Tag: Caplin Point Laboratories

Caplin Point Labs gains on approval from Colombia’s INVIMA for Puducherry facility

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Caplin Point Laboratories shares gained in morning trade on Monday after the company announced receiving approval from Colombia’s National Institute of Drug and Food Surveillance (INVIMA) for its Softgel Capsules division located in Puducherry.

The company informed the bourses in a filing that the site inspection was completed by the Colombian drug regulator on May 3 and the site was found to be compliant with INVIMA’s norms.

“The site inspection of Unit-1 was completed on May 3 and found compliant as per INVlMA’s norms of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP),” the company said.

Commenting on the development, CC Paarthipan, Chairman, Caplin Point Laboratories, said that the expansion into larger markets of Latin America is an important aspect of the company’s growth plan.

“Expansion into larger markets of Latin America such as Colombia, is an important aspect of our future growth, and this approval, especially in the niche Softgel Capsules range will contribute well to the same,” Paarthipan said in an official release.

After the announcement, shares of the company gained as much as 1.71% to hit an intraday high of ₹1,321 apiece on the BSE. However, shares of Caplin Point Labs pared some of the early gains to trade at ₹1,294.55, down 0.33%, on the BSE at 12:36 PM.

The company also mentioned in the release that it caters to the Latin American and African markets with a variety of dosage forms, such as tablets, capsules, suppositories, and other pharmaceutical offerings.

“The Unit currently caters to Emerging Markets of Latin America and Africa with a variety of dosage forms such as Tablets, Capsules, Softgel Capsules, Suppositories, Liquid Orals, Topicals and Injectables,” the company said.

Caplin Point Laboratories is a leading player in the pharmaceutical industry, with a significant presence in Latin America, Africa, the United States and the European Union. The company has 4,000 product licences.

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Caplin Point Labs gains as arm gets USFDA nod for eye infection treatment drug

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Caplin Point Laboratories Ltd shares gained over 2% on Tuesday after the company said that its subsidiary Caplin Steriles Ltd has received final approval from the United States Food and Drug Administration (USFDA) for an eye infection treatment drug.

The company, in a stock exchange filing, said that its subsidiary has received approval from the US drug regulator for Ofloxacin Ophthalmic Solution, used in treating eye infection.

The company has received the Abbreviated New Drug Application (ANDA) Ofloxacin Ophthalmic Solution USP 0.3%, a commonly used eye drop.

This clearance positions Caplin as a player in the generic therapeutic equivalent market, offering an alternative to the branded version, OCUFLOX Ophthalmic Solution of Allergan Inc, Caplin Point Labs said in a stock exchange filing.

Ofloxacin Ophthalmic Solution USP 0.3% is indicated for the treatment of eye infections, especially conjunctivitis and corneal ulcers.

With this approval, Chennai-based Caplin aims to provide patients with effective treatment options.

According to IQVIATM (IMS Health), Ofloxacin Ophthalmic Solution USP 0.3% recorded significant sales in the US, with approximately $52 million in revenue for the 12-month period ending December 2023.

This shows the market demand and potential for Caplin’s generic version.

Caplin Steriles has developed and submitted 41 ANDAs in the United States, both autonomously and in collaboration with partners, resulting in 27 successful approvals to date. Additionally, the company is actively engaged in developing a diverse portfolio of over 40 simple and complex Injectable and Ophthalmic products, slated for submission over the course of the next four years.

Furthermore, Caplin Steriles has numerous products currently under review and approved in various international markets outside the US, including Mexico, Australia, Canada, South Africa, among others.

In February, Caplin Point Laboratories announced that it expects the introduction of four new products in the ophthalmic injectables sector in the US, which are poised to significantly contribute to the company’s growth in the American market.

Shares of Caplin Point Laboratories were trading 1.35% higher at ₹1,318 apiece on the NSE at 2.48 PM.

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Pharma firm Caplin Point expects opthalmic injectables launches to drive US growth in coming year

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Chennai-based pharma company Caplin Point Laboratories expects four new launches in the ophthalmic (eye-related) injectables space in the US and these could be among the key drivers for the company’s growth in the US market.

Currently, the US (North America) contributes roughly 17% to the overall business, and sales there are currently primarily driven by the company’s subsidiary, Caplin Steriles, that manufactures injectables and ophthalmic products for regulated markets.

Vivek Partheeban, COO of the company said, “In the next four or five months, we are expecting about four product approvals and interestingly, all these are going to be in the ophthalmic space in the US.”

He expects the US business to grow at over 40% over the next 18 months given the low base and the new launches.

The Latin American market contributes the balance 83% to the company’s business, and is expected to grow at around 11-13%. At a consolidated level, the growth will be in low teens, he said.

Over the next 18-24 months, he also expects other smaller markets such as Mexico and Chile to begin contributing higher to sales.

In the third quarter of the current financial year (FY24), the company reported revenue from operation of ₹435.50 crore, up 17.0% year-on-year (YoY). Earnings before interest, taxes, depreciation, and amortisation (EBITDA) was at ₹142.30 crore, up 30% YoY, while profit was up 20% YoY at ₹117.20 crore.

Partheeban noted that there are certain product segments where the company does not have a presence yet, while pointing out Caplin currently has over ₹800 crore of cash on books. “Without giving too much away, because we’re at very early stages of evaluation, we’re not against anything inorganic, that’s, what I would like to leave it at,” he said.

On January 8, Caplin Point signed a Memorandum of Understanding (MoU) with the state government during the Tamil Nadu Global Investors Meet, 2024.

Under the MoU, the Caplin group of companies, which includes Caplin Point Laboratories along with its subsidiaries Caplin Steriles and Caplin One Labs pledged an investment of ₹700 crore over the next 5 years.

The company, which has a market capitalisation of ₹10,850 crore, has seen its shares gain 113% over the last year.

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Caplin Point Laboratories commits ₹700 crore investment in Tamil Nadu

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Drug firm Caplin Point Laboratories Ltd on Monday (January 8) said it has signed a Memorandum of Understanding (MoU) with the state government during the Tamil Nadu Global Investors Meet, 2024.

Under the MoU, the Caplin group of companies, which includes Caplin Point Laboratories along with its subsidiaries Caplin Steriles Ltd and Caplin One Labs Ltd, has pledged an investment of ₹700 crore over the next 5 years.

“This MoU outlines Caplin Group’s commitment to invest ₹700 crores over a period of 5 years in diverse projects. This investment will be made by Caplin Point Laboratories Limited and its subsidiaries – Caplin Steriles Limited and Caplin One Labs Limited,” according to a stock exchange filing.

This investment is earmarked for diverse projects spanning Oncology, Active Pharmaceutical Ingredients, and Research and Development facilities, the company said.

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In return for this substantial investment, the Tamil Nadu government has committed to providing necessary infrastructure support and regulatory assistance, adhering to applicable laws. Caplin Group’s projects are expected to generate a total of 1,500 employment opportunities, with 1,000 direct jobs and 500 indirect jobs.

“The investments, spanning Oncology, Active Pharmaceutical Ingredients and R&D facilities, are projected to generate 1,500 employment opportunities (1,000 direct and 500 indirect),” the company added.

C C Paarthipan, Chairman said, “We are pleased to announce the signing of an MoU with the Government of Tamil Nadu. Aligned with the state’s goals, our company’s strategic investment emphasizes expanding manufacturing capabilities and driving research and development.”

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Shares of Caplin Point Laboratories Ltd ended at ₹1,392.15, down by ₹8.25, or 0.59% on the BSE.

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Caplin Point Labs’ subsidiary gets final USFDA nod for skeletal muscle relaxation Injection

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Tamil Nadu-based pharma company Caplin Point Laboratories Ltd. on Friday announced that the United States Food and Drug Administation (USFDA) has granted final approval to the company’s subsidiary Caplin Steriles Ltd. for Rocuronium Bromide Injection, a neuromuscular blocking agent.

The company said that the US drug regulator has approved its Abbreviated New Drug Application (ANDA) for Rocuronium Bromide Injection, 10 mg/mL in 5 mL and 10 mL multi-dose vials, a generic therapeutic equivalent version of Organon USA Inc’s Zemuron injection.

Rocuronium Bromide Injection is a neuromuscular blocking agent, used as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

The Rocuronium Bromide Injection had US sales of approximately $53 million for the 12-month period ending September 2022, according to healthcare information services company IQVIA.

Caplin Steriles Ltd. is a niche sterile product manufacturing company that has developed and filed 29 ANDAs in the US on its own and with partners. The pharma major has received 19 approvals so far. The company’s subsidiary caters to the rapidly growing demand for injectable products in the US and other regulated markets.

Recently, ICICI Direct maintained its ‘buy’ call on the stock, with a 12-month price target of Rs 865 per share.

In a research note dated February 14, brokerage firm ICICI Direct said, “Banking on a strong footprint in the smaller LatAm (Latin American) markets, the company is establishing itself in the complex US injectable space besides foraying into bigger LatAm markets. We are positive on the company’s strong earnings profile and focused approach with growth capex.”

Shares of Caplin Point ended 0.5 percent higher at Rs 659.05.

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Caplin Point Lab expects Mexico, Brazil to be key markets for Latin America biz

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Caplin Point Laboratories stock is down 10 percent today and was down almost 21 percent in August, and over 30 percent from its 52-week high in July. To understand exactly what is ailing the company, CNBC-TV18 caught up with Vivek Partheeban, COO, Caplin Point Lab.

Partheeban said, “It has been business as usual and there have been no changes at all with the overall performance of the company and what happens in the capital market is not in our control. Having said that, when it comes to the virtual US FDA audit, it is a big positive for us. At a time when FDA audits are not happening, we have received confirmation that our Amaris clinical is going to have an audit from September 21 or 25, and we are just submitting all the documents to the FDA for that. We have been waiting for this for a long time.”

The company’s injectable plant was last audited a couple of years ago. So when asked if there was any fresh update on that, he said, “Our last audit was in June 2019. It was a successful audit, and we got the EIA within a month itself. And there has been no other audit that has been announced. However, in our business, we have to be ready on a daily basis. It is supposed to be anytime ready. So, if anything is announced on that front, we will obviously be ready to face it.”

“We maintain a very high level of compliance. We’ve had multiple successful audits at the plant and on the compliance front, we have never diluted,” he further said.

The company reported its Q1FY22 earnings, its revenues were up 25.1 percent at Rs 300.4 crore versus Rs 240.08 crore for the same period last year and EBITDA too was up 29.3 percent year-on-year (YoY) to Rs 92.6 crore versus Rs 71.6 crore. The YoY margins were up 30.8 percent versus 29.8 percent.

Talking about the Brazilian authority inspecting and approving their Chennai plant, both Brazil and Mexico being new markets for the company, he said, “This is a desktop audit that had happened because of our successful USFDA and EU GMP audit. For Brazil, because travel is not possible for the auditors, they have taken cognizance of high compliance record with regard to other countries and approved us on a desktop basis,” he clarified, adding that Brazil is a key market for them and going forward, Mexico and Brazil will both be very important.

“We have started product registrations in Brazil and Mexico, and we have also started some emergency tender business. For an overall organic business, we expect something out of these markets in the next 18-24 months,” he said.

He further said, “Mexico is much more of a focus market in the short to midterm for us because of contiguous expansion in Latin America, as we are in multiple markets in Central America itself. So, we are focussing on Mexico very closely. As far as Brazil is concerned, we need a good partner there and we have finally found a couple of people that we were working with, and we feel quite confident.”

“Things are very fluid, dynamic at the moment. So, we don’t want to get into numbers. But obviously, these two are, especially for a company that has a large exposure to Latin America, we feel Mexico and Brazil are going to be key markets for us in the future,” said Partheeban.

For the entire interview, watch the video

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow