
in 1998 |
|
Penicillin
G. Sodium |
2,940.733 |
3,442.874 |
3,357.690 |
4,310.100 |
|
Penicillin
G. potassium |
548.966 |
530.014 |
679.020 |
6,453.000 |
|
Penicillin
V. potassium |
0.000 |
47.066 |
82.560 |
N/A |
|
Procaine
penicillin G. |
246.510 |
376.243 |
206.550 |
2,087.040 |
|
Longacting
penicillin G. |
25.038 |
22.033 |
23.060 |
N/A |
|
Ampicillin |
962.432 |
1,062.403 |
1,091.1601 |
2,066.000 |
|
Oxacillin |
54.286 |
35.848 |
62.980 |
85.000 |
|
Carbenicillin |
1.348 |
24.000 |
0.300 |
N/A |
|
Ekavacillin |
0.821 |
1.630 |