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[🇧🇩] Pharmaceutical and Chemical Industry in Bangladesh

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[🇧🇩] Pharmaceutical and Chemical Industry in Bangladesh
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Renata wins EU nod for drug exports

FE REPORT
Published :
Jul 17, 2025 09:53
Updated :
Jul 17, 2025 09:53

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Renata's export horizon will expand further as it has secured approval of the European Union months after an audit by European auditors of one of its production units.

In a stock exchange filing on Wednesday, the listed drug maker disclosed that its Rajendrapur production unit had received European Union Good Manufacturing Practice (EU GMP) certification following a comprehensive audit by European authorities.

With that, Renata joins a small group of Bangladeshi pharma companies - Beximco Pharma, Incepta and Square Pharmaceutials -- that have EU GMP facilities.

Company officials said the certification had opened a door to the EU countries for exports of Renata's products.

Renata had already been exporting its products to the EU markets but on a limited scale in the absence of the certification. "Now, there is scope of getting approvals for a good number of our products by EU drug administrators," said Md. Jubayer Alam, company secretary of Renata.

The EU GMP certification confirms that the facility is compliant with strict European standards in manufacturing medicines, covering everything from hygiene, production, quality control, and documentation.

It is a mandatory requirement to export drugs to EU countries, which means Renata can now start expanding exports to Europe, adding a new revenue stream and increasing foreign exchange earnings for Bangladesh.

Conforming to the EU GMP usually involves significant investments in facilities, processes, and training. It pushes a company to improve its overall operational standards.

The same unit in Rajendrapur had secured access to the UK market and received approval of the US FDA, the world health organisation and the Brazilian Health Regulatory Agency.

The EU auditors conducted the audit in February and the company received the certificate of GMP Compliance on Tuesday.

The annual export volume of Renata is around $25 million at present.

"The company's export volume will increase following our easy entry into the EU market," Mr Alam said.

The certification by the EU authorities is also accepted by the countries of Latin America.

"So, it will facilitate our exports to the markets of Latin America," Mr Alam added.

EU GMP is one of the most respected quality standards globally. It enhances Renata's credibility with global partners, investors, and regulatory authorities.

Therefore, the access to the EU may lead to new partnerships, higher stock valuations, and greater trust of institutional investors.

Meanwhile, investors appeared enthusiastic about bidding up shares of Renata as the stock price moved up 0.39 per cent to Tk 490.20 per share by the end of the trading session on the Dhaka Stock Exchange on Wednesday.​
 

Heavy import reliance leaves pharma industry vulnerable
Drugmakers call for setting API production as a strategic priority


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Local medicine manufacturers can meet almost the entire domestic demand and export to as many as 160 countries, given that supplies of raw materials come from China and India.

But without these imported ingredients, the 45-year-old pharmaceutical industry cannot produce even something as basic as Esomeprazole—a commonly used tablet to treat heartburn.

Industry insiders say it is high time Bangladesh invested in the development of active pharmaceutical ingredients (APIs) to reduce its annual import bill of roughly $1.3 billion, improve resilience, and ensure long-term growth.

Meanwhile, health economists say delays in building API capacity could lead to patent-related issues. Bangladesh currently enjoys a patent waiver as a least developed country, but that exemption will end when the country graduates from the LDC club in November next year.

According to local drugmakers, around 85 percent of drug ingredients are still imported, mainly from China and India. Efforts to manufacture these locally are obstructed by gaps in the production ecosystem, regulatory hurdles, a shortage of skilled workforce, and limited access to finance.

To resolve these issues, they have called for an API policy to support local initiatives.

At least six domestic firms, including Square, Beximco, ACME and Incepta, currently produce 40 types of APIs worth Tk 2,500 crore.

Rabbur Reza, chief operating officer of Beximco Pharmaceuticals, said, "Bangladesh must stop treating API production as the responsibility of individual companies and instead prioritise it as a national strategic objective."

"Even when we try to manufacture APIs locally, there are approval delays of eight to nine months just to import the ingredients, as the process requires 18 separate clearances," said Reza.

"By the time we receive the go-ahead, global prices have shifted or competitors have beaten us to market," he said.

He said API byproducts from one industry feed another in China. "That is how they have built a cost-effective, integrated model. We need to replicate that thinking here."

To support the local pharmaceutical industry, the government has set up an API industrial park in the Gajaria area of Munshiganj. While land has been acquired and infrastructure developed, the site does not have a gas connection, making it an unattractive location for API ventures.

The Beximco pharma executive said that without coordination between agencies and a single-window clearance system, the API park could become another underused industrial zone.

"We are ready to invest, but policy must support viability," he commented.

Abdul Muktadir, president of the Bangladesh Association of Pharmaceutical Industries (Bapi), said, "We have made great strides in pharmaceutical formulations, but without local API capacity, our base remains fragile."

Referring to the API park, Muktadir said no chemical plant can run on LPG.

Besides, he said that access to affordable finance is another major challenge for API manufacturing.

According to the Bapi president, with bank interest rates hovering around 14 percent to 15 percent compared to 3 to 5 percent in India and China, API ventures in Bangladesh face unsustainable capital costs.

Muktadir also pointed to a shortage of local expertise in process chemistry and chemical engineering, both prerequisites for API manufacturing.

He said some progress has been made through training and hiring foreign consultants, but scaling up will require long-term policy backing.

The post-pandemic shift in global supply chains has opened a window of opportunity, as Western countries seek alternatives to Chinese API suppliers.

"This is our window," Muktadir said. "If we move fast, Bangladesh can become a credible second source."

The Bapi president urged the government to promote import substitution and export of APIs, and to strengthen public-private collaboration in research and development.

"We don't need subsidies," Muktadir said. "We need basic support such as energy and finance. The government should also recognise that API is a national infrastructure."

Syed Abdul Hamid, professor at the Institute of Health Economics at Dhaka University, said that once Bangladesh loses its LDC patent waiver, the cost and complexity of producing patented APIs will rise manyfold.

"Local firms currently depend on flexibility to produce or import APIs without patent barriers. After the graduation, licensing will be mandatory, making it harder and costlier to produce newer, high-priority drugs, especially for drug-resistant or emerging diseases."

Prof Hamid commented that Bangladesh's limited API production capacity leaves it vulnerable to supply shocks and price fluctuations in the global market.

"Without investment in domestic production and technology transfer, access to essential medicines could become unsustainable," he said.

Monjurul Alam Monju, chief executive officer of Beacon Medicare, said Bangladesh cannot feasibly produce all types of APIs domestically, especially those with limited demand.

He said, "API manufacturing is a long-term investment, especially for innovative molecules like cancer drugs. India and China can afford this due to their massive internal markets. Without access to global markets, such investments are not viable here."

However, Monju said some API products serving the local pharmaceutical industry could be produced profitably with the right policy support.

He also raised concerns about the high cost of setting up effluent treatment plants (ETPs), a mandatory requirement for API manufacturing.

"ETPs require a huge investment. Without government support, it is extremely difficult for local firms to comply," he said.

"If the government provides subsidies for R&D and environmental compliance, API manufacturing can become feasible," he added.​
 

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