The EIR was issued post the last inspection of the facility conducted from March 21 to March 29, 2023. The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI).

VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.

“We are pleased to have received the EIR from the US FDA with a satisfactory VAI status for our Pithampur Unit-2 facility. This is a significant milestone as we build back our reputation of being best-in-class in Quality and Compliance. We look forward to new products approvals and launches, especially ophthalmic products from this facility now,” said Nilesh Gupta, Managing Director, Lupin.

Read also: USFDA inspection: Lupin gets 10 observations for Pithampur facility

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

Read also: Lupin CSR arm, Maharashtra Govt collaborate to address growing prevalence of cardiovascular diseases, COPD

The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 7.9% of its revenue in research and development in FY23.

Lupin has 15 manufacturing sites, 7 research centers, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.

Read also: Lupin gets USD 25 million from AbbVie for novel MALT1 inhibitor program to treat hematological cancers

Mumbai: Global pharma major Lupin Limited today announced that
it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for
its Abbreviated New Drug Application (ANDA), Dolutegravir Tablets for Oral Suspension, 5 mg.

The product is a generic equivalent of Tivicay PD Tablets for Oral Suspension, 5 mg of ViiV Healthcare
Company.

Dolutegravir is an antiretroviral medication used, together with other medications, for the treatment of HIV/AIDS.

This product will be manufactured at Lupin’s Nagpur facility in India.
Dolutegravir Tablets for Oral Suspension (RLD Tivicay PD ) had estimated annual sales of USD
1 million in the U.S. (IQVIA MAT March 2023).

Read also: Lupin bags USFDA nod for generic equivalent of Nascobal Nasal Spray

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The
Company develops and commercializes a wide range of branded and generic formulations, biotechnology
products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin
America (LATAM), Europe, and Middle East regions.
The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has
a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s
health areas. The company
invested 7.9% of its revenue in research and development in FY23.
Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has
been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.Read also: Lupin receives over Rs 205 crore from AbbVie for meeting key product development milestone

The product is a generic equivalent of Nascobal Nasal Spray, 500 mcg/spray of Par Pharmaceutical, Inc. This product will be manufactured at Lupin’s Somerset facility in the US.

Cyanocobalamin Nasal Spray (RLD Nascobal) had estimated annual sales of USD 69 million in the U.S. (IQVIA MAT Mar 2023).

Cyanocobalamin is a form of vitamin B12 used for the treatment of deficiency of vitamin B12.

Read also: Lupin CSR arm, Maharashtra Govt collaborate to address growing prevalence of cardiovascular diseases, COPD

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 7.9% of its revenue in research and development in FY23.

Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.

Read also: Lupin gets USD 25 million from AbbVie for novel MALT1 inhibitor program to treat hematological cancers

The company has achieved a key milestone for its novel MALT1 (Mucosa-Associated Lymphoid Tissue Lymphoma Translocation Protein 1) inhibitor program that is partnered with AbbVie Inc towards treatment across a range of hematological cancers, the Mumbai-based drug maker said in a statement.

As part of the agreement, Lupin has received USD 25 million from AbbVie for initiation of Phase 1 clinical studies successfully, it added.

The drug maker had earlier received USD 30 million from AbbVie for achievement of other milestones in the programme.

Read Also: Lupin Unveils Rufinamide Oral Suspension For Seizure Disorder In US

"This achievement is further validation of our ability to successfully develop novel treatments for unmet needs. We look forward to continued successful development of this important treatment for patients with difficult-to-treat cancers," Lupin Managing Director Nilesh Gupta said in a statement.

Lupin and AbbVie inked the licensing, development, and commercialisation agreement in 2018 for a novel oncology drug to treat hematological cancers.

The company said its novel drug discovery and development (NDDD) team is focused on building a pipeline of highly differentiated and innovative new chemical entities in the oncology space.

Read Also: Lupin Receives Over Rs 205 Crore From AbbVie For Meeting Key Product Development Milestone

Mumbai: Global pharma major Lupin Limited has announced the
achievement of a key milestone for its novel MALT1 (Mucosa-Associated Lymphoid Tissue
Lymphoma Translocation Protein 1) inhibitor program that is partnered with AbbVie Inc. towards treatment across a range of hematological cancers.

As part of the agreement, Lupin has received USD 25 million from AbbVie for initiation of Phase 1
clinical studies successfully. Lupin had earlier received USD 30 million from AbbVie for achievement
of other milestones in the program.

Lupin and AbbVie inked the licensing, development, and commercialization agreement in 2018 for
this novel oncology drug to treat Hematological Cancers. Lupin’s MALT1 inhibitor developed as part
of its oncology pipeline had previously shown pre-clinical activity as a single agent as well as in
combination.

“This achievement is further validation of our ability to successfully develop novel treatments for
unmet needs. We look forward to continued successful development of this important treatment for
patients with difficult-to-treat cancers,” said Nilesh Gupta, Managing Director, Lupin. 

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The
Company develops and commercializes a wide range of branded and generic formulations, biotechnology
products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin
America (LATAM), Europe, and Middle East regions.
The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has
a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s
health areas. The company
invested 7.9% of its revenue in research and development in FY23.Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has
been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.

Read also: Lupin unveils Rufinamide Oral Suspension for seizure disorder in US

GEMCOVAC-OM is the first booster COVID-19 vaccine developed in India against the highly transmissible Omicron variant. GEMCOVAC-OM has demonstrated robust immune responses in the phase 3 clinical trial conducted at 20 centers across 13 cities in India In Phase-II/ III trials, approximately 3000 individuals received GEMCOVAC-OM and the vaccine was safe and well tolerated.

The currently approved vaccines used as precautionary/ booster doses are designed against the ancestral strain of SARS-CoV-2. Although these will increase the antibody titers, their ability to neutralize the circulating Omicron variant of SARS-CoV-2 is limited. Developing antibodies and memory immune responses specific to the Omicron variant would reduce the probability of infection and hospitalization and prevent future waves of the pandemic. The Made-in-India GEMCOVAC-OM specifically addresses this gap.

GEMCOVAC-OM is a lyophilized (freeze dried) vaccine, stable at 2- 8 °C.

It is delivered intradermally using a device called Tropis, developed by PharmaJet, USA. This is a needle-free device that obviates the disadvantages of using a needle, such as a needle phobia, sharps disposal, and needle-stick injuries, to name a few.

Dr. Sanjay Singh, CEO, Gennova Biopharmaceuticals Limited, said, “The Gennova team, as a part of the global scientific community’s endeavour to meet unmet medical needs, is geared for dealing with health emergencies. There is a realization that the COVID-19 will remain and keep mutating, and therefore we need to be prepared with vaccines to deal with emerging variants, The mRNA platform, that was developed in association with the Department of Biotechnology, Government of India, provides an opportunity for a quick turnaround for vaccine development for any variants of concern in future, if any. Vaccines have remained the best shield for mankind against deadly diseases.”

Reiterating Gennova’s pursuit of research for finding solutions for better health, Mr. Samit Mehta, COO, Gennova Biopharmaceuticals Limited, said, “Gennova has successfully developed India’s first Omicron-variant vaccine within a few months. Being aware of the accessibility challenges the world witnessed for the COVID-19 vaccines, we are happy that we are providing a vaccine based on a state-of-the-art technology, the mRNA. We are thankful to our stakeholders – medical fraternity, government, scientific community - for espousing confidence in our effort towards the mRNA technology and now the Omicron specific vaccine. The mRNA vaccine platform continues to remain a protective shield for India and the world against Coronavirus”.

Read also: NTAGI to discuss data of Gennova Pharma mRNA vaccine against COVID

Earlier this month, Coherus had said it would launch a biosimilar version of AbbVie's Humira, at an 85% discount to the list price of about $6,922, and partnered with Mark Cuban Cost Plus Drug Company to sell it at $569.27.

AbbVie had alleged a breach of an older agreement that granted Coherus a non-exclusive license to commercialize a biosimilar version of Humira in the United States from July 1.

In response, Coherus filed a restraining order against AbbVie to keep it from terminating the licensing deal.

This was followed by a preliminary injunction against Coherus, which still remains in place, though the companies have agreed that AbbVie would not terminate its licensing deal based on the notice.

The companies also agreed that AbbVie would have to serve another notice and give Coherus time to resolve the breach if it chooses to terminate the licensing agreement.

Read also: AbbVie plan to withdraw accelerated nods of Imbruvica in US for patients with certain types of blood cancer

Chennai: Caplin Steriles Limited, a Subsidiary company of Caplin Point
Laboratories Limited, has been granted final
approval by the United States Food and Drug Administration (USFDA) for its Abbreviated
New Drug Application (ANDA) Cisatracurium Besylate Injection USP, 10 mg/5 mL (2 mg/mL)
and 200 mg/20 mL (10 mg/mL) Single-dose Vials; and 20 mg/10 mL (2 mg/mL) Multiple-dose
Vials (Preserved).

The product is a generic therapeutic equivalent version of (RLD), NIMBEX injection of
AbbVie Inc.

Cisatracurium Besylate Injection USP is a nondepolarizing skeletal neuromuscular blocker,
indicated as an adjunct to general anesthesia to facilitate tracheal intubation and to provide
skeletal muscle relaxation during surgical procedures.

According to IQVIA (IMS Health),
Cisatracurium Besylate Injection USP had US sales of approximately $35 million for the 12-
month period ending December 2022. 

C. C. Paarthipan, Chairman of Caplin Point Laboratories Limited commented, “We’ve
been consistent with our filings and also happy to receive approvals on time. We’re creating a
healthy portfolio of products that we will launch not only in the US but in global markets as
well. This approval will augment our growth plans for Caplin Steriles this year and the years
going forward.”

Read also: Caplin Steriles bags USFDA nod for Ketorolac Tromethamine Injection

Caplin Steriles Limited, a Subsidiary of Caplin Point Laboratories Limited, is a niche sterile
product manufacturing company that is approved by several regulatory agencies such as US
FDA, EU-GMP and ANVISA. Caplin Steriles Limited, has developed and filed 30 ANDAs in USA
on its own and with partners, with 23 approvals so far, including this approval. The Company
is also working on a portfolio of 40+ simple and complex Injectable and Ophthalmic products,
that it intends to file over the next 4 years.

Read also: USFDA nod to Caplin Steriles Rocuronium Bromide Injection

Drugmakers hiked the price of these 43 drugs by more than the rate of inflation and are required to pay the difference of those medicines to Medicare, the federal health program for Americans over age 65."People taking 43 of these drugs could pay less (in coinsurance) to access these important treatments, starting July 1," Dr Meena Seshamani, director for Medicare at the Centers for Medicare & Medicaid Services (CMS) told reporters.The Medicare agency plans to send the first invoices to drugmakers in 2025 for the rebates owed to Medicare this year and for 2024.President Joe Biden's signature Inflation Reduction Act (IRA) includes a provision that penalises drugmakers for charging prices that rise faster than inflation for people on Medicare.Biden announced in March that his administration would subject 27 drugs to inflation fines for the second quarter of this year. The new list of 43 replaces that selection for the third quarter of 2023.The list of drugs facing the inflation penalty for the third quarter includes - for the second time - AbbVie's blockbuster arthritis drug Humira and Seagen's targeted cancer therapy Padcev, the White House said in a fact sheet.Read also: USFDA advisory committee votes unanimously to confirm clinical benefit of Leqembi for Alzheimer's Disease

Nilotpal Chatterjee, who works with Torrent Pharmaceuticals, told PTI that he went to the Midnapore Medical College and Hospital on Saturday for work and found many people injured in the train tragedy being brought there.

"Out of curiosity, I started enquiring about them and learnt that there are seven people who have lost their mobile phones, and do not remember any contact number of their family members. These are poor people who do not have any belongings left with them after the accident," he said.

"Soon, I posted their photos along with other details on Facebook. And those were shared by thousands of people, and I started getting calls from their relatives or people who know them, besides police and government officials," he said.

Chatterjee, 36, said most of these patients have multiple fractures, and were being not able to even speak properly.

The people he helped connect with their families are Gadadhar Sardar, Kabita Karmakar and Nakul Munda of Gosaba in South 24 Parganas, Naren Chowdhury of Goshthonagar in Malda, Sajjit Das of Alipurduar, Samir Kumar Mondal of Sonarpur in South 24 Parganas and Sudha Mondal of Santiniketan in Birbhum.

Sudha's family could not get in touch with her after the accident on Friday, Chatterjee said, adding that after failing to locate her at the hospitals in Odisha, her son-in-law Debiprasad Ghosh even went to the morgue of AIIMS-Bhubaneswar, thinking of the worst, before finally getting to know about her whereabouts.

He said it was the drive to do something for the people that made him take up the task, for which he has been spending most of the day at the Midnapore Medical College and Hospital.

The families that have been coming here from far-off places to take their loved ones home know nothing about Midnapore.

"We have been helping them with all kinds of things, including food and shelter," he said.

Chatterjee said several organisations, including Leftist organisation 'Red Volunteers', were working at the hospital to help the distraught people.

"We are taking them on stretchers for x-rays and MRIs, getting them medicines and providing all kinds of help that they need to get better," he said.

Three trains -- Shalimar-Chennai Coromandel Express, Bengaluru-Howrah Super Fast Express and a goods train -- were involved in the crash, now being described as one of India's worst train accidents.

The Coromandel Express crashed into a stationary goods train, derailing most of its coaches around 7 pm on Friday. A few passenger wagons of the Coromandel Express whiplashed the last few coaches of the Bengaluru-Howrah SF Express, which was passing by at the same time.

Investigators are looking into possible human error, signal failure and other causes behind the three-train crash that killed 275 people.

Read also: Odisha train accident: Expert doctors from Delhi to attend critically injured passengers